This phase III trial compares the effectiveness of rituximab to mosunetuzumab in treating patients with follicular lymphoma with a low tumor burden. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Mosunetuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. It is not yet known if giving rituximab or mosunetuzumab works better in treating patients with follicular lymphoma with a low tumor burden.

Start Date23 Oct 2024

Sponsor / Collaborator

National Cancer Institute

CTRI/2024/09/073495 / Not yet recruitingNot ApplicableIIT

Effective of hyaluronidase as an adjuvant to bupivaciane for ultrasound guided pericapsular nerve group block in patient positioning for central neuraxial blockade: a randomised double-blind study. - NIL

Start Date16 Sep 2024

Sponsor / Collaborator-

100 Clinical Results associated with Hyaluronidase

100 Translational Medicine associated with Hyaluronidase

100 Patents (Medical) associated with Hyaluronidase

4,510

Literatures (Medical) associated with Hyaluronidase

31 Dec 2024·mAbs

Anti-HER2 biparatopic antibody KJ015 has near-native structure, functional balanced high affinity, and synergistic efficacy with anti-PD-1 treatment in vivo

Article

Author: Wang, Jinhua ; Lv, Baojie ; Cheng, Yu ; Liu, Chendan ; Xu, Qing ; Liu, Yu ; Hu, Ying ; Lu, Lin ; Wang, Zheng ; Zhu, Zhen ; Tang, Yao ; Zeng, Xin ; Lou, Junwen ; Wu, Peican ; Xu, Yunxia ; Liu, Yanjun ; Fang, Xin

Currently approved human epidermal growth factor receptor 2 (HER2)-targeted antibody therapies are largely derived from trastuzumab, including trastuzumab-chemotherapy combinations, fixed-dose trastuzumab-pertuzumab combinations, and trastuzumab antibody-drug conjugates. To expand the options, bispecific antibodies, which may better utilize the benefits of combination therapy, are being developed. Among them, biparatopic antibodies (bpAbs) have shown improved efficacy compared to monoclonal antibody (mAb) combinations in HER2-positive patients. BpAbs bind two independent epitopes on the same antigen, which allows fine-tuning of mechanisms of action, including enhancement of on-target specificity and induction of strong antigen clustering due to the unique binding mode. To fully utilize the potential of bpAbs for anti-HER2 drug development, it is crucial to consider formats that offer stability and high-yield production, along with a functional balance between the two epitopes. In this study, we rationally designed a bpAb, KJ015, that shares a common light chain with two Fab arms and exhibits functionally balanced high affinity for two HER2 non-overlapping epitopes. KJ015 demonstrated high-expression titers over 7 g/L and stable physicochemical properties at elevated concentrations, facilitating subcutaneous administration with hyaluronidase. Moreover, KJ015 maintained comparable antibody-dependent cytotoxicity, phagocytosis, and complement-dependent cytotoxicity with trastuzumab plus pertuzumab. It exhibited enhanced synergy when administered subcutaneously with hyaluronidase and anti-PD-1 mAb in a mouse tumor model, suggesting promising clinical prospects for this combination.

01 Dec 2024·Journal of Plastic, Reconstructive & Aesthetic Surgery

Late-onset periorbital edema in patients with a history of facial hyaluronic acid injection: A review on diagnosis and management

Review

Author: Eshraghi, Bahram ; Aghajani, Mahdi ; Babaei, Leila ; Aghajani, Ali

BACKGROUNDHyaluronic acid (HA) injections for soft tissue augmentation, particularly in the facial area, have become increasingly popular. Nevertheless, a growing number of reports indicate complications associated with this procedure, posing challenges for practitioners. One commonly encountered complication is periorbital edema.OBJECTIVETo review the existing literature on late-onset periorbital edema following HA injections, focusing on clinical presentation, proposed mechanisms, risk factors, diagnostics, and management strategies.METHODSA literature search was conducted to find articles describing findings on malar edema and eyelid edema following HA injections. The gathered data were categorized and juxtaposed to provide a clearer understanding of this phenomenon.RESULTSIncidence rates of periorbital edema post-HA injection vary, with delayed onset occurring weeks to years later. The manifestation involves diffuse edema in the eyelids and malar area, sometimes worsened by trigger factors like infections. Pathophysiology discussions distinguish between inflammatory and non-inflammatory causes, highlighting lymphatic and venous flow disturbances. Risk factors include filler characteristics, injection depth, and patient predispositions. Proper patient evaluation using ultrasonography aids in treatment planning, which could involve corticosteroids, hyaluronidase for HA removal, and subsequent cosmetic procedures like radiofrequency (RF) microneedling. Surgical interventions should be considered after HA dissolution, especially in cases requiring lower blepharoplasty.CONCLUSIONLate periorbital edema post-facial HA injections, once rare, is now frequently seen. Understanding and addressing this complication is essential for optimizing patient care and outcomes in clinical practice. Treatment typically involves adjusting hyaluronidase dosage for HA removal. Additional procedures like blepharoplasty, RF needling, or filler reinjection may enhance post-treatment appearance.

01 Nov 2024·Journal of Cosmetic Dermatology

Deliberations of the Safety Task Force: Risk factors and treatment of adverse events associated with aesthetic injectables

Article

Author: Cotofana, Sebastian ; Enright, Kaitlyn M. ; Cohen, Joel L. ; Lee, Won ; Schelke, Leonie ; Wang, Hang ; Cartier, Hugues ; Fabi, Sabrina ; Fitzgerald, Rebecca ; Avelar, Luiz ; Weiner, Steven ; Parada, Meire ; Goodman, Greg ; Nikolis, Andreas ; Biesman, Brian ; Beleznay, Katie ; Bromée, Torun ; Rzany, Berthold

AbstractBackgroundThe growing popularity of aesthetic procedures involving fillers, biostimulators, and neurotoxins has prompted concerns about patient safety. To address these concerns, a global Safety Task Force (STF) was formed.AimsThe inaugural STF meeting prioritized vascular compromise prevention and management, guiding clinical trial design and materials for future meetings, and collecting data from experts on current safety methods.MethodsThe STF was formed and consisted of 16 experts from nine different countries, with each possessing distinct expertise in various fields related to aesthetic injectables. Current safety data, protocols, knowledge gaps and future research priorities were discussed and voted upon.ResultsThe establishment of a global database for tracking filler‐related AEs was favored by 93% of participants. Discussions revolved around the database's scope, data standardization, and whether non‐medical contributors should be included. Aspiration as a safety technique garnered support from 73% of participants. Approximately 43% of participants incorporate ultrasound in their injections, with divergent opinions on its impact and potential when used as a standard of practice versus in AE management. Most physicians on the task force incorporated cannula use for some of their injections (93%). There were varying perspectives on treatments for vascular adverse events (VAE), the primary causes, and the adoption of new protocols in the field.ConclusionsThe STF meeting underscored the need for a coordinated effort to address complications related to HA fillers, including VAE management and hyaluronidase protocols. Reliable treatment endpoints were evaluated, but improved measurement methods are needed. Future meetings will focus on addressing delayed complications, furthering safety in this field.

News (Medical) associated with Hyaluronidase

17 Oct 2024

·www.globenewswire.com

New Data Presented at ASTRO 2024 Further Demonstrate the Safety and Efficacy of Barrigel™ Rectal Spacer, the First and Only Sculptable Hyaluronic Acid Rectal Spacer, in Patients Undergoing Radiation Therapy for Prostate Cancer(1-3)

• Barrigel™ rectal spacer provides high quality rectal spacing, enabling low dose to the rectum during prostate cancer radiation therapy, with an excellent toxicity and safety profile; and low incidence (0.32-1%) of rectal wall infiltration (RWI), which can be safely reversed using hyaluronidase4,5 • Data demonstrate safety and efficacy of Barrigel™ rectal spacer in stereotactic body radiation therapy (SBRT) for patients undergoing repeat therapy6 WAYNE, Pa., Oct. 17, 2024 (GLOBE NEWSWIRE) -- Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, today announced the presentation of data supporting the safety and efficacy of Barrigel™ rectal spacer, the first and only sculptable hyaluronic acid rectal spacer. It is designed to significantly reduce radiation that reaches the rectum during prostate cancer radiation therapy.1-3 The data were presented in three abstracts5-7 at the American Society for Radiation Oncology (ASTRO) 2024 Annual Meeting, which took place in Washington, DC, September 29 to October 2, 2024. Rectal spacers are used during prostate cancer radiation therapy to enable effective radiation dosing to the prostate while sparing healthy rectal tissue. This is especially important in hypofractionated treatment regimens, in which radiation is delivered at higher doses over a fewer number of treatment sessions. Unlike other rectal spacers made from different materials, which harden almost immediately after administration, the hyaluronic acid in Barrigel™ rectal spacer remains soft and pliable. This gives physicians time to sculpt, layer, and add more Barrigel™ rectal spacer as needed to optimize rectal protection.1,8-10 Additionally, Barrigel™ rectal spacer is highly visible in real time using transrectal ultrasound, which helps to ensure optimal spacing.1,8-10 Approximately 300,000 men will be diagnosed with prostate cancer this year in the U.S. alone. The incidence rate has increased by 3% per year overall over the past decade.11 “Building on the safety and efficacy of Barrigel™ rectal spacer previously proven in a randomized clinical trial,1 the data presented at ASTRO 2024 demonstrate that excellent outcomes can also be achieved in real-world settings and in patients undergoing repeat radiation therapy,” said Jacqueline Welch, Vice President of Global Clinical and Scientific Operations at Teleflex. “They also show that rare instances of unintended injection regions can be reversed with hyaluronidase, a naturally occurring enzyme. This is an important advantage over other rectal spacers, which cannot be reversed following the initial procedure and require time for biodegradation. Our ASTRO 2024 data underscore our ongoing commitment to advancing outcomes for patients with malignant and benign prostate conditions.” Presented Abstracts Impact of Hyaluronic Acid (HA) Rectal Spacer Quality Score (SQS) and Fischer-Valuck (FV) Spacer Symmetry Score on Rectal Dosimetry and Acute and Late Gastrointestinal (GI) Toxicity Outcomes – an Australian Experience (Abstract #3222)7 This abstract reports retrospective data from 100 men undergoing moderately fractionated EBRT (60Gy/62Gy in 20 fractions) for localized prostate cancer using Barrigel™ rectal spacer in Australia. Implants were assessed for quality (mSQS score), symmetry (FV score), and RWI (rectal wall infiltration), and acute and late gastrointestinal (GI) toxicity were also evaluated. Excellent implant quality (mSQS score=1) was reported for 74 patients; 24 patients had a score of 2 and only 2 patients had a 0 score. Symmetrical rectal spacing (FV score=1) was achieved in 97% of implants. Physicians deemed Barrigel™ rectal spacer very easy (98%) or easy (2%) to implant. No acute or late GI toxicity > Grade 2 was reported; 7 acute and 5 late Grade 1 toxicity events were reported. RWI occurred in 1 patient and was reversed with hyaluronidase with no subsequent adverse effects. Only 1 case of regional prostate cancer recurrence has been reported with median follow-up of 1.68 years. Rectal Wall Infiltration (RWI) with Hyaluronic Acid Based Rectal Spacer Reversal Protocol (Abstract #3185)5 This abstract reports data from a retrospective analysis of inadvertent RWI in 5,000 Australian men receiving Barrigel™ rectal spacer for prostate cancer radiation therapy. Results of magnetic resonance imaging (MRI) were used to identify RWI. Patients with RWI were followed for the remainder of their radiation therapy and for an additional 3 months following completion of radiation therapy. The study identified 16 patients (0.32%) with RWI after Barrigel™ rectal spacer insertion (Grade 1 by FV criteria n=5, Grade 2 n=6, Grade 3 n=5), with a median volume of misplaced Barrigel™ rectal spacer of 2.8 cc (total average Barrigel™ rectal spacer volume was 9.2 cc). No post-procedural GI symptoms or acute Grade 2+ GI toxicity were reported among these 16 men, and the rectal mucosa was intact in the 12 men who underwent sigmoidoscopy. Seven of the 16 men underwent Barrigel™ rectal spacer reversal procedures with hyaluronidase, all of which were successful, and no post-reversal complications were reported. The other 9 men were monitored. No severe adverse complications (mucosal ulceration, pelvic abscess, recto-prostatic fistula) have been reported among the 16 men with RWI. The presence of RWI resulted in delayed initiation of radiation therapy in 11 men (median delay = 3.2 months). “These real-world, retrospective analyses offer further evidence that Barrigel™ rectal spacer provides safe, effective, and high-quality spacing in routine clinical practice,” said Michael Chao, MD, a Radiation Oncologist at the Olivia Newton John Cancer Wellness & Research Centre in Victoria, Australia, and author on the two aforementioned abstracts.† “They also show that the incidence of RWI with Barrigel™ rectal spacer is quite rare—only 0.32%—and that these rare cases can be reversed effectively with hyaluronidase. Reversal is not feasible when RWI occurs with other spacers because the inorganic materials of which they are made cannot safely be dissolved in the body and must be absorbed over time. This is another important benefit of Barrigel™ rectal spacer that should be considered when selecting a rectal spacer for men undergoing prostate cancer radiation therapy.” Hyaluronic Acid Rectal Spacer in Locally Recurrent Prostate Cancer with Prior Radiation Receiving SBRT: on Feasibility, Safety, and Toxicity (Abstract #3236)6 This abstract reports Barrigel™ rectal spacer safety, rectal separation, ease of spacer placement, and treatment toxicity in 17 men undergoing repeat local radiation therapy for prostate cancer using SRBT. There was a 100% success rate for Barrigel™ rectal spacer placement, with no use of saline dissection and no adverse events reported. Mean minimum separation between gross tumor volume (GTV) and rectal tissue was 8.7 (± 5.6) mm, and adequate separation was achieved in 86.4% of cases. No >Grade 1 GI toxicity or acute Grade 3+ urinary toxicity were reported, and there was 1 case of Grade 3 hemorrhagic cystitis (which the patient also experienced during initial EBRT). Maximum point dose (Dmax) for radiation was 22.7 Gy (± 6.8), and the dose received by 30% (D30) and 60% (D60) of the prostate was 6.8 Gy (±3.0), and 3.0 Gy (± 2.2), respectively. “Patients with local recurrence of prostate cancer treated initially with EBRT (external beam radiation therapy) are often not considered for repeat radiation therapy,” said LaToya McLean, MD, a resident member at Thomas Jefferson University in Philadelphia, Pennsylvania and lead author on the abstract. “A key reason for this is concern about safely and effectively placing a rectal spacer in tissue that has been previously irradiated, as this tissue may be scarred or have adhesions that make it difficult to separate. In this study, we show that Barrigel™ rectal spacer can be used safely and effectively to achieve meaningful rectal separation that allows patients with local prostate cancer recurrence to receive radiation therapy while meeting dosimetric constraints. I hope these findings will help reduce the barriers to radiation therapy that these patients face.” About Barrigel™ Rectal Spacer Barrigel™ rectal spacer is the first and only hyaluronic acid rectal spacer that separates the prostate from the rectum to protect the rectum during radiation therapy treatment for prostate cancer.1 Barrigel is made from Non-Animal Stabilized Hyaluronic Acid (NASHA).12 Hyaluronic acid is a substance naturally present in the human body and is highly compatible and fully absorbable. NASHA has a proven history of safety and efficacy in a wide variety of medical applications in men, women and children worldwide.8,13 Barrigel™ rectal spacer has been proven to significantly reduce unwanted side effects from prostate cancer radiation therapy and is approved for rectal spacing in the United States, Australia, and Europe. Barrigel™ rectal spacer is indicated for prostate cancer patients with T1-T3b disease. For more information about Barrigel™ rectal spacer, please visit https://barrigel.com/hcp/barrigel-control-matters. Barrigel™ Rectal Spacer Important Safety InformationBarrigel is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and, in creating this space, it is the intent of Barrigel to reduce the radiation dose delivered to the anterior rectum. Barrigel is composed of biodegradable material and maintains space for the entire course of prostate radiotherapy treatment and is intended to be absorbed by the patient’s body over time. Barrigel should only be administered by qualified and properly trained physicians with experience in ultrasound guidance and injection techniques in the urogenital/pelvic area. As with any medical treatment, there are some risks involved with the use of Barrigel. Potential complications associated with the use of Barrigel include, but are not limited to: pain associated with Barrigel injection; needle penetration of the bladder, prostate, rectal wall, rectum, or urethra; injection of Barrigel into the bladder, prostate, rectal wall, rectum, urethra, or intravascularly; local inflammatory reactions; infection; urinary retention; rectal mucosal damage, ulcers, necrosis; bleeding; constipation; and rectal urgency. More information on indications, contraindications, warnings and instructions for use can be found in the Instructions For Use at www.barrigel.com. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. † Michael Chao is a paid consultant of Teleflex About Teleflex IncorporatedAs a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose driven innovation, and world-class products can shape the future direction of healthcare. Teleflex is the home of Arrow™, Barrigel™, Deknatel™, LMA™, Pilling™, QuikClot™ Rüsch™, UroLift™ and Weck™ – trusted brands united by a common sense of purpose. At Teleflex, we are empowering the future of healthcare. For more information, please visit teleflex.com. Forward-Looking StatementsAny statements contained in this press release that do not describe historical facts may constitute forward-looking statements. Any forward-looking statements contained herein are based on our management's current beliefs and expectations, but are subject to a number of risks, uncertainties and changes in circumstances, which may cause actual results or company actions to differ materially from what is expressed or implied by these statements. These risks and uncertainties are identified and described in more detail in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K. Teleflex, the Teleflex logo, Arrow, Barrigel, Deknatel, LMA, Pilling, QuikClot, Rüsch, Titan SGS, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries. All other trademarks are the property of their respective owners. © 2024 Teleflex Incorporated. All rights reserved. References: Mariados NF, Orio PF III, King MT et al. Hyaluronic acid spacer for hypofractionated prostate radiation therapy: A randomized clinical trial. JAMA Oncol. 2023:e1-e8.*King MT, Svatos M, Orio PF III et al. Evaluating the Quality-of-Life Effect of Apical Spacing with Hyaluronic Acid Prior to Hypofractionated Prostate Radiation Therapy: A Secondary Analysis, Pract Radiat Oncol. 2023;e1-e6.*Data on File. As of 06/01/2024.Hong A, Ischia J, Chao M. Case report: Reversal of hyaluronic acid rectal wall infiltration with hyaluronidase. Front Oncol. 2022;12:870388.Hong A, Bolton D, Ramani S et al. Rectal wall infiltration with hyaluronic acid based rectal spacer reversal protocol. Abstract #3185. Presented at ASTRO 2024 October 1, 2024.McLean L, et al. Hyaluronic Acid Rectal Spacer in Locally Recurrent Prostate Cancer with Prior Radiation Receiving SBRT: on Feasibility, Safety, and Toxicity. Abstract #3236. Presented at ASTRO 2024 October 1, 2024.Lin YH, et al. Impact of Hyaluronic Acid (HA) Rectal Spacer Quality Score (SQS) and Fischer-Valuck (FV) Spacer Symmetry Score on Rectal Dosimetry and Acute and Late Gastrointestinal (GI) Toxicity Outcomes – an Australian Experience. Abstract #3222. Presented at ASTRO 2024 October 1, 2024.Svatos M, Chell E, Low DA, et al. Symmetry, separation, and stability: Physical properties for effective dosimetric space with a stabilized hyaluronic acid spacer. Med Phys. 2024; 1-15. https://doi-org.libproxy1.nus.edu.sg/10.1002/mp.17292*Gejerman G, Goldstein MM, Chao M et al. Barrigel spacer injection technique. Pract Radiat Oncol. 2023:e1-e5. (Drs Gejerman, Chao, Lederer, and Orio are paid consultants of Palette Life Sciences, now part of Teleflex).Williams J, Mc Millan K, Chao M et al. Hyaluronic acid rectal spacer in EBRT: Usability, safety and symmetry related to user experience. J Med Imag Radiat Sci (2022).American Cancer Society. Key Statistics for Prostate Cancer. www.cancer.org. 2023. Accessed: Jan 26, 2023. https://www.cancer.org/cancer/types/prostate-cancer/about/key-statistics.Barrigel Injectable Gel Instructions for Use (2022).Restylane® celebrates 25 years of natural-looking results with its signature line of hyaluronic acid fillers. 2021. Available at: https://www.prnewswire.com/news-releases/restylane-celebrates-25-years-of-natural-looking-results-with-its-signature-line-of-hyaluronic-acid-fillers-301388779.html. Accessed Sept 30, 2021. *Study sponsored by Palette Life Sciences, now part of Teleflex. Contacts:TeleflexLawrence KeuschVice President, Investor Relations and Strategy Developmentinvestor.relations@teleflex.com610-948-2836 Media Contact:Glenn SilverPartner National Media Relations Specialistglenn.silver@finnpartners.com646-871-8485 APM943A

Radiation TherapyClinical ResultClinical StudyASCO

15 Oct 2024

·www.globenewswire.com

argenx Highlights Data Showing Patient Impact Across Multiple Immunology Programs at 2024 American Association of Neuromuscular & Electrodiagnostic Medicine Annual Meeting and Myasthenia Gravis Foundation of America Scientific Sessions

Long-term and real-world data of VYVGART® (efgartigimod alfa-fcab) and VYVGART® Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) demonstrate speed of onset, depth of response, and durability of response VYVGART demonstrates consistent, favorable safety profile from follow-up safety data that totals >8,000 patient years; no vaccinations required and no impact on human serum albumin levels Real-world data show more than 50 percent of gMG patients demonstrate substantial and sustained reduction in steroid use following VYVGART initiation argenx continues to expand its reach in neurology through pipeline programs, including empasiprubart advancing in MMN and ARGX-119 in ALS and CMS October 15, 2024 – 7:00am CET Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced the presentation of clinical and real-world data across its growing immunology pipeline at the 2024 American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) Annual Meeting and Myasthenia Gravis Foundation of America (MGFA) Scientific Sessions in Savannah, GA from October 15-18, 2024. “VYVGART continues to deliver impactful benefits to patients in terms of safety, speed of onset, depth of response, and durability of response,” said Luc Truyen, M.D., Ph.D., Chief Medical Officer, argenx. “The robust data we are showing at AANEM and MGFA continue to confirm VYVGART as the leading innovative biologic with an established ability to reduce steroid usage, drive minimal symptom expression for gMG patients, and reduce CIDP symptoms quickly. In addition to VYVGART, we are excited to highlight our growing neurology pipeline, including empasiprubart and ARGX-119, through which we can advance our mission of delivering transformative outcomes for even more patients.” VYVGART and VYVGART Hytrulo Demonstrate Rapid, Deep and Sustained Responses in gMG and CIDP The data presented at AANEM continue to demonstrate the significant impact of VYVGART (including VYVGART Hytrulo), the first-in-class neonatal Fc receptor (FcRn) blocker for people living with generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP). VYVGART is setting a new treatment standard in gMG and has shown rapid, deep and sustained responses, enabling a majority of patients to achieve minimal symptom expression (MSE) with a consistent and favorable safety profile and more than 8,000 patient years of safety data. Based on real-world data, more than half of patients can reduce steroid use by >5mg/day following VYVGART initiation. In CIDP, a majority of patients in the ADHERE trial responded to VYVGART Hytrulo and experienced reduced risk of relapse versus placebo and improvements in motor function and muscle strength, regardless of prior CIDP treatment. Highlights from VYVGART data presented at AANEM and MGFA: Early Line Use and Meaningful Steroid Reduction: VYVGART demonstrates consistent improvement across gMG patient subtypes, including those on mestinon alone, indicating its efficacy in early line use. Real-world gMG data show that at one-year post VYVGART initiation, 55% of patients reduced corticosteroid use by ≥5 mg/day and 42% of patients had achieved steroid doses of ≤5mg/day.Expansion to Seronegative and Ocular MG: argenx is honoring its long-term commitment to the broader MG community with two Phase 3 studies ongoing in additional MG patient populations, including seronegative (ADAPT-SERON) and ocular MG (ADAPT-OCULUS). Seronegative (AChR-) gMG patients evaluated in VYVGART clinical studies experienced consistent and clinically meaningful MG-ADL improvements, including patients achieving MSE.Sustained Functional Benefit in CIDP: VYVGART Hytrulo showed sustained functional benefit in motor function and muscle strength, regardless of prior treatment, which was maintained through ADHERE and the open-label extension study (through week 24).Consistent, Favorable Safety Profile: VYVGART’s consistent and favorable safety profile has been established across multiple autoimmune diseases with no increase in the incidence of adverse events with increased exposure. The unique safety profile of VYVGART is further supported by no black box warnings, no labs or immunoglobulin (Ig) monitoring, and no vaccination requirements. Advancing Immunology Pipeline Across Two First-in-Class Opportunities to Reach New Patients argenx will also highlight two additional pipeline candidates, including Phase 2 ARDA data of empasiprubart (anti-C2 inhibitor) for the treatment of multifocal motor neuropathy (MMN), and clinical trial designs of ARGX-119 (muscle-specific kinase (MuSK) agonist) for the treatment of congenital myasthenic syndromes (CMS) and amyotrophic lateral sclerosis (ALS). Cohort 1 data from the Phase 2 ARDA study will be presented in a poster, showing treatment with empasiprubart for MMN reduced the risk of IVIg retreatment by 91% (HR: 0.09 [95% CI: 0.02–0.44]) and demonstrated significant improvement in grip strength in both hands as compared to placebo. Data from a Patient Global Impression of Change scale show 94.4% of patients said they improved on empasiprubart from the start of the study, compared to 11.1% of placebo patients. As part of its commitment to the MMN community, argenx initiated the iMMersioN longitudinal study of ~150 patients to collect data on the impact of disease and burden of current treatment options on clinical outcomes and quality of life measures. A Phase 3 study of empasiprubart in MMN will start by the end of 2024. argenx posters included in MGFA Scientific Sessions All MGFA posters to be presented on Tuesday, October 15, 12:00 – 12:45pm ETPosters with an asterisk (*) will also be presented in AANEM scientific program Full TitlePresentation DetailsPatterns of Efgartigimod Dosing in Clinical Practice in the United StatesPoster # MG9Real-World Reduction in Oral Glucocorticoid Utilization at 1-Year Following Efgartigimod Initiation*Poster # MG31 / AANEM Poster # 262Efficacy, Safety, and Pharmacodynamics of Efgartigimod PH20 SC Across Bodyweight Quartiles: A Post hoc Analysis of the ADAPT-SC+ TrialPoster # MG32Fixed Cycle and Every-Other-Week Dosing of Intravenous Efgartigimod for Generalized Myasthenia Gravis: Part A of ADAPT NXT*Poster # MG33 /AANEM Poster # 182Design of a Phase 3 Randomized, Double-Blinded, Placebo-Controlled Study Evaluating the Efficacy and Safety of Subcutaneous Efgartigimod PH20 Administered by Prefilled Syringe in Adults with Ocular Myasthenia GravisPoster # MG38Phase 3 Trial Investigating Impact of Intravenous Efgartigimod in Anti-Acetylcholine Receptor Antibody Negative Generalized Myasthenia Gravis*Poster # MG39 / AANEM Poster # 178Observed Efficacy of Efgartigimod in Generalized Myasthenia Gravis Across Patient Subgroups in the ADAPT-SC+ StudyPoster # MG68Exploring the Impact of Non-Steroidal Immunosuppressive Drugs and Steroids on the Development of Comorbidities in Patients with Myasthenia Gravis in the National Veterans Affairs Health NetworkPoster # MG86Quality of Life of Patients with Symptomatic Ocular MG: Comparison with the General PopulationPoster # MG87Steroid Use, Toxicity, and Monitoring in Patients With Generalized Myasthenia Gravis: A Survey Of Neurologists In The United States*Poster # MG89 / AANEM Poster # 235Comparative Risk-Benefit Profiles of Immunomodulatory Therapies for Patients with Generalized Myasthenia GravisPoster # MG98 argenx posters included in AANEM Scientific Program * Session Times: Session I: Wednesday, October 16, 6:15 - 6:45pm ETSession II: Thursday, October 17, 9:30 - 10am ETSession III: Thursday, October 17, 2:45 - 3:15pm ET Full TitlePresentation Details*Long-Term Safety and Efficacy of Efgartigimod PH20 SC in Generalized Myasthenia Gravis: Interim Analysis of Anti-Acetylcholine Receptor Antibody Seronegative Participants in ADAPT-SC+Poster # 144Session I & Session IICombined Analyses of Participants With Anti-Acetylcholine Receptor Seronegative Generalized Myasthenia Gravis Treated With Efgartigimod Across Clinical StudiesPoster # 146Session I & Session IISafety, Tolerability, Pharmacokinetics, Immunogenicity, and Efficacy of ARGX-119 in Participants With DOK7 Congenital Myasthenic Syndromes: Phase 1b Study in ProgressPoster # 165Session I & Session IIIEfficacy and Safety of Subcutaneous Efgartigimod PH20SC in Chronic Inflammatory Demyelinating Polyneuropathy: ADHERE Trial Subgroup AnalysisPoster # 176Session I & Session IIEfficacy and Safety of Subcutaneous Efgartigimod PH20 in Chronic Inflammatory Demyelinating Polyneuropathy: ADHERE/ADHERE+ TrialPoster # 177Session I & Session IIISafety Profile of Intravenous Efgartigimod From Clinical Trials in Immunoglobulin G–Mediated Autoimmune DiseasesPoster # 180Session I & Session IISafety Profile of Subcutaneous Efgartigimod PH20 From Clinical Trials in Immunoglobulin G–Mediated Autoimmune DiseasesPoster # 181Session I & Session IIIEmpasiprubart (ARGX-117) in Multifocal Motor Neuropathy: Initial Safety and Efficacy Data of the Phase 2 ARDA StudyPoster # 198Session I & Session IILong-Term Safety, Tolerability, and Efficacy of Subcutaneous Efgartigimod PH20 in Participants With Generalized Myasthenia Gravis: Interim Results of the ADAPT-SC+ StudyPoster # 212Session I & Session IIISafety, Tolerability, Efficacy, Pharmacokinetics, and Immunogenicity of ARGX-119 in Patients with Amyotrophic Lateral Sclerosis: A Phase 2a Study in ProgressPoster # 237Session I & Session IIRisk of Serious Infections and Malignancies in Adult Myasthenia Gravis Patients: A US Claims Database StudyPoster # 251Session I & Session IIChronic Steroid Toxicity in Adults With Myasthenia Gravis in the United States Based on Electronic Health RecordsPoster # 263Session I & Session IISubcutaneous Efgartigimod PH20 in Chronic Inflammatory Demyelinating Polyneuropathy: Key Secondary Outcomes from the ADHERE TrialPoster # 280Session I & Session IIIEmpasiprubart (ARGX-117) in Multifocal Motor Neuropathy: Baseline Characteristics and MMN Confirmation Committee Outcome of the Phase ARDA Study Cohort 1Poster # 293Session I & Session IICOVID-19 Vaccination Response in Participants Receiving Efgartigimod IV or Efgartigimod PH20 SC in ADAPT+ or ADAPT-SC+Poster # 298Session I & Session IIISteroid Use, Toxicity, and Monitoring in Patients with Chronic Inflammatory Demyelinating Polyneuropathy: A Survey of Neurologists in The United StatesPoster # 306Session I & Session IIIClinical Outcomes, Disease Course, and Quality of Life in Patients With Multifocal Motor Neuropathy: iMMersioN, Study in ProgressPoster # 307Session I & Session II More information on the data presented at the 2024 AANEM Annual Meeting can be found here. See FDA-approved Important Safety Information below, full Prescribing Information for VYVGART and full Prescribing Information for VYVGART Hytrulo for additional information. Important Safety Information What is VYVGART® (efgartigimod alfa-fcab)?VYVGART is a prescription medicine used to treat a condition called generalized myasthenia gravis, which causes muscles to tire and weaken easily throughout the body, in adults who are positive for antibodies directed toward a protein called acetylcholine receptor (anti-AChR antibody positive). IMPORTANT SAFETY INFORMATIONDo not use VYVGART if you have a serious allergy to efgartigimod alfa or any of the other ingredients in VYVGART. VYVGART can cause serious allergic reactions and a decrease in blood pressure leading to fainting. VYVGART may cause serious side effects, including: Infection. VYVGART may increase the risk of infection. The most common infections were urinary tract and respiratory tract infections. Signs or symptoms of an infection may include fever, chills, frequent and/or painful urination, cough, pain and blockage of nasal passages/sinus, wheezing, shortness of breath, fatigue, sore throat, excess phlegm, nasal discharge, back pain, and/or chest pain.Allergic Reactions (hypersensitivity reactions). VYVGART can cause allergic reactions such as rashes, swelling under the skin, and shortness of breath. Serious allergic reactions, such as trouble breathing and decrease in blood pressure leading to fainting have been reported with VYVGART.Infusion-Related Reactions. VYVGART can cause infusion-related reactions. The most frequent symptoms and signs reported with VYVGART were high blood pressure, chills, shivering, and chest, abdominal, and back pain. Tell your doctor if you have signs or symptoms of an infection, allergic reaction, or infusion-related reaction. These can happen while you are receiving your VYVGART treatment or afterward. Your doctor may need to pause or stop your treatment. Contact your doctor immediately if you have signs or symptoms of a serious allergic reaction. Before taking VYVGART, tell your doctor if you: take any medicines, including prescription and non-prescription medicines, supplements, or herbal medicines,have received or are scheduled to receive a vaccine (immunization), orhave any allergies or medical conditions, including if you are pregnant or planning to become pregnant, or are breastfeeding. What are the common side effects of VYVGART?The most common side effects of VYVGART are respiratory tract infection, headache, and urinary tract infection. These are not all the possible side effects of VYVGART. Call your doctor for medical advice about side effects. You may report side effects to the US Food and Drug Administration at 1-800-FDA-1088. Please see the full Prescribing Information for VYVGART and talk to your doctor. What is VYVGART® HYTRULO (efgartigimod alfa and hyaluronidase-qvfc)?VYVGART HYTRULO is a prescription medicine used to treat a condition called generalized myasthenia gravis, which causes muscles to tire and weaken easily throughout the body, in adults who are positive for antibodies directed toward a protein called acetylcholine receptor (anti-AChR antibody positive).VYVGART HYTRULO is a prescription medicine used for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP) IMPORTANT SAFETY INFORMATIONDo not use VYVGART HYTRULO if you have a serious allergy to efgartigimod alfa, hyaluronidase, or any of the other ingredients in VYVGART HYTRULO. VYVGART HYTRULO can cause serious allergic reactions and a decrease in blood pressure leading to fainting. VYVGART HYTRULO may cause serious side effects, including: Infection. VYVGART HYTRULO may increase the risk of infection. The most common infections for efgartigimod alfa-fcab-treated patients were urinary tract and respiratory tract infections. Signs or symptoms of an infection may include fever, chills, frequent and/or painful urination, cough, pain and blockage of nasal passages/sinus, wheezing, shortness of breath, fatigue, sore throat, excess phlegm, nasal discharge, back pain, and/or chest pain.Allergic Reactions (hypersensitivity reactions). VYVGART HYTRULO can cause allergic reactions such as rashes, swelling under the skin, and shortness of breath. Hives were also observed in patients treated with VYVGART HYTRULO. Serious allergic reactions, such as trouble breathing and decrease in blood pressure leading to fainting have been reported with efgartigimod alfa-fcab.Infusion-Related Reactions. VYVGART HYTRULO can cause infusion-related reactions. The most frequent symptoms and signs reported with efgartigimod alfa-fcab were high blood pressure, chills, shivering, and chest, abdominal, and back pain. Tell your doctor if you have signs or symptoms of an infection, allergic reaction, or infusion-related reaction. These can happen while you are receiving your VYVGART HYTRULO treatment or afterward. Your doctor may need to pause or stop your treatment. Contact your doctor immediately if you have signs or symptoms of a serious allergic reaction. Before taking VYVGART HYTRULO, tell your doctor if you: take any medicines, including prescription and non-prescription medicines, supplements, or herbal medicines,have received or are scheduled to receive a vaccine (immunization), orhave any allergies or medical conditions, including if you are pregnant or planning to become pregnant, or are breastfeeding. What are the common side effects of VYVGART HYTRULO?The most common side effects in efgartigimod-alfa-fcab-treated patients were respiratory tract infection, headache, and urinary tract infection. Additional common side effects with VYVGART HYTRULO are injection site reactions, including rash, redness of the skin, itching sensation, bruising, pain, and hives. These are not all the possible side effects of VYVGART HYTRULO. Call your doctor for medical advice about side effects. You may report side effects to the US Food and Drug Administration at 1-800-FDA-1088. Please see the full Prescribing Information for VYVGART HYTRULO and talk to your doctor. About VYVGARTVYVGART is a human IgG1 antibody fragment that binds to the neonatal Fc receptor (FcRn), resulting in the reduction of circulating IgG autoantibodies. It is the first approved FcRn blocker in the United States, EU, China and Canada for the treatment of adults with generalized myasthenia gravis (gMG) who are anti- acetylcholine receptor (AChR) antibody positive and in Japan for the treatment of adults with gMG who do not have sufficient response to steroids or non-steroidal immunosuppressive therapies (ISTs). About VYVGART® HytruloVYVGART Hytrulo is a subcutaneous combination of efgartigimod alfa, a human IgG1 antibody fragment marketed for intravenous use as VYVGART®, and recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE® drug delivery technology to facilitate subcutaneous injection delivery of biologics. In binding to the neonatal Fc receptor (FcRn), VYVGART Hytrulo results in the reduction of circulating IgG. It is the first-and-only approved FcRn blocker administered by subcutaneous injection. VYVGART Hytrulo is the proprietary name in the U.S. for subcutaneous efgartigimod alfa and recombinant human hyaluronidase PH20. It may be marketed under different proprietary names following approval in other regions. About Generalized Myasthenia Gravis (gMG)Generalized myasthenia gravis (gMG) is a rare and chronic autoimmune disease where IgG autoantibodies disrupt communication between nerves and muscles, causing debilitating and potentially life-threatening muscle weakness. Approximately 85% of people with MG progress to gMG within 24 months,1 where muscles throughout the body may be affected. Patients with confirmed AChR antibodies account for approximately 85% of the total gMG population. About Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)Chronic inflammatory demyelinating polyneuropathy (CIDP) is a rare and serious autoimmune disease of the peripheral nervous system. Although confirmation of disease pathophysiology is still emerging, there is increasing evidence that IgG antibodies play a key role in the damage to the peripheral nerves. People with CIDP experience fatigue, muscle weakness and a loss of feeling in their arms and legs that can get worse over time or may come and go. These symptoms can significantly impair a person's ability to function in their daily lives. Without treatment, one-third of people living with CIDP will need a wheelchair. About EmpasiprubartEmpasiprubart (ARGX-117) is a first-in-class humanized monoclonal antibody that binds C2 and blocks activation of both the classical and lectin pathways of the complement cascade, leaving the alternative pathway intact for its antimicrobial properties. By blocking complement activity upstream of C3 and C5, empasiprubart has the potential to reduce tissue inflammation and cellular damage, representing a broad pipeline opportunity across multiple severe autoimmune indications. In addition to multifocal motor neuropathy, argenx is evaluating empasiprubart in delayed graft function following kidney transplant, dermatomyositis and chronic inflammatory demyelinating polyneuropathy. About Multifocal Motor NeuropathyMultifocal motor neuropathy (MMN) is a rare, severe, chronic autoimmune disease of the peripheral nervous system. The disease is characterized by slowly progressive, asymmetric muscle weakness mainly of the hands, forearms and lower legs. MMN is often associated with the presence of anti-GM1 IgM autoantibodies, leading to activation of the classical complement pathway, driving subsequent axon damage. High-dose IVIg is the only approved treatment for MMN and patients typically experience disease progression despite therapy, indicating an unmet need for efficacious and better tolerated therapeutic options. About ARGX-119ARGX-119 is a humanized agonistic monoclonal antibody (mAb) that targets and activates muscle-specific kinase (MuSK) to promote maturation and stabilization of the neuromuscular junction (NMJ). MuSK is a receptor kinase that has a critical role in the structure and function of the NMJ. ARGX-119 is being developed as a potential therapy for patients with neuromuscular disease. About Congenital Myasthenic Syndromes (CMS) Congenital Myasthenic Syndromes (CMS) are a heterogenous group of rare genetic disorders of the neuromuscular junction (NMJ) that lead to muscle weakness. CMS cases are classified into subtypes depending on the underlying genetic mutation. While clinical features vary widely across and within subtypes, the predominant manifestation of CMS is fatigable weakness. Age of onset varies widely; while many patients are diagnosed in infancy or early childhood, patients with milder phenotypes may not present or be diagnosed until adulthood. About Amyotrophic Lateral Sclerosis (ALS) ALS is a neurodegenerative disorder of the brain and spinal cord leading to deteriorating muscle function, weakness and atrophy. The multisystemic nature can have impacts throughout the body with specific signs and symptoms associated with lower motor neuron and upper motor neuron loss. Life expectancy is typically 2.5-5 years from diagnosis. About argenxargenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx developed and is commercializing the first approved neonatal Fc receptor (FcRn) blocker in the U.S., Japan, Israel, the EU, the UK, Canada and China. The Company is evaluating efgartigimod in multiple serious autoimmune diseases and advancing several earlier stage experimental medicines within its therapeutic franchises. For more information, visit www.argenx.com and follow us on LinkedIn, X/Twitter, Instagram, Facebook, and YouTube. ContactsMedia:Ben Petokbpetok@argenx.com Investors:Alexandra Roy (US)aroy@argenx.com Lynn Elton (EU)lelton@argenx.com Forward-Looking Statements The contents of this announcement include statements that are, or may be deemed to be, “forward-looking statements.” These forward-looking statements can be identified by the use of forward-looking terminology, including the terms “aim,” and “will,” and include statements argenx makes regarding the anticipated timing of the initiation of the Phase 3 clinical trial for empasiprubart in MMN and its goal of translating immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. argenx’s actual results may differ materially from those predicted by the forward-looking statements as a result of various important factors, including the results of argenx's clinical trials; expectations regarding the inherent uncertainties associated with the development of novel drug therapies; preclinical and clinical trial and product development activities and regulatory approval requirements in products and product candidates; the acceptance of argenx's products and product candidates by patients as safe, effective and cost-effective; the impact of governmental laws and regulations on our business; disruptions caused on our reliance of third-party suppliers, service providers and manufacturers; inflation and deflation and the corresponding fluctuations in interest rates; and regional instability and conflicts. A further list and description of these risks, uncertainties and other risks can be found in argenx’s U.S. Securities and Exchange Commission (SEC) filings and reports, including in argenx’s most recent annual report on Form 20-F filed with the SEC as well as subsequent filings and reports filed by argenx with the SEC. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. argenx undertakes no obligation to publicly update or revise the information in this press release, including any forward-looking statements, except as may be required by law. ###

Clinical ResultPhase 2Phase 3Phase 1

01 Oct 2024

·www.pharmaceutical-technology.com

Genentech buys Regor’s CDK inhibitors in $850m deal

Roche announced the agreement at its annual pharma day in London, UK. Image shows Roche’s head office in California, USA. Credit: Michael Vi via Shutterstock. Genentech is strengthening its oncology pipeline by acquiring Regor Pharmaceuticals’ portfolio of breast cancer cyclin-dependent kinase (CDK) inhibitors in an $850m deal. The deal, anticipated to close in Q4 2024, was unveiled by Genentech’s parent company Roche at its pharma day in London. The pharmaceutical giant also shared that it is focusing on three major therapeutic areas – one being oncology. Regor will continue to oversee its two ongoing Phase I trials of the CDK4/2 inhibitor RGT-419B until their completion. At that point, Genentech will take over the global clinical development, manufacturing, and commercialisation of the candidate. The deal also includes preclinical candidate RGT-587, which is a “Phase I ready” CDK4 inhibitor, intended to treat brain metastases. One of Regor’s Phase Ia trials (NCT05304962) is investigating RGT-419B in 12 patients with HR+/HER2-negative advanced breast cancer who had previously undergone CDK4 treatment. Data showed that RGT-419B, administered as a monotherapy, achieved a 28.6% partial response rate and a 44% clinical benefit rate with no dose-limiting toxicities observed. The other Phase I trial (NCT06299124) is enrolling 40 subjects in China and is set to conclude at the end of this year. In the announcement accompanying the deal, Regor’s CEO Xiayang Qiu said: “Genentech is well-positioned to bring these novel therapeutics to their full potential to benefit patients with breast cancer around the world.” See Also: Fresenius Kabi wins FDA approval for Stelara biosimilar Otulfi BMS and Prime ink potential $3.5bn deal to develop T cell therapies During Roche’s 30 September presentation, CEO Teresa Graham said CDK inhibitors are “a perfect fit” with the company’s breast cancer franchise. Graham also touted some of the breast cancer assets that Roche already has on the market, including Phesgo (hyaluronidase, pertuzumab and trastuzumab), Kadcyla (trastuzumab emtansine), and Perjeta (pertuzumab). These three assets pulled in global sales of $1.25bn, $2.2bn, and $4.2bn respectively in 2023, as per Roche’s financials. Graham also highlighted inavolisib, a first-line PIK3CA-mutated hormone receptor for positive breast cancer. The candidate has a 27 November PDUFA date. Several companies have struck deals to acquire CDK inhibitors, targeted therapies that block proteins that regulate cell division to slow or stop the growth of cancer cells. In July 2024, Exscientia acquired a CDK7 inhibitor being trialled in patients with advanced or metastatic solid tumours. This is after buying out its development partner Apeiron Therapeutics’ shares of the programme. However, Roche’s global head of oncology and haematology product development Charles Fuchs highlighted that there is an unmet need for agents targeting CDK4/6i resistance, with most patients progressing after CDK4/6i treatment. According to Regor, RGT-419B is the most advanced CDK4/2 inhibitor in the clinic. It’s not the first time Regor has struck a deal with a big pharma company. In December 2021, the biotech entered into a $1.5bn agreement with Eli Lilly to discover, develop and market new treatments for metabolic disorders. Under the terms of the deal, Lilly secured a licence to select the intellectual property of Regor with an option for a licence extension.

Phase 1License out/inDrug ApprovalClinical Result

100 Deals associated with Hyaluronidase

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KEGG	Wiki	ATC	Drug Bank
D04455	-	-	DB00070

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Urethral Diseases	US	Bausch & Lomb, Inc.	05 May 2004

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Nonproliferative diabetic retinopathy	Discovery	US	Bausch & Lomb, Inc.	01 Jul 2005
Vitreous Detachment	Discovery	US	Bausch & Lomb, Inc.	01 Jul 2005
Pain	Discovery	US	Bausch & Lomb, Inc.	01 Oct 2004
Drug Hypersensitivity	Discovery	US	Bausch & Lomb, Inc.	01 Mar 2004
Diabetic Retinopathy	Discovery	CA	Bausch & Lomb, Inc.	01 Nov 1998
Diabetic Retinopathy	Discovery	US	Bausch & Lomb, Inc.	01 Nov 1998
Diabetic Retinopathy	Discovery	MX	Bausch & Lomb, Inc.	01 Nov 1998
Vitreous Hemorrhage	Discovery	MX	Bausch & Lomb, Inc.	01 Nov 1998
Vitreous Hemorrhage	Discovery	US	Bausch & Lomb, Inc.	01 Nov 1998
Vitreous Hemorrhage	Discovery	CA	Bausch & Lomb, Inc.	01 Nov 1998

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


WCD2023	Not Applicable	Keloid	100	Triamcinolone acetonide + 5-fluorouracil	ekoasrjfcf(uumlkinnxk) = fbmindfbun vdvilifjay (ltenzzxyxg ) View more	-	04 Jul 2023
				Triamcinolone acetonide + 5-fluorouracil + Hyaluronidase	ekoasrjfcf(uumlkinnxk) = pvchykxizy vdvilifjay (ltenzzxyxg )
EULAR2010	Not Applicable	Hydrarthrosis	-	Hyaluronidase	hraiaegxix(dajjdrratx) = olzcfefkzw kmqknovpfb (phvjmpnius )	-	16 Jun 2010
ARVO2009	Not Applicable	-	-	Vitrase	xgyaivevhp(nkzqmuwfzv) = pkgjccqatk riucqnuvyf (xtfgycyrrh )	Positive	01 Apr 2009
				Vitrase-lidocaine	xgyaivevhp(nkzqmuwfzv) = vfxdwtmrds riucqnuvyf (xtfgycyrrh )
ARVO2007	Not Applicable	-	-	Plasmin + Hyaluronidase	(dcplxukzrj) = jsffqfhghg uwaxahqeom (najfxaauqt ) View more	-	01 May 2007
				Plasmin	(dcplxukzrj) = jjbrknghfx uwaxahqeom (najfxaauqt ) View more
ARVO2006	Not Applicable	-	-	Vitrase	wjsuhdcgxg(mksrjhgjxs) = hobptkeeon pjsslbgodo (rjfjardgkm )	-	01 May 2006
ARVO2004	Phase 3	Vitreous Hemorrhage	742	Vitrase 7.5 IU	(gijgpvnmnq) = ttbxveewxr ryvjdjmihz (sygkelparj )	-	01 May 2004
				Vitrase 55 IU	etvcrfjemm(lnzghdxgqu) = dwdpxfqhbf oqbymladiq (wssmthgztn ) View more
ARVO2003	Phase 3	Vitreous Hemorrhage	-	Vitrase 7.5 IU	(somfazokyi) = Most resolved by month 1 qjwvxdiukf (eopbsawynl ) View more	Positive	01 May 2003
				Vitrase 55 IU
ARVO2002	Not Applicable	Diabetic Retinopathy	-	Saline	(uypgsntsdv) = Reduced visual acuity across all treatment groups in these diabetic eyes was the most frequently reported ocular adverse event zyogqfvclx (wqbtqebwlx )	Positive	01 Dec 2002
				Vitrase
AAO2000	Not Applicable	Diabetes Mellitus	-	Hyaluronidase	xiqgyfukej(yghuzwtgzd) = zyxgenfgur ywvinflnpp (skiptmpnlg )	Positive	23 Oct 2000

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