Cataract

ALISO VIEJO, Calif., Oct. 24, 2024 (GLOBE NEWSWIRE) -- RxSight, Inc., an ophthalmic medical device company dedicated to providing high-quality customized vision to patients following cataract surgery, today announced that it will report financial results for the third quarter of 2024 after the market close on Thursday, November 7, 2024. The company’s management will discuss the results during a conference call beginning at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time. To participate in the conference call, please dial (888) 596-4144 or (646) 968-2525, and enter the conference code: 7406253. The call will also be broadcast live in listen-only mode via a link on the company’s investor relations website at . An archived recording of the call will be available through the same link shortly after its completion. About RxSight, Inc. RxSight, Inc. is an ophthalmic medical device company dedicated to providing high-quality customized vision to patients following cataract surgery. The RxSight® Light Adjustable Lens system, comprised of the RxSight Light Adjustable Lens® (LAL™/LAL+™, collectively the “LAL”), RxSight Light Delivery Device (LDD™) and accessories, is the first and only commercially available intraocular lens (IOL) technology that can be adjusted after surgery, enabling doctors to customize and deliver high-quality vision to patients after cataract surgery. Additional information about RxSight can be found at . Company Contact: Shelley B. Thunen Chief Financial Officer sthunen@rxsight.com Investor Relations Contact: Oliver Moravcevic VP, Investor Relations omoravcevic@rxsight.com

88% of EYLEA HD patients had a last assigned dosing interval of ≥12 weeks at week 156, while sustaining visual and anatomic improvements achieved in the first 96 weeks, in this extension study of the Phase 3 PHOTON trial presented at AAO Patients switched to EYLEA HD experienced substantially slower fluid reaccumulation, as compared to their previous rate of fluid reaccumulation with EYLEA® (aflibercept) Injection 2 mg The consistent achievement of much longer dosing intervals with EYLEA HD – together with the notably slower fluid reaccumulation observed following switch to EYLEA HD – supports the longer duration of action of EYLEA HD versus EYLEA Safety data remains consistent with the known EYLEA HD and EYLEA safety profiles Oct. 18, 2024 -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced positive three-year (156-week) data for EYLEA HD® (aflibercept) Injection 8 mg from an extension study of the Phase 3 PHOTON trial in patients with diabetic macular edema (DME). At three years, the longer-term data showed the vast majority of EYLEA HD patients who entered the extension study sustained the visual gains and anatomic improvements achieved by the end of the second year, while achieving substantially longer treatment intervals than have been previously demonstrated. Notably, patients switched to EYLEA HD experienced substantially slower fluid reaccumulation following their first EYLEA HD dose. The achievement of much longer dosing intervals with EYLEA HD – together with the notably slower fluid reaccumulation – supports the longer duration of action of EYLEA HD. The results were presented today in a late-breaking session at the American Academy of Ophthalmology (AAO) Annual meeting. “Many patients with diabetic eye disease are of working age and often have to juggle a high burden of healthcare appointments and treatments alongside job and family commitments. These latest three-year results from the Phase 3 PHOTON trial continue to demonstrate that EYLEA HD can safely provide meaningful and lasting vision and anatomical benefits for people living with diabetic macular edema – with as few as three or four injections per year,” said Diana V. Do, M.D., Professor of Ophthalmology and Vice Chair for Clinical Affairs at the Byers Eye Institute, Stanford University and a trial investigator. “Over the last year, EYLEA HD has made an impact on how diabetic eye disease is managed among retina specialists, and these longer-term results reinforce confidence in initiating patients on EYLEA HD as a first-line treatment.” In PHOTON, EYLEA HD patients were initially randomized at baseline to either 12- or 16-week dosing intervals (after three initial monthly doses). If pre-specified criteria were met, dosing intervals could be shortened throughout the trial or extended in the second and third year. As previously presented, 89% of all EYLEA HD patients completing week 96 maintained ≥12-week dosing intervals. Patients could then participate in an optional extension study for an additional 60 weeks. Of the EYLEA HD patients (n=152) who completed the full 156 weeks of treatment: 88% were assigned a dosing interval of ≥12 weeks, and 48% were assigned a dosing interval of ≥20 weeks, at the end of three years of treatment. Vision gains and anatomical improvements achieved through year two in PHOTON were sustained through year three in the extension study. Patients in the PHOTON comparator arm received EYLEA® (aflibercept) Injection 2 mg as a fixed 8-week dosing regimen (after five initial monthly doses) for 96 weeks. These patients were then able to enter the extension study at week 96 and switch to a 12-week dosing interval with EYLEA HD. Of these patients who completed the extension study (n=58), 83% had a last assigned dosing interval ≥12 weeks at the end of the study (week 156), while mean visual and anatomic improvements achieved with EYLEA in the first 96 weeks were sustained following the switch to longer dosing intervals with EYLEA HD. Notably, patients synchronously switched to the EYLEA HD dose experienced substantially slower fluid reaccumulation following their first dose – as compared to their previous rate of fluid reaccumulation while on EYLEA treatment. The consistent achievement of much longer dosing intervals with EYLEA HD – together with the notably slower fluid reaccumulation observed following switch to EYLEA HD – support the longer duration of action of EYLEA HD versus EYLEA. In the extension study, the safety profile of EYLEA HD (n=265) continued to be similar to EYLEA through three years and remained generally consistent with the known safety profile of EYLEA HD in its pivotal trials. Ocular treatment emergent adverse events (TEAEs) occurring in ≥4% of all patients included cataract, vitreous floaters, and diabetic retinal edema. There were no cases of occlusive retinal vasculitis. The rate of intraocular inflammation was 1.4% for the patients that switched from EYLEA to EYLEA HD, and 1.5% for the EYLEA HD patients randomized at baseline. Anti-platelet trialists' collaboration-defined arterial thromboembolic TEAEs occurred in 7% of patients in both groups. EYLEA HD (known as Eylea™ 8 mg in the European Union and Japan) is being jointly developed by Regeneron and Bayer AG. In the U.S., Regeneron maintains exclusive rights to EYLEA and EYLEA HD. Bayer has licensed the exclusive marketing rights outside of the U.S., where the companies share equally the profits from sales of EYLEA and EYLEA HD. PULSAR in wet age-related macular degeneration and PHOTON in DME/diabetic retinopathy (DR) are double-masked, active-controlled pivotal trials that were conducted in multiple centers globally. In both trials, patients were randomized into 3 treatment groups to receive either: EYLEA HD every 12 weeks, EYLEA HD every 16 weeks, or EYLEA every 8 weeks. The lead sponsors of the trials were Bayer for PULSAR and Regeneron for PHOTON. Patients treated with EYLEA HD in both trials had 3 initial monthly doses, and patients treated with EYLEA received 3 initial doses in PULSAR and 5 in PHOTON. In the first year, patients in the EYLEA HD groups could have their dosing intervals shortened down to an every 8-week interval if protocol-defined criteria for disease progression were observed. Intervals could not be extended until the second year of the study. Patients in all EYLEA groups maintained a fixed 8-week dosing regimen throughout their participation in the two-year trials. In both studies, there was an optional extension study starting at week 96, with all participating patients receiving EYLEA HD through week 156. Patients initially randomized to EYLEA in PHOTON, were switched to EYLEA HD at the start of the extension study and immediately assigned to a 12-week dosing interval. Dosing intervals for all patients in the extension study could be shortened or extended by 2-week increments if protocol-defined criteria were met, with a minimum dosing interval of every 8 weeks and a maximum dosing interval of every 24 weeks. DR is an eye disease characterized by microvascular damage to the blood vessels in the retina often caused by poor blood sugar control in people with diabetes. The disease generally starts as nonproliferative diabetic retinopathy (NPDR) and often has no warning signs or symptoms. NPDR may progress to proliferative diabetic retinopathy (PDR), a stage of the disease in which abnormal blood vessels grow onto the surface of the retina and into the vitreous cavity, potentially causing severe vision loss. DME can occur at any stage of DR as the blood vessels in the retina become increasingly fragile and leak fluid, potentially causing visual impairment. In the U.S., approximately 1.5 million adults are diagnosed with DME, while approximately 6 million people have DR without DME. At Regeneron, we relentlessly pursue groundbreaking innovations in eye care science to help maintain the eye health of the millions of Americans impacted by vision-threatening conditions. Over a decade ago, our breakthrough scientific research resulted in the development of EYLEA, a vascular endothelial growth factor (VEGF) inhibitor designed to block the growth of new blood vessels and decrease the ability of fluid to pass through blood vessels in the eye. EYLEA has since brought fundamental change to the retinal disease treatment landscape and is supported by a robust body of research that includes eight pivotal Phase 3 trials, 12 years of real-world experience, and more than 80 million EYLEA injections globally. Regeneron continues to advance our anti-angiogenesis expertise with new solutions with the aim of offering optimal flexibility for a broad group of patients and eye care professionals. This includes EYLEA HD, which has been developed with the aim of extending the time between injections, while maintaining the vision gains, anatomic benefits and safety previously observed with EYLEA. Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases. Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as VelociSuite®, which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center® and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases. 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Phase 3 DIAMOND-1 and DIAMOND-2 trials enrollment of OCS-01 in diabetic macular edema (DME) accelerated with great momentumDIAMOND program committees expanded with globally renowned retina experts If approved, OCS-01 has the potential to transform the treatment paradigm as the first topical eye drop to treat DME ZUG, Switzerland, Oct. 21, 2024 (GLOBE NEWSWIRE) -- Oculis Holding AG (Nasdaq: OCS) (“Oculis”), a global biopharmaceutical company purposefully driven to save sight and improve eye care, today announces the acceleration of patient enrollment for both Phase 3 DIAMOND trials of OCS-01 eye drops in DME and expansion of the DIAMOND program committees with globally renowned retina experts. Substantial enrollment progress was achieved since the end of Q2 2024 through early October, with ~70% of patients enrolled in the Phase 3 DIAMOND-1 trial, and ~40% of patients enrolled in the Phase 3 DIAMOND-2 trial. The DIAMOND (DIAbetic Macular edema patients ON a Drop) program consists of two (2) Phase 3, double-masked, randomized, multi-center trials which will evaluate the efficacy and safety of OCS-01 eye drops in patients with DME. Arshad M. Khanani, M.D., M.A, FASRS, DIAMOND Program Steering Committee Chairperson, Oculis Board of Directors member, Scientific Advisory Board Chair of Retina and Director of Clinical Research at Sierra Eye Associates, commented: “I am honored to chair the DIAMOND steering committee, comprised of leading experts from around the globe, as we support the outstanding team at Oculis in the late-stage development of OCS-01. The results from Stage 1 of the DIAMOND Phase 3 program are promising, showing that patients treated with OCS-01 experienced significant improvements in visual acuity and a clinically meaningful reduction in macular edema. The DIAMOND program offers hope to the millions worldwide affected by DME, with OCS-01 potentially emerging as the first non-invasive topical eye drop therapy.” Riad Sherif, M.D., Chief Executive Officer of Oculis, said: ”We are very pleased with the strong momentum in patient enrollment in DIAMOND-1 and DIAMOND-2 Phase 3 trials which continues to exceed our expectations. We are also honored to have such a distinguished and broad group of global experts on the expanded DIAMOND program committees and look forward to working with the committees and benefiting from their deep expertise as we advance the DIAMOND program.” The DIAMOND program committees are comprised of world-renowned experts who provide strategic oversight as Oculis develops OCS-01 which has the potential to be the first topical eye drop to transform DME treatment paradigm: Arshad Khanani, M.D.David Almeida, M.D.Mark Barakat, M.D.Kirk Bateman, M.Sc.David Boyer, M.D.Margaret Chang, M.D.Saradha Chexal, M.D.Carl Danzig, M.D.Dilsher Dhoot, M.D.Diana Do, M.D.Frank Holz, M.D.Baruch D. Kuppermann, M.D.Timothy Lai, M.D.Anat Loewenstein, M.D.Sabri Markabi, M.D.Patricio Schlottmann, M.D.Ashish Sharma, M.D.Veeral Sheth, M.D.Michael Singer, M.D.Thomas Wolfensberger, M.D. For more information about the DIAMOND program committee members, please visit oculis.com. To learn more about the Phase 3 DIAMOND trials, please visit diamondtrial.com. About OCS-01 eye drops and the OPTIREACH® technology Leveraging Oculis’ proprietary technology, OCS-01 is an OPTIREACH® formulation of high concentration dexamethasone eye drop. It was developed to treat the retina via an eye drop, a route of administration for DME that contrasts with currently available therapies, all requiring invasive delivery to reach the retina such as intravitreal injections or ocular implants. The OPTIREACH® solubilizing formulation technology addresses the main limitations of conventional eye drops by improving the solubility of lipophilic drugs, increasing the residence time on the eye surface and thereby, enabling the drug passage from the eye surface to the posterior segment of the eye. Oculis’ OCS-01 is developed with the aim to transform the current treatment paradigm in DME as a non-invasive topical treatment option. OCS-01 is an investigational drug that has not received regulatory approval for commercial use in any country. About the Phase 3 DIAMOND Program of OCS-01 in Diabetic Macular Edema The DIAMOND-1 (DIAbetic Macular edema patients ON a Drop) and DIAMOND-2 trials are Phase 3, double-masked, randomized, multi-center trials which will evaluate the efficacy and safety of OCS-01 eye drops in patients with DME. Oculis aims to enroll 350 patients in each of these pivotal trials that will be randomized 1:1 to receive OCS-01 or vehicle six times daily for the 6-week induction phase and then three times daily through week 52 for the maintenance phase. The primary endpoint is change in best corrected visual acuity early treatment diabetic retinopathy study (BCVA ETDRS) letter score at Week 52. Secondary endpoints include percentage of patients with ≥15-letter gain in BCVA and change in central subfield thickness (CST), both at Week 52. Both trials were initiated upon the positive findings from stage 1 of the DIAMOND program, which was announced in the second quarter of 2023, and both trials are currently enrolling. About Diabetic Macular Edema (DME) DME is the leading cause of visual loss and legal blindness in patients with diabetes. Currently, it is estimated to affect around 37 million people worldwide and, with the rise of diabetes, the prevalence is expected to increase to 53 million by 20401,2. DME is an irreversible and progressive complication of diabetic retinopathy and is related to consistently having high blood sugar levels that damage nerves and blood vessels in the macula, the area of the retina responsible for sharp vision. DME occurs when blood vessels in the retina swell, and then leak, leading to a fluid build-up (edema) into the retina. There remains a significant need for safer, more effective, longer lasting, and less burdensome treatments for DME patients. About Oculis Oculis is a global biopharmaceutical company (Nasdaq: OCS; XICE: OCS) purposefully driven to save sight and improve eye care. Oculis’ highly differentiated pipeline comprises multiple innovative product candidates in development. It includes OCS-01, a topical eye drop candidate for diabetic macular edema (DME) and for the treatment of inflammation and pain following cataract surgery; licaminlimab (OCS-02), a topical biologic anti-TNFα eye drop candidate for dry eye disease (DED) and for non-infectious anterior uveitis; and OCS-05, a neuroprotective candidate for acute optic neuritis (AON). Headquartered in Switzerland and with operations in the U.S. and Iceland, Oculis’ goal is to improve the health and quality of life of patients worldwide. The company is led by an experienced management team with a successful track record and is supported by leading international healthcare investors. For more information, please visit: oculis.com (1) Yau et al. Global Prevalence and Major Risk Factors of Diabetic Retinopathy, Diabetes Care 2012 Mar; 35(3): 556-564 (2) International Diabetes Federation – diabetesatlas.org Estimated diabetes prevalence worldwide in 2021: 537m, reaching 783m in 2045 Oculis ContactsMs. Sylvia Cheung, CFOsylvia.cheung@oculis.com Investor & Media Relations LifeSci AdvisorsCorey Davis, Ph.D.cdavis@lifesciadvisors.com1-212-915-2577 Cautionary Statement Regarding Forward Looking StatementsThis press release contains forward-looking statements and information. For example, statements regarding the potential benefits of OCS-01, including patient impact and market opportunity; the potential of OCS-01 to become the first non-invasive eye drop therapy for DME; the potential of OCS-01 to treat both front and back of the eye indications; expected future milestones and catalysts; the initiation, timing, progress and results of Oculis’ clinical trials, including the progress of Oculis’ DIAMOND Phase 3 program with OCS-01 in DME; Oculis’ research and development programs, regulatory and business strategy, future development plans, and management; and Oculis’ ability to advance product candidates into, and successfully complete, clinical trials, are forward-looking. All forward-looking statements are based on estimates and assumptions that, while considered reasonable by Oculis and its management, are inherently uncertain and are inherently subject to risks, variability and contingencies, many of which are beyond Oculis’ control. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, assurance, prediction or definitive statement of a fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. All forward-looking statements are subject to risks, uncertainties and other factors that may cause actual results to differ materially from those that we expected and/or those expressed or implied by such forward-looking statements. Forward-looking statements are subject to numerous conditions, many of which are beyond the control of Oculis, including those set forth in the Risk Factors section of Oculis’ annual report on Form 20-F and any other documents filed with the U.S. Securities and Exchange Commission (the “SEC”). Copies of these documents are available on the SEC’s website, www.sec.gov. Oculis undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.