Uveal Melanoma

NEW YORK, March 19, 2024 /PRNewswire/ -- Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, announced today it will host a conference call on March 26, 2024, at 8:30 AM Eastern Time to discuss results for its fourth quarter and year ended December 31, 2023 and provide a business update. Conference Call Information To participate in this event, dial in approximately 5 to 10 minutes before the beginning of the call. Event Date: Tuesday, March 26, 2024 Time: 8:30 AM Eastern Time Participant Numbers: Toll Free: 1-833-630-1960 International: 1-412-317-1841 Webcast: Conference Replay About Delcath Systems, Inc., HEPZATO KIT and CHEMOSAT Delcath Systems, Inc. is an interventional oncology company focused on the treatment of primary and metastatic liver cancers. The company's proprietary products, HEPZATO KIT (Hepzato (melphalan) for Injection/Hepatic Delivery System) and CHEMOSAT® Hepatic Delivery System for Melphalan percutaneous hepatic perfusion (PHP) are designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects during a PHP procedure. In the United States, HEPZATO KIT is considered a combination drug and device product and is regulated and approved for sale as a drug by the FDA. HEPZATO KIT is comprised of the chemotherapeutic drug melphalan and Delcath's proprietary Hepatic Delivery System (HDS). The HDS is used to surgically isolate the liver while simultaneously filtrating hepatic venous blood during melphalan infusion and washout. The use of the HDS results in loco-regional delivery of a relatively high melphalan dose, which can potentially induce a clinically meaningful tumor response with minimal hepatotoxicity and reduce systemic exposure. HEPZATO KIT is approved in the United States as a liver-directed treatment for adult patients with metastatic uveal melanoma (mUM) with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation. Please see the full Prescribing Information, including BOXED WARNING for the HEPZATO KIT. In Europe, the device-only configuration of the HDS is regulated as a Class III medical device and is approved for sale under the trade name CHEMOSAT Hepatic Delivery System for Melphalan, or CHEMOSAT, where it has been used in the conduct of percutaneous hepatic perfusion procedures at major medical centers to treat a wide range of cancers of the liver. Please see the full Prescribing Information, including BOXED WARNING for the HEPZATO KIT. Contact: Investor Relations Contact: Ben Shamsian Lytham Partners 646-829-9701 [email protected] SOURCE Delcath Systems, Inc.

ATLANTA, March 19, 2024 (GLOBE NEWSWIRE) -- Alimera Sciences, Inc. (Nasdaq: ALIM) (“Alimera”), a global pharmaceutical company whose mission is to be invaluable to patients, physicians and partners concerned with retinal health and maintaining better vision longer, announces that the first patient has been randomized in the DRCR Retina Network’s Protocol AL. The study is titled, “A Randomized Clinical Trial Evaluating Intravitreal Faricimab (6.0 mg) Injections or Fluocinolone Acetonide (0.19 mg) Intravitreal Implants vs Observation for Prevention of Visual Acuity Loss due to Radiation Retinopathy.” The study, chaired by Arun Singh, M.D. (Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio), plans to include 600 participants with primary choroidal melanoma receiving treatment with plaque brachytherapy. It will assess development of macular edema and associated long-term visual acuity effects of consistent and continuous release of corticosteroid or repeated injections of anti-VEGF initiated near the time of radiation therapy compared to observation until macular edema develops in patients at risk for radiation retinopathy. “We are very excited that this study is underway as it has the potential to show ILUVIEN addressing another unmet need affecting the retina,” said Rick Eiswirth, President and Chief Executive Officer of Alimera. “We believe ILUVIEN with CONTINUOUS MICRODOSING™ delivery may prevent, delay or reduce the occurrence of the complication of radiation retinopathy and consequent vision loss when used in patients treated with plaque brachytherapy and look forward to the continuing progress of this study.” About Radiation Retinopathy Radiation retinopathy (RR) is a common complication after Iodine-125 plaque brachytherapy for choroidal melanoma. Although the initial radiation insult is immediate, clinical onset of RR is not seen until many months later and RR frequently progresses over time to profound vision loss. The Collaborative Ocular Melanoma Study reported that at three years, 45% of patients have visual acuity 20/200 or worse. A treatment that prevents the development of RR, or dampens its severity, would have important consequences for many of these eyes that may be successfully treated for choroidal melanoma but will likely develop severe RR and loss of vision over time. About the DRCR Retina Network (DRCR.net) The DRCR Retina Network was formed in 2002 and includes clinical sites and physicians throughout the United States and Canada. It is funded by the National Eye Institute (NEI), part of the National Institutes of Health, which is the federal government agency that funds medical research. The DRCR Retina Network is supported in overall operation and leadership by the office of the Network Chairs (Daniel F. Martin, M.D., Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio and Jennifer K. Sun, M.D., M.P.H., Joslin Diabetes Center, Harvard Medical School, Boston, Massachusetts) and the Coordinating Center (Executive Director Adam R. Glassman, M.S., Jaeb Center for Health Research, Tampa, FL), and the National Eye Institute (Project Officer, Sangeeta Bhargava, Ph.D.). About ILUVIEN The Company’s primary product is ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg sustained release intravitreal implant, injected into the back of the eye. With its CONTINUOUS MICRODOSING™ technology, ILUVIEN is designed to release sub-microgram levels of fluocinolone acetonide, a corticosteroid, for 36 months, to reduce the recurrence of disease, enabling patients to maintain vision longer with fewer injections. ILUVIEN is approved in the U.S., Kuwait, Lebanon and the U.A.E. to treat diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure. In 17 European countries, ILUVIEN is indicated for the treatment of vision impairment associated with chronic DME considered insufficiently responsive to available therapies. In March 2019, ILUVIEN received approval in the 17 countries under the Mutual Recognition Procedure for prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye. The 17 European countries include the U.K., Germany, France, Italy, Spain, Portugal, Ireland, Austria, Belgium, Denmark, Norway, Finland, Sweden, Poland, Czechia, the Netherlands, and Luxembourg. The non-infectious posterior uveitis indication for ILUVIEN was launched in Germany and the U.K. in late 2019, Belgium in 2021 and Spain and Italy in 2022. Alimera markets YUTIQ® (fluocinolone acetonide intravitreal implant) 0.18mg for treatment of uveitis in the United States. About Alimera Sciences, Inc. Alimera Sciences is a global pharmaceutical company whose mission is to be invaluable to patients, physicians and partners concerned with retinal health and maintaining better vision longer. For more information, please visit . Forward Looking Statements This press release contains “forward-looking statements,” within the meaning of the Private Securities Litigation Reform Act of 1995, regarding, among other things, Alimera’s expectations with respect to ILUVIEN’s potential to address another unmet need affecting the retina. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual results to differ materially from those projected in its forward-looking statements. Meaningful factors which could cause actual results to differ include, but are not limited to, ILUVIEN’s ability to prevent or reduce the occurrence of the complication of radiation retinopathy and consequent vision loss when used in patients treated with plaque brachytherapy, as well as other factors discussed in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Alimera’s Annual Report on Form 10-K for the year ended December 31, 2023 which is on the Securities and Exchange Commission (SEC) and available on the SEC’s website at All forward-looking statements contained in this press release are expressly qualified by the cautionary statements contained or referred to herein. Alimera cautions investors not to rely too heavily on the forward-looking statements Alimera makes or that are made on its behalf. These forward-looking statements speak only as of the date of this press release (unless another date is indicated). Alimera undertakes no obligation, and specifically declines any obligation, to publicly update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise. For press inquiries: Cassy Dump for Alimera Sciences 619-971-1887 cassydoespr@gmail.com For investor inquiries: Scott Gordon for Alimera Sciences scottg@coreir.com

FRIENDSWOOD, Texas--( BUSINESS WIRE )--Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced new data highlighting the value of its IDgenetix pharmacogenomic (PGx) test in guiding medication recommendations for patients with mental health conditions who are 65 and older. The data will be shared via a poster presentation at the 2024 American Association for Geriatric Psychiatry (AAGP) Annual Meeting, taking place March 15-18 in Atlanta. “Pharmacogenomics has been increasingly used to identify genetic variations associated with drug response; however, its potential in older adults who are more likely to be on multiple medications and experience adverse drug events has not been fully explored,” said Robert Cook, Ph.D., senior vice president of research and development at Castle Biosciences. “This study found that, despite all patients carrying potentially clinically significant genetic variants, one-third of medication recommendations were due to drug-drug interactions and lifestyle factors provided on the IDgenetix report. This is especially important as real-world evidence shows that polypharmacy, taking five or more prescription medications, occurs in more than half of elderly patients. 1 ” Poster Title: Pharmacogenomic Characteristics and IDgenetix-Guided Medication Management for Older Adults with Depression and Anxiety Presenting Author: Raymond A. Lorenz, Pharm.D., BCPP, Castle Biosciences, Inc. Date and Time: Saturday, March 16, from 5-7 p.m. Eastern Time Location: Grand Ballroom, Hanover Hall and Embassy Hall Exhibition Level at the Hyatt Regency Atlanta IDgenetix is an advanced 3-in-1 PGx test that incorporates genetic information, drug-drug interactions and lifestyle factors to produce a report that can help clinicians select optimal medications for their patients with depression, anxiety and other neuropsychiatric illnesses. The study analyzed gender, age and diagnosis, including attention-deficit/hyperactivity disorder, anxiety, bipolar disorder, depression, obsessive-compulsive personality disorder, pain, post-traumatic stress disorder and schizophrenia, from a sample of IDgenetix reports for patients 65 and older (n=737). The most common psychiatric diagnoses for which IDgenetix was ordered included depression and anxiety. Additionally, 58% of the patients in the study were on five or more medications, with an average of seven, at the time of testing. All patients in the study had genetic polymorphisms that could impact medication selection in at least three of the 15 genes on the IDgenetix report. While drug-gene interactions accounted for 66% of all medication recommendations, drug-drug interactions and lifestyle factors accounted for 34% (27% and 7%, respectively), demonstrating the value of the IDgenetix 3-in-1 test in providing tailored guidance to help clinicians select the optimal medications for their patients. About IDgenetix IDgenetix is a pharmacogenomic (PGx) test for depression, anxiety and other mental health conditions designed to analyze a patient’s genetic make-up to guide timely and evidence-based decisions on the optimal drug for each patient. IDgenetix is designed to provide important genetic information to clinicians to help guide personalized treatment plans for their patients, with the potential to help patients achieve a faster therapeutic response and improve their chances of remission by identifying appropriate medications more efficiently than the standard of care trial-and-error approach. IDgenetix provides drug-drug and drug-gene interactions and is supported by a published, peer-reviewed randomized controlled trial that demonstrated clinical utility over the standard of care when physicians used IDgenetix prior to prescribing a medication. IDgenetix is currently reimbursed by Medicare for the following eight mental health conditions: major depressive disorder, schizophrenia, bipolar disorder, anxiety disorders, panic disorder, obsessive-compulsive personality disorder, post-traumatic stress disorder and attention deficit hyperactivity disorder. About Castle Biosciences Castle Biosciences (Nasdaq: CSTL) is a leading diagnostics company improving health through innovative tests that guide patient care. The Company aims to transform disease management by keeping people first: patients, clinicians, employees and investors. Castle’s current portfolio consists of tests for skin cancers, Barrett’s esophagus, mental health conditions and uveal melanoma. Additionally, the Company has active research and development programs for tests in other diseases with high clinical need, including its test in development to help guide systemic therapy selection for patients with moderate-to-severe atopic dermatitis, psoriasis and related conditions. To learn more, please visit www.CastleBiosciences.com and connect with us on LinkedIn , Facebook , X and Instagram . DecisionDx-Melanoma, DecisionDx-CM Seq , DecisionDx-SCC, MyPath Melanoma, DiffDx-Melanoma, TissueCypher, IDgenetix, DecisionDx-UM, DecisionDx-PRAME and DecisionDx-UM Seq are trademarks of Castle Biosciences, Inc. Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the “safe harbor” created by those sections. These forward-looking statements include, but are not limited to, statements concerning: the potential of pharmacogenomics to affect medication recommendations for older adults; and the value of the IDgenetix 3-in-1 test in providing tailored guidance to help clinicians select the optimal medications for their patients. The words “believe,” “can” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that we make. These forward-looking statements involve risks and uncertainties that could cause our actual results to differ materially from those in the forward-looking statements, including, without limitation: subsequent study or trial results and findings may contradict earlier study or trial results and findings or may not support the results obtained in these studies, including with respect to the discussion of our tests in this press release; actual application of our tests may not provide the aforementioned benefits to patients; and the risks set forth under the heading “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2023, and in our other filings with the SEC. The forward-looking statements are applicable only as of the date on which they are made, and we do not assume any obligation to update any forward-looking statements, except as may be required by law. 1. Wang X, Liu K, Shirai K, et al. Prevalence and trends of polypharmacy in U.S. adults, 1999–2018. Glob Health Res Policy . 2023;8(25). https://doi-org.libproxy1.nus.edu.sg/10.1186/s41256-023-00311-4