CHICAGO--(BUSINESS WIRE)--University Retina is proud to be among the first eyecare practices throughout the country to utilize and participate in Apellis Pharmaceuticals’ groundbreaking clinical trials for SYFOVRE, the first and only FDA-approved treatment for Geographic Atrophy (GA). GA is a leading cause of blindness that impacts more than one million people in the U.S. and five million people worldwide (source 1,2).
Within the past 3 years, University Retina has built their clinical trials program to be one of the largest programs in the Midwest for retinal and macular conditions. We have a full-time team dedicated to our clinical trials program and offer our patients the latest innovative drug and medical device therapeutics for treating retinal and macular diseases.
"We are incredibly excited to finally have a therapy for a true unmet need for many of our macular degeneration patients," said Dr. Veeral Sheth, Partner and Director of Clinical Trials, University Retina. "This therapy will allow many of our patients to maintain their independence and have a better quality of life as well as continue to do the things they love like reading, driving, and seeing the faces of their loved ones. I want to thank all of the patients that participated in the clinical trials whose time and effort have made it possible for countless others after them to benefit from this new therapy."
GA is an advanced form of Age-Related Macular Degeneration (AMD). It is a progressive and irreversible disease caused by the growth of lesions, which destroy the retinal cells responsible for vision. The vision loss caused by GA severely impairs independence and quality of life by making it difficult to participate in daily activities. On average, it takes only 2.5 years for GA lesions to start impacting the fovea, which is responsible for central vision (source 3).
“Today marks an extraordinary milestone for patients, the retina community, and Apellis. With its increasing effects over time and flexible dosing, we believe that SYFOVRE will make a meaningful difference in the lives of people with GA,” said Cedric Francois, M.D., Ph.D., Co-founder and Chief Executive Officer, Apellis. “GA is a complex disease that the field has spent decades trying to address, so we are humbled and proud to bring forward the first-ever treatment. Thank you to all who helped make this moment a reality.”
The approval of SYFOVRE is based on positive results from the Phase 3 OAKS and DERBY studies at 24 months across a broad and representative population of patients. SYFOVRE is approved for GA patients with or without subfoveal involvement and provides dosing flexibility for patients and physicians with a dosing regimen of every 25 to 60 days. In the OAKS and DERBY studies, SYFOVRE reduced the rate of GA lesion growth compared to sham and demonstrated increasing treatment effects over time, with the greatest benefit (up to 36% reduction in lesion growth with monthly treatment in DERBY) occurring between months 18-24.
“For the first time ever, we are celebrating the approval of a treatment for GA,” said Jeff Todd, President and Chief Executive Officer, Prevent Blindness. “This is a historic and hopeful day for all GA patients and their care partners, who have been waiting for a treatment for this relentless form of vision loss.”
The safety profile of SYFOVRE is well-demonstrated following ~12,000 injections. The most common adverse reactions (≥ 5%) reported in patients receiving SYFOVRE were ocular discomfort, neovascular AMD, vitreous floaters, and conjunctival hemorrhage. SYFOVRE is expected to be available by the beginning of March through specialty distributors and specialty pharmacies nationwide. A marketing authorization application for SYFOVRE is under review by the European Medicines Agency with a decision expected in early 2024. In addition, a marketing application has been submitted to Health Canada.
For further details about the SYFOVRE clinical study research, click here.
About University Retina:
University Retina is a full-service practice that specializes in helping patients heal eyesight-robbing diseases of the retina, vitreous, and macula. Led by a team of board-certified ophthalmologists and retina specialists, the practice has locations in Oak Forest, Bedford Park, Lemont, and Downers Grove, Illinois. With a dedication to education, technology, charity, and compassionate care, the University Retina team strives to provide patients with the highest level of retinal care in the world. The physicians diagnose and treat retinal-related conditions, including macular degeneration, diabetic retinopathy, retinal detachment repair, and other disorders of the retina, vitreous, and macula. All University Retina offices are equipped with state-of-the-art technology, and each patient’s treatment plan includes the most current and effective therapies or services available. The team at University Retina looks forward to helping you resolve your symptoms, regain your eye health, and live the healthiest life possible. To learn more, visit: www.uretina.com.
About Apellis:
Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company that combines courageous science and compassion to develop life-changing therapies for some of the most challenging diseases patients face. We ushered in the first new class of complement medicine in 15 years and now have two approved medicines targeting C3. These include the first and only therapy for geographic atrophy, a leading cause of blindness around the world. With nearly a dozen clinical and pre-clinical programs underway, we believe we have only begun to unlock the potential of targeting C3 across many serious diseases. For more information, please visit http://apellis.com or follow us on Twitter and LinkedIn.
Apellis Forward-Looking Statement:
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements regarding timing of the commercial availability of SYFOVRE. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including whether SYFOVRE will be commercially available when expected; whether clinical trials of SYFOVRE indicate an apparent positive effect that is greater than the actual positive effect, whether SYFOVRE will receive approval from foreign regulatory agencies for GA when expected or at all; and other factors discussed in the “Risk Factors” section of Apellis’ Annual Report on Form 10-K with the Securities and Exchange Commission on February 28, 2022 and the risks described in other filings that Apellis may make with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Apellis specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
Sources:
1 Rudnicka AR, Jarrar Z, Wormald R, et al. Age and gender variations in age-related macular degeneration prevalence in populations of European ancestry: a meta analysis. Ophthalmology 2012;119:571–580.
2 Wong WL, Su X, Li X, et al. Global prevalence of age-related macular degeneration and disease burden projection for 2020 and 2040: a systematic review and meta-analysis. Lancet Glob Health 2014;2:e106–116.
3 Lindblad AS, et al, and AREDS Research Group. Arch Ophthalmol. 2009;127(9):1168-1174.
