On February 17, 2023, the FDA approved the first-ever treatment for advanced dry age-related macular degeneration (AMD), also known as geographic atrophy (GA). In clinical trials, the drug SYFOVRE slowed the progression of GA with an increasing effect over the course of treatment. The drug from Apellis is approved for all GA patients and allows for flexibility in dosing from 25 to 60 days. The treatment demonstrated a high safety profile following 23,000 injections over 24 months in clinical trials. The most common adverse reactions, affecting about 5% of patients, were ocular discomfort, floaters, and broken blood vessels. However, a safety update was issued by Apellis a few months after the drug became available.
On August 23, 2023, Fierce Pharma reported that Apellis flagged needle problems related to the administration of Syforvre injections. The advisory is in response to a rare but potentially blinding side effect of retinal vasculitis, which blocks blood flow to the retina.
Advanced dry-AMD / GA affects approximately 1 million people in the U.S. and 5 million worldwide. It is a continuation of the dry form of macular degeneration, where there is a loss of retinal cells, resulting in blind spots. These blind spots usually develop just outside the center of your vision but may progress to involve the center over time. Progressive vision loss can lead to legal blindness, impacting independence and quality of life.
Patients and healthcare providers can call Apellis Assist at 888-273-5547 for information and support. Prior FDA approved treatments in use were developed for advanced neovascular or wet-AMD in which abnormal blood vessels develop underneath the retina and cause bleeding and swelling of the macula. This happens in approximately 10% of all cases of AMD. Common symptoms include blurriness and waviness or loss of central vision.
On August 4, 2023, the FDA approved a second injectable treatment for advanced dry-AMD. The drug, IZERVAY, from Astellas Pharma Inc., was shown to slow disease progression in global Phase 3 clinical trials. IZERVAY treatment will be available, in the U.S., September 2023. SYFOVRE became available, in the U.S., March 2023. It is under review by the European Medicines Agency for 2024 and an application has been submitted to Health Canada.
Please note: OE Patients receives no compensation from products or brands mentioned in this publication.
Post originally published Feb 28, 2023 and most recently updated Sep 12, 2023.