On February 17, 2023, during AMD / Low Vision Awareness Month, the United States Federal Drug Administration (FDA) approved the first treatment ever for advanced dry age-related macular degeneration, also referred to as geographic atrophy (GA). In clinical trials, the drug, SYFOVRE, slowed progressing GA with an increase in effect over the course of treatment. The drug from Appelis 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. The most common adverse reactions were affected; about 5% of patients were ocular discomfort, floaters and conjunctivial hemorrhage.
Advanced dry-AMD or GA affects 1 million people in the U.S. and 5 million worldwide. It is a continuation of the dry 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.
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.
SYFOVRE availability will begin as early as March 2023 in the US, and it is under review by the European Medicines Agency for 2024 and an application has been submitted to Health Canada.
Patients and healthcare providers can call Appelis Assist at 888-273-5547 for treatment access and support.
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