New FDA Approval: SYFOVRE
We are excited to announce a significant advancement in the treatment of geographic atrophy (GA), an advanced form of age-related macular degeneration (AMD) and a leading cause of blindness. The U.S. Food and Drug Administration (FDA) has recently approved SYFOVRE™ (pegcetacoplan injection), the first and only therapy specifically for GA. This approval marks a historic milestone in retinal ophthalmology and offers new hope to those affected by this condition.
Geographic atrophy is a progressive and irreversible disease characterized by the growth of lesions that destroy retinal cells responsible for vision. This loss of vision significantly impairs daily activities and quality of life. Until now, there have been no approved treatments for GA, making this development particularly impactful.
SYFOVRE works by targeting C3, a protein in the complement system, which is believed to play a role in the death of retinal cells in AMD. In the OAKS and DERBY Phase 3 clinical trials, SYFOVRE demonstrated a slowing in the growth of GA lesions. At 24 months, monthly injections of SYFOVRE reduced GA lesion growth by 22% in the OAKS trial and 18% in the DERBY trial. For injections administered every-other-month, the reduction rates were 18% and 17%, respectively.
However, it’s important to be aware of the potential risks associated with SYFOVRE. The most common adverse reactions observed in patients were ocular discomfort, neovascular AMD, vitreous floaters, and conjunctival hemorrhage. Additionally, patients should be cautious of eye infections, retinal detachments, and increased intraocular pressure following injections. It is crucial to monitor for these symptoms and seek medical attention if they occur.
SYFOVRE is administered via intravitreal injection and is expected to be available through specialty distributors and pharmacies. Apellis Pharmaceuticals, the developer of SYFOVRE, also offers ApellisAssist®, a support program for patients and healthcare providers, which includes insurance support and disease education.
For patients of Compton Eye Associates, the availability of SYFOVRE opens up a new avenue for the management of GA. We encourage those affected by GA or AMD to consult with our healthcare professionals to discuss whether SYFOVRE is an appropriate treatment option for their specific condition.
To learn more about SYFOVRE and its potential benefits and risks, or to explore treatment options for geographic atrophy, we welcome you to schedule an appointment at our office. Our dedicated team is here to provide the latest and most effective treatments, ensuring the best possible care for your eye health.