Feb 19, 2023

FDA Approves Apellis’ SYFOVRE™, for the Treatment of Geographic Atrophy Secondary to Age-Related Macular Degeneration (AMD)

Newly approved treatment for Geographic Atrophy by FDA

Geographic atrophy (GA) is the advanced form of dry age-related macular degeneration (AMD) which causes blindness in one million people in the United States and 5 million worldwide.

This is the first time that a treatment has been approved for this leading cause of blindness.

Apellis Pharmaceuticals, a global biopharmaceutical company, announced the U.S. Food & Drug Administration (FDA) has approved SYFOVRE™ (pegcetacoplan injection) for people with geographic atrophy (GA) secondary to age-related macular degeneration (AMD), a leading cause of devastating central vision loss in people over 55 in developed countries. The newly approved therapy is the first ever approved by the FDA for GA. SYFOVRE slowed the growth of lesions (areas of retinal cell loss) in two Phase 3 clinical trials. In the trials, known as DERBY and OAKS, the treatment was safe and its beneficial effect increased over time. More than 12,000 injections were delivered to trial participants over 24 months.

At 24 months in the OAKS trial (637 participants), monthly injections slowed GA lesion growth by 22 percent. Injections administered every other month slowed GA lesion growth by 18 percent.

At 24 months in the DERBY trial (621 participants), monthly injections slowed lesion growth by 18 percent. Injections administered every other month slowed lesion growth by 17 percent.

SYFOVRE will be delivered through an injection into the vitreous, the soft gel in the middle of the eye, once every 25 to 60 days in an eye doctor’s office. Frequency of the injections will be at the doctor’s discretion.

Apellis is reaching out to 2,160 retinal specialists in the United States to launch the treatment in the weeks ahead. SYFOVRE is expected to be available by the beginning of March through specialty distributors and specialty pharmacies nationwide. The company expects an approval decision for SYFOVRE from the European Medicines Agency (EMA) in early 2024. A marketing application has also been submitted to Health Canada.

SYFOVRE is designed to slow the progression of GA by inhibiting C3, a protein in the complement system. While complement is part of the human immune system that wards off harmful bacteria and viruses, it can cause damage if not controlled properly. Researchers have strong evidence that an overactive complement system is involved in the death of retinal cells in AMD.

GA lesions are the regions in the retina where degeneration from dry AMD has occurred. The fovea is a small pit in the center of the retina, rich in cone photoreceptors, that provides the sharpest vision, including the ability to read and recognize faces. GA lesions often first develop outside of the fovea — these are known as extrafoveal lesions. Over time, the lesions encroach on the foveal region leading to more significant vision loss. Experts believe that targeting extrafoveal lesions with treatments before they affect the fovea may be the optimal strategy for preserving vision in people with GA. If you have geographic atrophy (GA) associated with dry AMD, consult your retinal specialist to determine if SYFOVRE is appropriate for you.

Apellis Pharmaceuticals is a corporate partner of the Macular Degeneration Association.

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