Syfovre FDA Approval History
Last updated by Judith Stewart, BPharm on Feb 21, 2023.
FDA Approved: Yes (First approved February 17, 2023)
Brand name: Syfovre
Generic name: pegcetacoplan
Dosage form: Injection
Company: Apellis Pharmaceuticals, Inc.
Treatment for: Macular Degeneration
Syfovre (pegcetacoplan) is a complement inhibitor indicated for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
- Geographic atrophy (GA) is an advanced form of dry age-related macular degeneration (AMD) and is a leading cause of blindness. In GA, cell death in areas of the retina experience may result in dim or dark spots in the central vision.
- Syfovre works by inhibiting C3, a protein in the complement system. An overactive complement system is thought to be involved 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 lesions (areas of retinal cell loss).
- 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 is administered via intravitreal injection once every 25 to 60 days.
- Warnings and precautions associated with Syfovre include endophthalmitis and retinal detachments, neovascular AMD, intraocular inflammation, and increased intraocular pressure. Patients should seek immediate care from an ophthalmologist if the affected eye becomes red, sensitive to light, painful, or if there is any change in vision such as flashing lights, blurred vision or metamorphopsia (straight lines appear warped).
- Common adverse reactions include ocular discomfort, neovascular age-related macular degeneration, vitreous floaters, and conjunctival hemorrhage.
Development timeline for Syfovre
Further information
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