Apellis Pharmaceuticals, Inc. announced that The Lancet published the positive 24-month results from the Phase 3 OAKS and DERBY studies evaluating SYFOVRE®? (pegcetacoplan injection) for geographic atrophy (GA) secondary to age-related macular degeneration (AMD). SYFOVRE is the only treatment approved for use beyond 12 months in GA, a chronic disease and leading cause of vision loss.

In the publication, both every-other-month and monthly SYFOVRE showed a clinically meaningful reduction of GA lesion growth with increasing effects over time and a well-demonstrated safety profile in a broad population of more than 1,200 patients. SYFOVRE is approved in the United States for the treatment of GA secondary to age- related macular degeneration. Marketing applications are currently under review with five regulatory agencies worldwide.

A decision in the EU is expected in early 2024, and decisions in Canada, Australia, Switzerland, and the United Kingdom are expected in the first half of 2024. U.S. Important Safety Information for SYFOVRE®?. SYFOVRE is contraindicated in patients with ocular or periocular infections, and in patients with active intraocular inflammation; and Endophthalmitis and Retinal Detachments: Intravitreal injections, including those with SYFOVRE, may be associated with endophthalmitis and retinaldetachments.

Proper aseptic injection technique must always be used when administering SYFOVRE to minimize the risk of endophthalmitis or retinal detachment without delay and should be managed appropriately. Neovascular AMD: In clinical trials, use of SYFOVRE was associated with increased rates of neovascular (wet) AMD or choroidal neovascularization (12% when administered monthly, 7% when administered every other month and 3% in the control group) by Month 24. Patients receiving SYFOVRE should be monitored for signs of neovascular AMD.

In case anti-Vascular Endothelial Growth Factor (anti-VEGF) is required, it should be given separately from SYFOVRE administration. Intraocular Inflammation: In clinical trials, use the SYFOVRE was associated With episodes of intraocular inflammation including: vitritis, vitreal cells, iridocyclitis, uveitis, anterior chamber cells, iritis, and anterior chamber flare. After inflammation resolves, patients may resume treatment with SYFOVRE.

Increased Intraocular Pressure: Acute increase in IOP may occur within minutes of any intravitreal injection, including with SYFOVRE. Perfusion of the optic nerve head should be monitored following the injection and managed as needed. ADVERSE REACTIONS: Most common common treatment of GA, which is expected to be used in the United States and five additional applications under review globally, the company is working urgently to bring this important treatment to patients in need worldwide.