Apellis Pharmaceuticals (APLS) Announces Oral Presentations from Phase 3 DERBY and OAKS Studies at AAO

Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) announced that four oral presentations of data from the Phase 3 DERBY and OAKS studies evaluating pegcetacoplan for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration will be presented at the American Academy of Ophthalmology (AAO) Annual Meeting on September 30 – October 3 in Chicago, Illinois. Data highlights include detailed 24-month results of safety and efficacy as well as exploratory analyses of lesion growth data and photoreceptor changes utilizing artificial intelligence guided image processing.

“Our scientific presence at AAO this year is a testament to our leadership in retina and the potential of pegcetacoplan to become the first treatment for GA, a devastating disease that leads to irreversible vision loss,” said Federico Grossi, M.D., Ph.D., chief medical officer, Apellis. “We look forward to sharing these data with the ophthalmology community as we work toward bringing pegcetacoplan to patients with GA as quickly as possible.”

The U.S. marketing application for pegcetacoplan for GA is under Priority Review with a Prescription Drug User Fee Act (PDUFA) target action date of Nov. 26, 2022. Apellis plans to submit a marketing authorization application to the European Medicines Agency by the end of this year.

Presentation details:

• Treatment of Geographic Atrophy Secondary to AMD With Pegcetacoplan: Two-Year Outcomes from the Randomized Phase 3 DERBY and OAKS Trials – RET10 – Friday, Sept. 30 – 4:30 – 4:36 p.m. CST
• The Role of AI-Guided OCT Imaging in Geographic Atrophy – RET19 – Saturday, Oct. 1 – 3:13 – 3:19 p.m. CST
• Efficacy of Intravitreal Pegcetacoplan in GA: 24-Month Results from the Phase 3 DERBY and OAKS Trials – PA024 – Sunday, Oct. 2, 8:12 – 8:19 a.m. CST
• Safety of Intravitreal Pegcetacoplan in GA: 24-Month Results from the Phase 3 DERBY and OAKS Trials – PA069 – Sunday, Oct. 2, 4:45 – 4:52 p.m. CST

e-Poster:

• Evaluation of Patients with GA Secondary to AMD: Analysis of the Academy IRIS^® Registry – PO427

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