SYFOVRE® (pegcetacoplan injection) Continued to Demonstrate Increasing Treatment… – Press Release

• SYFOVRE reduced nonsubfoveal GA lesion growth by up to 45% between Months 24-30 compared to projected sham in the GALE long-term extension study
• Safety profile of SYFOVRE in GALE was consistent with previously reported clinical data
• Data presented during an oral presentation at the American Society of Retina Specialists (ASRS) Annual Scientific Meeting

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WALTHAM, Mass., July 30, 2023 (GLOBE NEWSWIRE) — Apellis Pharmaceuticals, Inc. APLS today announced data from the GALE extension study following 30 months of continuous treatment with SYFOVRE^® (pegcetacoplan injection), the first and only FDA approved treatment for geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The data, which reinforce the long-term efficacy and safety of SYFOVRE, were reported during an oral presentation at the American Society of Retina Specialists (ASRS) Annual Scientific Meeting.

“The GALE results show that SYFOVRE continues to demonstrate robust and increasing effects through 30 months with both monthly and every-other-month treatment,” said Caroline Baumal, M.D., chief medical officer, Apellis. “We are especially excited by the data showing that SYFOVRE reduced GA lesion growth by up to 45% in patients with nonsubfoveal lesions.”

In GALE, SYFOVRE reduced GA lesion growth with both monthly (39%; p<0.0001) and every-other-month (EOM) (32%; p<0.0001) treatment between Months 24 and 30 compared to the projected sham arm (all p-values nominal).

Additionally, SYFOVRE reduced nonsubfoveal GA lesion growth with monthly (45%; p<0.0001) and EOM (33%; p=0.0023) treatment between Months 24 and 30 compared to the projected sham arm.

“These positive long-term results deepen our understanding of SYFOVRE as a meaningful therapy for this progressive and irreversible disease, adding to the most robust dataset ever collected in GA,” said Nathan Steinle, M.D., presenting author,…

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