Benzinga | Nov 10, 2021 07:55AM EST

Apellis Announces Three Oral Presentations Of The Phase 3 DERBY And OAKS Data In Geographic Atrophy To Be Highlighted At The AAO Annual Meeting

Apellis Pharmaceuticals, Inc. (NASDAQ:APLS), a global biopharmaceutical company and leader in complement, today announced that data from the Phase 3 DERBY and OAKS studies will be presented as part of three oral presentations at the American Academy of Ophthalmology (AAO) Annual Meeting to be held November 12 -- 15, 2021 in New Orleans, Louisiana. The studies evaluated the efficacy and safety of intravitreal pegcetacoplan, an investigational, targeted C3 therapy, in geographic atrophy (GA) secondary to age-related macular degeneration (AMD). In the studies, monthly and every-other-month pegcetacoplan showed a clinically meaningful reduction of GA lesion growth with a favorable safety profile in a broad population.

"There is currently no treatment for the millions of people worldwide that suffer from geographic atrophy, a progressive and irreversible disease that ultimately leads to blindness," said Rishi Singh, M.D., investigator of the DERBY study and retina specialist and staff surgeon at Cleveland Clinic Florida. "The Phase 3 data to be presented at AAO continue to support pegcetacoplan's safety and efficacy profile with both monthly and every-other-month dosing and reinforce that this investigational therapy is a breakthrough for people living with GA."

Both monthly and every-other-month pegcetacoplan met the primary endpoint in OAKS, significantly reducing GA lesion growth. While narrowly missing statistical significance in DERBY, pegcetacoplan reduced GA lesion growth with both monthly and every-other-month treatment. Additionally, in both studies, pegcetacoplan demonstrated an even greater reduction in GA lesion growth in patients with extrafoveal lesions, supporting treatment with pegcetacoplan earlier in the disease progression.

Apellis plans to submit a New Drug Application (NDA) for pegcetacoplan for GA to the U.S. Food and Drug Administration (FDA) in the first half of 2022.

Presentation details:

* Treatment of Geographic Atrophy Secondary to Age-Related Macular Degeneration with Pegcetacoplan: Updates on the Randomized Phase 3 DERBY and OAKS Trials -- RET10 -- Friday, Nov. 12 -- 3:38-3:44 p.m. CT

* Dry AMD: Are We on the Verge of a Treatment? -- SYM35 -- Monday, Nov. 15 -- 9:45-11:00 a.m. CT

* Efficacy and Safety of Intravitreal Pegcetacoplan in GA: Results from the Phase 3 DERBY and OAKS Trials -- PA064 -- Monday, Nov. 15 -- 12:18-12:25 p.m. CT