Hope for GA Community: Apellis Top-Line Results from Phase 3 DERBY and OAKS Studies

Statement from Retina International

Global biopharmaceutical company Apellis announced top-line results for the Phase 3 DERBY and OAKS studies on Thursday, September 9th, 2021. For the Geographic Atrophy (GA). The announcement by Apellis brings great excitement and hope to those affected by this form of retinal degeneration.

GA is an advanced form of age-related macular degeneration (AMD), a leading cause of blindness. GA causes lesions that affect the central portion of the retina, known as the macula, which is responsible for central vision. GA is progressive and irreversible, leading to central visual impairment and severe irreversible loss of vision. While there are currently no available treatments for GA, Apellis plans to submit a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) in the first half of 2022. It is estimated that over 5 million people live with GA but without treatment options this may be under reported.

The DERBY and OAKS studies evaluated intravitreal pegcetacoplan, an investigational targeted C3 therapy, in 1,258 adults with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Participants in the studies received pegcetacoplan treatment monthly and every-other-month.

While DERBY did not meet the primary endpoint, OAKS succeeded, significantly reducing GA lesion growth by 22% and 16% respectively, compared to pooled sham at 12 months.

In a prespecified analysis of the primary endpoint, pegcetacoplan had a more significant effect in patients with extrafoveal lesions at baseline. This means their lesions are situated outside the fovea, the small pit-like area of the retina where visual acuity is the highest. Patients with GA typically first develop extrafoveal lesions, which later progress to the fovea, impacting central vision. In the combined studies, monthly and every-other-month treatment with pegcetacoplan decreased GA lesion growth by 26% after 12 months in patients with extrafoveal lesions, compared to 23% in pooled sham.

Pegcetacoplan was well tolerated in both Phase 3 studies. The results from these studies demonstrate the potential for Pegcetacoplan to become the first treatment for patients with GA. For the retina community, this news could be life-changing.

Franz Badura, Chair of Retina International shares the excitement of this news, “These results  bring hope to a population currently without treatment, delaying, slowing down or preventing the progression of GA is of huge benefit to those affected. We will await with interest further reporting on this data and the outcome of the FDA submission with great enthusiasm.”

 

Read the original press release from Apellis here: Apellis Announces Top-Line Results from Phase 3 DERBY and OAKS Studies in Geographic Atrophy (GA) and Plans to Submit NDA to FDA in the First Half of 2022 | Apellis Pharmaceuticals, Inc.

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