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FDA Grants Apellis FTD

For APL-2, a novel inhibitor of complement factor C3 as a next generation monotherapy for the treatment of geographic atrophy

Apellis Pharmaceuticals announced that the FDA has granted Fast Track designation to the Company’s APL-2, a novel inhibitor of complement factor C3 as a next generation monotherapy, for the treatment of patients with geographic atrophy (GA), an advanced form of age-related macular degeneration.


The FDA’s Fast Track program facilitates the development and expedites the review of drugs to treat serious conditions and fill an unmet medical need, allowing important new drugs to reach the patient earlier. 

“The Fast Track designation represents an important recognition by the FDA of APL-2’s potential to treat geographic atrophy, a blinding disease for which there is no treatment,” commented Cedric Francois, MD, PhD, founder and chief executive officer of Apellis. “The severe vision loss associated with GA makes it difficult for patients to recognize faces, read, drive a car and go about their daily lives, limiting quality of life.  We believe that by slowing down the rate of degeneration through broad C3 inhibition, we may be able to improve outcomes for these patients.”

Apellis plans to initiate a Phase 3 trial for patients with GA later this year which will consist of two identical, prospective, multicenter, randomized, double-masked, sham-injection controlled studies to assess the efficacy and safety of multiple intravitreal (IVT) injections of APL-2 in patients with GA.

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