Medications for Dry Macular Degeneration Available in the USA Not Yet Approved in Europe

With Pegcetacoplan (Syfovre(R)) from Apellis Pharmaceuticals and Avacincaptad pegol (Izervay(R)) from Astellas Pharma, two innovative therapies for the treatment of geographic atrophy (GA) in age-related dry macular degeneration (AMD) are already approved in the USA, but not yet authorized by the European Medicines Agency (EMA). In the USA, both medications were approved by the Food and Drug Administration (FDA) due to positive study results showing their efficacy in slowing the progression of GA. Pegcetacoplan works by inhibiting complement factor C3, while Avacincaptad pegol targets complement factor C5. Both approaches aim to slow progressive vision loss due to the loss of photoreceptor cells in the macula. In Europe, however, patients and doctors are still awaiting official approval of these treatments by the EMA. Although the effect of both intravitreally injected drugs was recognized, and their delaying effect on the progression of atrophy confirmed, the EMA did not see a clinically significant benefit that would justify the potential risks of the treatment. Apellis Pharmaceuticals has requested a re-examination, and the final decision is expected in the fourth quarter of 2024. Until then, supplementation with AREDS2-compliant preparations remains the glimmer of hope for patients with dry geographic macular degeneration to preserve their vision.

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