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FDA gives nod for Apellis’ injection to treat geographic atrophy

Apellis Pharmaceuticals, a US-based biopharmaceutical company, has got FDA approval for a drug to treat geographic atrophy, the company announced.

HQ Team

February 20, 2023: Apellis Pharmaceuticals, a US-based biopharmaceutical company, has got FDA approval for a drug to treat geographic atrophy, the company announced.

The Syfovre injection, which the company claims are the first and only FDA-approved treatment for geographic atrophy, fights blindness caused by the disease.

Geographic atrophy (GA) is an advanced form of age-related macular degeneration that can significantly impact visual function but has no approved treatment.

It is a progressive and irreversible disease caused by the growth of lesions, which destroy the retinal cells responsible for vision. The vision loss caused by GA severely impairs independence and quality of life by making it difficult to participate in daily activities.

On average, it takes only 2.5 years for GA lesions to start impacting the fovea, which is responsible for central vision.

The disease impacts more than one million people in the US and five million worldwide.

24-month study

The approval of Syfovre was based on positive results from the Phase 3 OAKS and DERBY studies for 24 months across a broad and representative population of patients.

Syfovre is approved for atrophy patients with or without subfoveal involvement and provides dosing flexibility for patients and physicians with a dosing regimen of every 25 to 60 days.

In the studies, the medicine cut the rate of GA lesion growth compared to other treatment effects over time.

Eleonora Lad, M.D., PhD, lead investigator for the OAKS study, director of ophthalmology clinical research, and associate professor of ophthalmology at Duke University Medical Center said currently, there had been no approved therapies to offer people living with geographic atrophy.

Their vision “relentlessly declined. With Syfovre, we finally have a safe and effective geographical atrophy (GA) treatment for this devastating disease, with increasing effects over time.”

US availability in March

With the medicine’s “flexible dosing”, Syfovre it will make a meaningful difference in the lives of people with GA” said Cedric Francois, MD, PhD, co-founder and chief executive officer of Apellis. “GA is a complex disease that the field has spent decades trying to address, so we are humbled and proud to bring forward the first-ever treatment.”

The injection may be available by March through speciality distributors and speciality pharmacies in the US. A marketing authorisation application for Syfovre is under review by the European Medicines Agency, and a decision is expected in early 2024.

A marketing application has been submitted to Health Canada.

“For the first time, we are celebrating the approval of a treatment for GA,” said Jeff Todd, president and chief executive officer of Prevent blindness. “This is a historic and hopeful day for all GA patients and their care partners, who have been waiting for treatment for this relentless form of vision loss.”

Syfovre’s safety was tested by injecting more than 12,000 patients. The most common adverse reactions, greater than five per cent, were reported in patients: ocular discomfort, neovascular AMD, vitreous floaters, and conjunctival haemorrhage.

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