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FDA Approves First Treatment for Advanced Dry AMD

Fda Approves First Treatment for Advanced Dry Amd

Monumental Moment for Retinal Care

Patients and doctors across the country are celebrating a monumental moment in the history of retinal care:  the first treatment for advanced dry AMD (geographic atrophy) has been FDA-approved.

Nearly 1.5 million Americans and over 5 million people worldwide suffer from advanced dry AMD, a leading cause of irreversible blindness and a condition that, until now, had no FDA-approved treatment. Dry AMD occurs when the light-sensitive cells in the macula break down over time, leading to a gradual loss of central vision. In advanced dry AMD, this damage has progressed significantly. There may be substantial thinning of the macula or the formation of abnormal blood vessels under the retina, leading to further vision loss. With no treatment until now, patients were limited to mere supportive measures, such as vitamins and lifestyle changes.

FDA Approves Intraocular Injections for Advanced Dry AMD

That all changed on February 17, 2023, when the FDA approved Apellis Pharmaceuticals’ SYFOVRE, a pegcetacoplan injection to treat geographic atrophy. SYFOVRE is an inhibitor that blocks the complement proteins from activating and initiating inflammatory responses. When the body faces infection, the complement system, comprised of plasma proteins, induces inflammatory responses which act to remove adverse stimuli. Despite complement proteins’ critical role in fighting infections, they also increase tissue damage that can contribute to worsening GA. Hence why SYFOVRE is designed to target these proteins and inhibit them.

The approval of SYFOVRE is the most important event in retinal ophthalmology in more than a decade,” said Eleonora Lad, M.D., Ph.D., lead investigator for the OAKS study, director of ophthalmology clinical research, associate professor of ophthalmology, Duke University Medical Center. “Until now, there have been no approved therapies to offer people living with GA as their vision relentlessly declined. With SYFOVRE, we finally have a safe and effective GA treatment for this devastating disease, with increasing effects over time.”

36% Reduction In Lesion Growth Reported

SYFOVRE has been well tested, receiving positive results from two Phase 3 studies, OAKS and DERBY, in 24 months. Through monthly and bi-monthly pegcetacoplan injections, the studies demonstrated a meaningful reduction of lesion growth in patients with advanced dry AMD. The study also saw increasing positive effects over time, seeing the most improvement between months 18-24 with a 36% reduction in lesion growth for the monthly treatment in the DERBY trial.

“The fact that the drug works better over time means it has a positive effect, and the patients should have the hope that they’re preventing retinal degeneration more as they take the drug over longer time intervals,” Eleonora Lad said.

A New Door Opens

Like any intraocular injection, SYFOVRE is not without risks. Some known risks include the new development of wet AMD and the risk of infection at a higher rate (1-2%) than the rate of infections after other injections. 

While patients and doctors must weigh the benefits against the adverse effects, it is still clear that SYFOVRE has opened a new door for a patient population that has faced nothing but closed doors until now.

SYFOVRE has already begun hitting markets, and it is currently available through specialty distributors and pharmacies nationwide, costing $2,190 per vial.