SYFOVRE: the only FDA approved treatment for advanced Dry Macular Degeneration

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The U.S. Food and Drug Administration recently approved SYFOVRE (pegcetacoplan), an intravitreally administered medicine for the treatment of geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD). GA is an advanced form of dry AMD that leads to vision loss due to the death of retinal cells in the macula, the part of the eye responsible for sharp, central vision. GA affects over 5 million people worldwide and currently has no approved treatment options.

SYFOVRE is the first FDA approved medication for GA and clinical trials have demonstrated its ability to slow the progression of cell death and vision loss. In two Phase 3 clinical trials, SYFOVRE showed a 16-26% decrease in the rate of GA lesion growth compared to a sham injection, depending on the lesion character and dosing schedule. SYFOVRE is administered every month, or every other month.

SYFOVRE is administered via a painless and extremely low risk eye injection into the vitreous fluid of the eye by a fellowship trained vitreoretinal specialist, similar to the standard injections for wet macular degeneration. It is important to note that eyes that do not have underlying wet macular degeneration, who receive SYFOVRE, are at higher risk of developing wet macular degeneration, which is treatable.

Until now, there were no FDA-approved treatment options for geographic atrophy, an advanced form of age-related macular degeneration that leads to irreversible vision loss. The approval of SYFOVRE provides patients with an option to slow the progression of vision loss from this condition.

Geographic Atrophy (GA; an advanced form of dry AMD) is diagnosed through a comprehensive eye exam, often combined with the use of advanced imaging techniques that allow clinicians to examine the health of retinal cells. The approval of SYFOVRE provides new hope for patients with GA and further demonstrates the promise of drug therapies targeting the underlying cellular mechanisms of AMD. SYFOVRE marks an important first step in fighting GA and continued vision loss. Patients should speak with their eye care provider to determine if they are candidates for this new treatment option.