What is Syfovre?
Syfovre (pegcetacoplan) is a new medication approved by the FDA in February 2023 for the treatment of geographic atrophy caused by dry-type age related macular degeneration (AMD). It is given by injection into the eye.
What is geographic atrophy?
Geographic atrophy (GA) is a common cause of loss of central vision in AMD. It occurs when retinal receptor cells die. As a result, GA leaves blinds spots and missing areas in the vision. Until now, there was no treatment for geographic atrophy from AMD.
How does Syfovre work?
Syforvre blocks the complement proteins in the body. Complement proteins regulate the normal inflammatory response of the body. The inflammatory response is important to fight infection. However, in AMD the complement proteins appear to cause harm, as they contribute to the development of geographic atrophy and loss of vision.
How well does Syfovre work?
Syfovre is not a cure for dry AMD. Syfovre does not reverse the past damage by geographic atrophy and does not keep it from getting worse. However, Syfovre, when given by monthly injection, slows the rate of worsening of geographic atrophy by 19-22% over two years as compared with sham injection. There was no measured benefit in visual acuity or visual function during the two-year study, perhaps because it would take longer for the benefits to be measured.
What are the adverse effects of Syfovre?
As with all intraocular injections there are risks. The risks involved with the introduction of a needle into the eye include bleeding, infection, and retinal detachment. These complications may require surgery, and they risk loss of vision. The known risks of Syfovre include the new development of wet AMD with blood vessel growth threatening loss of vision. In the phase 2 study, wet AMD developed in 20.9% of eye treated with Syfovre compared with 1.2% in eye with sham injection. This represents a 1,742% increased risk. Post hoc analysis suggests the risk of new wet AMD from Syfovre may be reduced by avoiding treatment in high-risk eyes. It is important to avert the development of new wet AMD because the treatment of wet AMD involves routine, long-term injection of antiVEGF medications to prevent severe loss of vision.
There is risk of infection (endophthalmitis) after eye injections The rate of infection with Syfovre was 1-2%…much higher than the rate of infection with other medications given by injection. This increased risk may be explained by the suppression of the natural immune defense by Syfovre. There is also a 1.7% risk of ischemic optic neuropathy. This is an unusual complication among the various drugs used for injection into the eye.
The decision to use Syfovre with the intent to slow the progression of dry AMD (geographic atrophy) must be weighed against the potential adverse effects in any given patient.
NOTE: As of August 19, 2023 the Syfovre phase 3 study results have not been published or available for review by prescribing physicians. These studies provided the basis on which the FDA gave approval for marketing Syfovre in the US.
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