Retina Society 2023: Routine Clinical Practice Use and Postmarketing Safety of Pegcetacoplan for Geographic Atrophy Secondary to Age-Related Macular Degeneration in the United States

Prashanth G. Iyer, MD, MPH
Tufts Medical Center/Ophthalmic Consultants of Boston

Dr. Nathan Steinle started this presentation by stating that there have been approximately 24,000 injections of pegcetacoplan administered from clinical trials to date as well as >100,000 vials distributed in the US for real-world clinical use. With time, there seems to be an increasing effect of pegcetacoplan with GA growth being 39% less for the treatment arm compared to sham over 24-30 months.

A large focus of this talk surrounded post-injection vasculitis. Dr. Steinle reported a ~0.01% rate of occlusive retinal vasculitis with real world use of pegcetacoplan. As of October 4, 2023, there have been 10 cases and 2 suspected cases of retinal vasculitis. Of those vasculitis cases, the majority have had either partial or full recovery of visual acuity, with a subset of patients having severe vision loss. All of these events occurred after the first injection with onset between 8-18 days (median of 11 days). The presentation of vasculitis varied from mild to severe.

There has been much oversight including monitoring commercial lots, reviewing the clinical program and evaluating the drug preparation and administration. One of the differences between the trial and real world administration was the use of 19-g filtering needles as opposed to 18-g filtering needles. Out of caution, the 19-g needle was removed from circulation, although no causal relationship was found between vasculitis and the 19-g filter needle. Other considerations that were suggested included allowing sufficient time for the product to reach room temperature, confirming the correct filtering needle, drawing up the medication into the syringe slowly, and performing decompression of the eye prior to injections.

Dr. Steinle explained that when faced with a case of vasculitis, it is important to do a tap and inject first to rule out infectious causes, and then to start aggressive steroids.