Newest Sustained-Release Anti-VEGF Drug in Trials
EyePoint Pharmaceuticals, Inc. announced on January 28, 2021 that the first patient has been dosed in their Phase 1 clinical trial of EYP-1901. EYP-1901 is a potential twice-yearly sustained delivery intravitreal anti-VEGF treatment for wet age-related macular degeneration (wAMD). It is the newest of several sustained delivery drugs under study, this one promising to extend treatments from 4-6 weeks to only twice a year.
Faricimab for Wet AMD Effective at 16-week Intervals
Genentech has announced positive topline results from its Phase III studies, TENAYA and LUCERNE, evaluating its new drug faricimab for people with wet (neovascular) age-related macular degeneration (nAMD). Both studies have shown that people receiving faricimab injections at fixed intervals of up to every 16 weeks achieved visual acuity outcomes as effective as those receiving injections every 4-6 weeks.
Zimura Shows Significant Suppression of GA
(late stage dry macular degeneration)
IVERIC bio, Inc. has announced positive Phase 3 results from its GATHER1 clinical trial with Zimura (avacincaptad pegol). Zimura® inhibits complement factor C5, which is believed to be involved in the development of AMD. The reduction in the mean rate of geographic atrophy (GA) growth over 12 months was better than 27% group as compared to sham control groups. The data was statistically significant, and the drug was generally well tolerated. GATHER2 is currently underway to further evaluate the efficacy and safety of Zimura in patients with GA.
Lucentis Substitute In Phase 3 Trials
Samsung Bioepis is reporting first year results from their phase 3 study of a proposed lucentis biosimilar (SB11). A biosimilar is a biological product (derived from a living organism) that shows no clinically meaningful differences from another biologic (eg. Lucentis). This study has shown that, at 52 weeks, primary end points were met for visual acuity and retinal health, suggesting that it could become a substitute for Genentech’s Lucentis (ranabizumab). This would be the first biosimilar for an anti-VEGF drug, which could lead to significant cost savings for the U.S. health system and consumers.
APL-2 Slows Progression of Early Disease in Patients with Geographic Atrophy
Apellis Pharmaceuticals,Inc. announced their analysis of the Phase 2 FILLY study investigating intravitreal pegcetacoplan (APL-2) for the treatment of geographic atrophy (GA), also known as advanced dry macular degeneration. The post hoc analysis found that the monthly treatment reduced the rate of progression to GA by 39 percent in areas of the retina outside of existing GA lesions.
APL-2 is the only targeted C3 therapy in Phase 3 clinical trials for GA, which affects approximately five million people globally and has no approved treatment. According to SriniVas Sadda, M.D., President & Chief Scientific Officer of the Doheny Eye Institute and lead investigator, “This study provides exciting evidence to support further exploration of the potential of pegcetacoplan for earlier intervention in the course of GA.”