The Safety of Recently Approved Therapeutics in Age-Related Macular Degeneration

Recent developments in treatments for both forms of advanced age-related macular degeneration (AMD) have led to the approval of multiple agents and modalities within the last few years. Five new medications for both neovascular AMD (nAMD) and geographic atrophy (GA) secondary to nonexudative AMD (neAMD) have been FDA-approved within the last 5 years, along with a new device designed for sustained drug delivery for nAMD. In nAMD, the newest agents approved by the FDA are brolucizumab (Novartis Pharmaceuticals, Basel, Switzerland), faricimab (F. Hoffman-La Roche, Basel, Switzerland), aflibercept 8 mg (Regeneron Pharmaceuticals, Tarrytown, NY, USA), and a new device in the port delivery system with ranibizumab (Genentech, San Francisco, CA, USA). The first agents FDA-approved for GA secondary to neAMD are pegcetacoplan (Apellis Pharmaceuticals, Waltham, MA, USA) and avacincaptad pegol (Iveric Bio, Parsippany, NJ, USA). Evaluation of safety in both clinical trials and the real-world has been of paramount importance after the approval of these newest agents to understand their effects in real patients. Real-world data, as demonstrated in both registrational studies along with retrospective chart review studies, has shown to be an important factor in the implementation of newer drugs, along with the treatment decisions that physicians choose to make regarding their dosing and follow-up. This review article discusses the safety of the most recently approved FDA as seen in both clinical trials and real-world studies.