Safety of Recent Ophthalmic Drugs and Devices for Wet AMD

Abstract and Introduction

Abstract

Purpose of Review: With frequent antivascular endothelial growth factors (VEGF) injections well established as the standard of care in neovascular age-related macular degeneration (nAMD), focus has now shifted towards decreasing treatment burden without compromising safety and efficacy. This review summarizes clinical stage and recently approved drugs and devices for nAMD, with an emphasis paid to safety concerns and their implications for product adoption.

Recent Findings: Three strategies have emerged to decrease the treatment burden associated with the current standard of care: more durable intravitreal agents, sustained-release modalities and gene therapy. The appearance of biosimilars will further impact drug availability and cost. As patterns of adverse events emerge from clinical trial or postmarketing surveillance data, manufacturers have proactively responded by appointing independent review committees or issuing voluntary recalls. However, the example of one biosimilar approved outside of the USA and European Union demonstrates how early safety concerns, even when addressed by substantive data, can generate lingering uncertainty.

Summary: As the number of promising new treatments in nAMD continues to grow, so too does the amount of data that providers must sift through. The perception of safety surrounding first movers in each new therapeutic area is sure to affect adoption of that modality more broadly.

Introduction

Despite mounting evidence that frequent antivascular endothelial growth factor (VEGF) injections lead to improved and sustained visual acuity outcomes in neovascular age-related macular degeneration (nAMD), real-world outcomes fall short due to the high treatment burden and need for regular monitoring. Innovative paths towards decreasing treatment burden, while maintaining or improving on the safety and efficacy of the current standard of care, have emerged. These include more durable intravitreal agents, sustained-release modalities and gene therapy. This review will cover recently approved ophthalmic drugs and devices that treat nAMD, with an emphasis on safety.