The US Food and Drug Administration (FDA) has issued draft guidance for industry on the development of drugs to treat neovascular or “wet” age-related macular degeneration, an eye disorder that can lead to blindness.
The draft guidance, issued on 24 February 2023, offers the agency’s recommendations for clinical trials of drugs and biologics, including eligibility criteria, trial design and efficacy endpoints. The document was developed jointly by the FDA’s Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER)…
