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GUIDANCE DOCUMENT

Neovascular Age-Related Macular Degeneration: Developing Drugs for Treatment February 2023

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2022-D-0073
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research
Center for Drug Evaluation and Research

This guidance is intended to provide recommendations to sponsors regarding eligibility criteria, trial design considerations, and efficacy endpoints to enhance clinical trial data quality and to foster greater efficiency in development programs for drugs for the treatment of neovascular age-related macular degeneration.2, 3

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All written comments should be identified with this document's docket number: FDA-2022-D-0073.

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