FDA & Tech Innovation

The Academy strongly supports biomedical innovation and efforts to advance treatments quickly and safely — from early-stage research through U.S. Food and Drug Administration (FDA) approval. We believe patients with serious eye conditions deserve timely access to new therapies and technologies, and that the regulatory environment should facilitate, not impede, that access.

This includes supporting appropriate FDA pathways for new drug approvals, medical devices, artificial intelligence-based diagnostic tools, and emerging areas such as gene therapy for inherited retinal diseases. The Academy also believes that innovation must be paired with equitable access — so that new technologies benefit all patients, not just those with access to specialized care.

The Academy closely monitors legislative and regulatory proposals affecting the biomedical research enterprise and the drug and device approval process, working with members of Congress and FDA officials to provide input where it matters most for ophthalmology.

Key areas of current focus include:

Artificial intelligence

Ophthalmology is at the forefront of AI-enabled diagnostics. The Academy has established a dedicated Committee on Artificial Intelligence, created in 2021, to guide members through the technical, ethical, and clinical dimensions of AI in ophthalmic practice. The Academy has also partnered with the American College of Radiology to expand the ACR's AI-LAB platform to include eye care, giving ophthalmologists access to real-world AI use cases and datasets.

Gene therapy

Inherited retinal diseases represent one of the most promising frontiers for gene therapy. The FDA approval of Luxturna (voretigene neparvovec) for RPE65-mediated retinal dystrophy was a landmark milestone, and a growing pipeline of new therapies is now moving through clinical trials. The Academy monitors and supports appropriate regulatory pathways for these treatments.

Drug and device innovation

The Academy engages with the FDA on ophthalmic drug and device approval processes, including through direct collaboration on issues such as clinical trial endpoint development.  

The pace of innovation in ophthalmology has accelerated dramatically in recent years. The FDA approved 12 new ophthalmic drugs and devices in 2023 alone — including the first treatments for geographic atrophy secondary to age-related macular degeneration, a condition that previously had no approved therapies. In 2024, the FDA cleared the first home optical coherence tomography (OCT) device and authorized autonomous artificial intelligence tools for portable diabetic retinopathy screening.

Several federal policy efforts have shaped the environment for this innovation. The FDA Safety and Innovation Act of 2012 reauthorized key funding sources and updated policies to accelerate the review process. The 21st Century Cures Act, signed into law in December 2016, went further — providing new funding for the National Institutes of Health, modernizing clinical trial design, and creating new FDA approval pathways for drugs and devices. These reforms have had direct benefits for ophthalmology, enabling faster progress on treatments for conditions such as macular degeneration, diabetic retinopathy, glaucoma, and inherited retinal diseases.

Looking ahead, artificial intelligence and gene therapy represent two of the most consequential frontiers for ophthalmic innovation. AI-enabled diagnostic tools are already FDA-cleared for autonomous diabetic retinopathy screening, and the technology is rapidly expanding to other conditions. Gene therapies targeting inherited retinal diseases are advancing through clinical trials, with mutation-agnostic approaches potentially broadening treatment to a wider range of patients than early therapies could reach.