Gemini Therapeutics eye drug granted US FDA fast-track designation

Gemini Therapeutics Inc. has been granted a fast-track designation from the U.S. Food and Drug Administration for GEM103, a medicine under development to treat a type of age-related macular degeneration.

Age-related macular degeneration is a disease of the retina that causes irreversible blindness in older adults. Symptoms include blurry vision, loss of night vision and loss of central vision.

Privately owned Gemini is developing GEM103 to treat dry age-related macular degeneration, which is caused by both environmental and genetic factors. This type of age-related macular degeneration affects 90% of those with the disorder.

GEM103 is being examined in a phase 2a clinical trial.

Fast-track designation is granted to speed the development and review of investigational drugs that address an unmet medical need. Companies that receive this designation are eligible for accelerated approval and priority review and more frequent engagements with the FDA to discuss the drug's development.