FDA Approves Brytly Eye Drops for Relief of Eye Redness

The US FDA has approved Brytly, a nonprescription apraclonidine ophthalmic solution, for temporary relief of eye redness caused by minor irritations. The eye drops are approved for use in individuals aged 12 years and older.

"Expanding access to safe and effective nonprescription treatments is a priority for FDA," said Mike Davis, M.D., Ph.D., Director of the FDA Center for Drug Evaluation and Research (CDER). "Today's approval of Brytly gives consumers a new nonprescription option to manage eye redness conveniently and without needing to see a healthcare provider."

This approval aligns with FDA’s Public Health Pillars, which prioritize increasing access to affordable medicines. The agency is actively working to help foster conditions that encourage competition and expand the availability of nonprescription drugs.

Eye redness is a common condition most frequently caused by swollen or dilated blood vessels on the surface of the eye, which can result from minor irritations such as dryness or dust.1 Eye drops with higher concentrations of apraclonidine are available by prescription to reduce eye pressure in patients with glaucoma or who are undergoing certain types of laser eye surgery.2

Brytly is approved only for adults and children 12 years of age and older and should not be used more than two times per day.

Before using Brytly, consumers should read the full Drug Facts label. Consumers should remove contact lenses before use and wait at least 10 minutes after applying the eye drops before re-inserting contact lenses. If additional eye drops will be used, consumers should wait five minutes between applying each product. Consumers should stop using Brytly and ask a doctor if they experience eye pain, changes in vision, continued redness, or irritation or if the condition persists for more than three days or worsens.

FDA granted the nonprescription approval to Alcon.