OTC Alpha-Agonist Drops for Eye Redness Get FDA Green Light

The FDA announced approval of apraclonidine ophthalmic solution 0.125% (Brytly) as an over-the-counter treatment for eye redness related to minor irritations.

The approval specifies use of the topical agent by adults and children 12 or older. In the announcement, the agency noted that the approval provides consumers with the first nonprescription apraclonidine formulation. A prescription-strength formulation of the alpha-adrenergic agonist was approved for prevention of postoperative spikes in intraocular pressure.

“Expanding access to safe and effective nonprescription treatments is a priority for FDA,” said Mike Davis, MD, PhD, director of the FDA’s Center for Drug Evaluation and Research. “Today’s approval of Brytly gives consumers a new nonprescription option to manage eye redness conveniently and without needing to see a healthcare provider.”

The agency noted that eye redness is a common condition, typically resulting from minor irritations such as eye dryness or exposure to dust.

The approval stipulates a maximum of two applications of the eye drops in one day. People who wear contact lenses should remove the lenses before application and wait at least 10 minutes before reinserting them. When using multiple eye drops, patients should wait at least 5 minutes between applications to prevent drug washout.

Packaging for the eye drops says people should not use if the product becomes cloudy and says to stop use and contact a doctor if eye pain, changes in vision, or redness persists for more than 3 days or becomes worse.

FDA granted the license to Alcon.