The US Food and Drug Administration (FDA) has approved Brytly (apraclonidine ophthalmic solution; Alcon) 0.125%, a new nonprescription eye drop for the relief of eye redness caused by minor irritations. Brytly is the first apraclonidine-containing eye drop that has been approved for over-the-counter (OTC) use. Apraclonidine is also available in higher concentrations as a prescription ophthalmic medication to reduce intraocular pressure in patients with glaucoma or those undergoing certain laser eye procedures such as trabeculoplasty, Nd: YAG iridotomy, and capsulotomy.

Brytly is approved for adults and children ages 12 years and older and should not be used more than twice daily.

The FDA outlined several precautions for using the product. Contact lens wearers should remove their lenses before administration and wait at least 10 minutes before reinserting them. Patients using additional ophthalmic drops should allow at least 5 minutes between applications. Consumers are instructed to discontinue use and consult a physician if they experience eye pain, changes in vision, persistent redness or irritation, or if their condition worsens or continues for more than 3 days. The FDA advised consumers to review the complete Drug Facts label before using Brytly.

“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 (CDER) in a press release. “Today's approval of Brytly gives consumers a new nonprescription option to manage eye redness conveniently and without needing to see a health care provider.”