FDA approves Brytly eye drops for ocular redness relief lasting up to 12 hours

Alcon has received FDA approval for apraclonidine ophthalmic solution 0.125% (Alcon; Brytly) redness relief eye drops, an OTC ocular treatment.^1,2 The product is marketed as providing up to 12 hours of whitening effect per dose.

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

Background and safety

Eye redness most often results from swollen or dilated blood vessels on the ocular surface, which can be caused by minor irritants such as dryness or dust, according to the FDA.² Higher concentrations of apraclonidine are already available by prescription to lower pressure in patients with glaucoma or in patients undergoing certain laser eye procedures.²

Brytly is approved for adults and children aged 12 years and older and should not be used more than twice a day.^1,2 Patients should remove contact lenses before use and wait at least 10 minutes after instillation before reinserting them. Additionally, when using other eye drops, patients should wait 5 minutes between products.² The FDA advises patients to stop using Brytly and consult a doctor if they experience eye pain, changes in vision, continued redness or irritation, or if the condition worsens or persists for more than 3 days.² According to Alcon, Brytly contains no bleaches or dyes.¹ The company reported a low risk of rebound redness and tachyphylaxis when the drop is used as directed, citing internal data on file.¹ Alcon did not release clinical trial results with the announcement.

Takeaways from eye care providers

Patients asking about whitening drops will need counseling on contact lens timing, spacing with other drops, and when persistent redness warrants an examination.² “When patients ask about eye whiteners, they want a product they can trust to work effectively and fit into their day,” Selina McGee, OD, FAAO, DipABO, founder and chief optometrist of Bespoke Vision, noted. “Brytly gives eye care professionals a clinically proven option to recommend, with demonstrated safety and efficacy and long-lasting redness reduction from a single drop.”

This content was generated with the assistance of AI.

References

1. FDA approves Alcon’s BRYTLY redness reliever eye drops for up to 12 hours of whiter, brighter-looking eyes. News release. Alcon, Inc. Published October 16, 2026. Accessed October 19, 2026. https://www.businesswire.com/news/home/20261016098063/en/FDA-Approves-Alcons-BRYTLY-Redness-Reliever-Eye-Drops-for-Up-to-12-Hours-of-Whiter-Brighter-Looking-Eyes

2. FDA approves new nonprescription eye drop for relief of eye redness. News release. FDA. Published October 16, 2026. Accessed October 19, 2026. https://www.fda.gov/drugs/drug-alerts-and-statements/fda-approves-new-nonprescription-eye-drop-relief-eye-redness