FDA Approves Alcon's Brytly, First Over-the-Counter Apraclonidine Eye Drop for Redness

The FDA approved Alcon's Brytly on Friday, Oct. 16, 2026, as an over-the-counter treatment for eye redness caused by minor irritations. It is the first nonprescription eye drop containing apraclonidine.

The active ingredient is not new. Until now, apraclonidine was available only by prescription, in higher concentrations, to reduce eye pressure in glaucoma patients and to prevent pressure spikes after certain laser eye procedures. Brytly is a 0.125% solution.

What the label says

Brytly is approved for adults and children 12 and older. Users may apply it no more than twice a day.

Contact lens wearers must remove their lenses first and wait at least 10 minutes before putting them back in. Anyone using other eye drops should wait five minutes between products.

The label tells users to stop and ask a doctor if they develop eye pain or vision changes, or if redness continues for more than three days or gets worse.

The FDA noted that eye redness is common and usually comes from swollen or dilated blood vessels on the surface of the eye, triggered by things like dryness or dust.

How it works

Apraclonidine is an alpha-2 adrenergic agonist. For redness, it binds to receptors on the small blood vessels on the eye's surface, narrowing them. The prescription versions lower eye pressure by reducing fluid production inside the eye.

The prescription product, Iopidine 1%, carries monitoring requirements for side effects. Those include eyelid elevation, irregular heartbeat, inflammation, dizziness and drug interactions. The OTC version uses a much lower dose aimed at a single purpose.

The FDA's case

"Expanding access to safe and effective nonprescription treatments is a priority for FDA," said Mike Davis, M.D., Ph.D., 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 tied the decision to its "Public Health Pillars," which prioritize affordable medicines. It said it is working to foster competition and expand nonprescription drug availability.

Alcon's pitch against Lumify

Alcon is going straight at the category leader. The company says one drop gives up to 12 hours of redness relief, up to 50% longer than Bausch + Lomb's Lumify, which uses brimonidine tartrate.

Alcon also says studies associate Brytly with a low risk of rebound redness and tachyphylaxis, meaning the drug losing effectiveness with repeated use. Those are company claims. The FDA's announcement does not make a head-to-head comparison with Lumify.

Alcon said it expects Brytly to reach retail shelves and online stores in the coming months, with later expansion into other markets. It has not disclosed a price or a launch date.

The limits of self-treatment

The convenience cuts both ways. Redness can signal conditions that need a doctor's evaluation, and persistent or worsening redness may point to something more serious than dust or dry air. The label's three-day cutoff and the instruction to stop use if pain or vision changes appear are the guardrails the FDA chose.

Community pharmacies are often the first stop for people with red or irritated eyes. Pharmacists will be the ones fielding questions about contact lenses, other drops and when to see a doctor once the product reaches shelves.

Price and launch timing

The open questions are commercial. Alcon has not said when Brytly ships or what it will cost, and the Lumify comparison rests on the company's own figures. Shoppers and pharmacists will see how the pricing and the 12-hour claim stack up once the product is on shelves in the coming months.