Alcon wins FDA approval for BRYTLY eye drops with up to 12‑hour relief
The nonprescription apraclonidine drops are approved for people aged 12 and older, with a U.S. retail launch expected in the coming months.
Adrian Kessler
A new nonprescription option for eye-redness relief is approaching U.S. launch after Alcon Inc. SWXALC NYSEALC won FDA approval for BRYTLY on Friday. Alcon says one drop starts working in one minute and delivers up to 12 hours of redness reduction.
The FDA's Oct. 16 notice identifies the medicine as apraclonidine ophthalmic solution at a concentration of 0.125 per cent. It approved relief of eye redness due to minor irritations in adults and children aged 12 and older, with use capped at twice daily.
Alcon is a large global eye-care group selling surgical and vision-care products internationally, with a consumer portfolio that includes products available without a prescription.
Alcon's shares fell 0.6 per cent to US$66.18 at Friday's New York close, with the NYSEALC quote timestamped 4:00 p.m. EDT. The approval precedes the commercial launch: Alcon expects availability at major U.S. retailers and online in the coming months.
BRYTLY Targets LUMIFY's Eight-Hour Claim
The competing brand is LUMIFY from Bausch + Lomb Corporation NYSEBLCO TSEBLCO. In its July 29, 2025 announcement, Bausch + Lomb said LUMIFY begins working in one minute and lasts up to eight hours.
Alcon's Oct. 16 release says BRYTLY lasts up to 50 per cent longer than LUMIFY. Its footnote bases that comparison on the products' label claims of up to 12 hours and up to eight hours, rather than a reported head-to-head trial.
Duration is the distinction Alcon is presenting to retailers and consumers ahead of launch. Its announcement does not disclose a retail price or sales forecast, leaving the commercial value of that longer duration unquantified. It also anticipates entry into additional markets but gives no country-by-country timetable.
Bausch + Lomb has also expanded its redness-relief range. Its July 29 announcement said it launched a preservative-free version of LUMIFY in the United States in June 2025, adding a formulation for consumers with sensitivities to preservatives. Its shares fell 1.02 per cent to US$16.49 in New York on Friday, with the NYSEBLCO quote timestamped 4:00 p.m. EDT.
The Approval Sets Limits On Use
The FDA called BRYTLY the first nonprescription eye drop containing apraclonidine. The agency said higher concentrations of the ingredient are already available by prescription to lower eye pressure in glaucoma patients or people undergoing certain laser eye procedures.
"Today's approval of Brytly gives consumers a new nonprescription option to manage eye redness conveniently and without needing to see a healthcare provider," FDA drug centre director Mike Davis said in the Oct. 16 notice.
The approved use is redness relief due to minor irritation. Consumers must remove contact lenses before applying the drops and wait at least 10 minutes before reinserting them, according to the FDA.
Read more: Opus Genetics wins FDA approval for presbyopia eye drops
The agency also tells consumers to stop using BRYTLY and ask a doctor if they experience eye pain, vision changes, continued redness or irritation. That advice also applies when the condition worsens or persists for more than three days.
Alcon said its studies showed a low risk of rebound redness and tachyphylaxis, or declining response with repeated use, when BRYTLY was used as directed. The release cites company data on file for those findings without giving participant counts or numerical safety results.
The Oct. 16 announcement sets no specific retail launch date. Alcon's Nov. 11 third-quarter earnings call is the next scheduled investor checkpoint for its commercial plans.
