Date: 16-Oct-2026
On 16 October 2026, the U.S. Food and Drug Administration (USFDA) approved BRYTLY (apraclonidine ophthalmic solution 0.125%), developed by Alcon Laboratories, Inc., as a nonprescription treatment for eye redness caused by minor irritations.
BRYTLY is approved for adults and children aged 12 years and older. It provides a new over-the-counter (OTC) option for managing eye redness, expanding access to nonprescription eye-care treatments.
The product contains apraclonidine, an alpha-2 adrenergic agonist previously available in higher-concentration prescription eye-drop formulations for reducing intraocular pressure. BRYTLY represents the first nonprescription eye-drop product containing apraclonidine approved by the USFDA.
According to Alcon, BRYTLY begins reducing eye redness within one minute, with effects lasting up to 12 hours when used as directed. The product is expected to become available through major U.S. retailers and online channels in the coming months.
Key approval details:
- Product name: BRYTLY
- Active ingredient: Apraclonidine
- Strength: 0.125%
- Dosage form: Ophthalmic solution
- Applicant: Alcon Laboratories, Inc.
- Regulatory authority: USFDA
- Approval date: 16 October 2026
- Indication: Relief of eye redness due to minor irritations
- Prescription status: Nonprescription (OTC)
- Eligible population: Adults and children aged 12 years and older
This approval expands the OTC eye-care market by introducing a new apraclonidine-based option for eye redness relief.
Source: https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/220341Orig1s000ltr.pdf https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=220341