FDA Approves Brytly for OTC Eye Redness Relief

The FDA approved Brytly (apraclonidine ophthalmic solution 0.125%) Friday as a nonprescription option for the treatment of eye redness, according to the FDA.¹ Only differing in dosing, Brytly widens the reach of previously approved apraclonidine formulations, notably the prescription version, Iopidine, approved in June 2022.^2,3

“Expanding access to safe and effective nonprescription treatments is a priority for FDA," said Mike Davis, MD, PhD, director of the FDA Center for Drug Evaluation and Research (CDER), according to the release.¹ “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.”

Granted to Alcon, this nonprescription approval introduces apraclonidine to the over-the-counter (OTC) market. Prior trademark filings show Alcon Inc. secured the BRYTLY mark under Class 005 for ophthalmic pharmaceutical preparations on an intent-to-use basis. The approval aligns with public health goals to expand consumer access to self-care therapies for minor eye irritations like dryness or dust.^1,4

READ MORE: GLP-1s Linked With Increased Risk of Optic Nerve Disorders

From Prescription Surgery Suites to OTC Access

Before this approval, apraclonidine was available exclusively in higher-concentration prescription formulations. Harrow Health commercialized prescription Iopidine (1% ophthalmic solution) in June 2022 to prevent post-surgical intraocular pressure spikes during laser-eye procedures.^1-3

As an alpha-2 adrenergic agonist, apraclonidine lowers intraocular pressure by reducing fluid production inside the eye. Pharmacist reviews note that, despite prescription versions managing elevated pressure, like Iopidine 1% or generic 0.5% drops, they require monitoring for side effects like eyelid elevation, irregular heartbeat, ocular inflammation, dizziness, and drug interactions.³

In contrast, Brytly features a 0.125% concentration formulated for temporary redness relief in adults and children 12 years and older, limited to 2 applications daily. Contact lens wearers must remove lenses prior to application and wait at least 10 minutes before reinserting them. When using multiple eye drops, patients should separate applications by at least 5 minutes to prevent drug washout.¹

Clinical Practice Guidance and the Vital Role of Community Pharmacists

Community pharmacies are frequently the first stop for patients with red eyes, itching, or minor irritations.^5,6

“Community pharmacies are often the first place many patients with eye problems will go to for help, especially in low- and/or middle-income countries, such as Ghana,” according to a study in the Community Eye Health Journal.⁵ “So it is useful to empower the people who work there with basic knowledge of common eye disorders.”

Pharmacists serve as essential clinical gateways within the eye care team, assessing whether symptoms stem from mild allergic reaction, infection, or a more serious issue. In providing self-care advice, pharmacists play an indispensable role in educating consumers on proper eye drop application, adherence, and safety limits. Educational guidelines emphasize recognizing red flag symptoms that require immediate medical referral.^5,6

Pharmacists must counsel patients using Brytly to stop use and consult a doctor if they experience eye pain, vision changes, continued redness, or if symptoms persist beyond 3 days. Additionally, practice standards warn pharmacists never to recommend OTC topical steroid drops without ophthalmologist oversight, as steroids can worsen corneal ulcers or induce secondary glaucoma.^1,5

Through patient counseling and structured referral pathways with eye care specialists, community pharmacists ensure that nonprescription options like Brytly enhance patient convenience safely.⁶

“In the community setting, the pharmacy is often seen as simply the location at which patients collect their medication,” concluded authors of a separate study in the Community Eye Health Journal.⁶ The community pharmacy is, however, an essential point of contact for primary health care, including primary eye care. Patients come to seek advice about a wide range of conditions and about OTC or prescribed medication.”

READ MORE: Eye Health Resource Center

REFERENCES

1. FDA approves new nonprescription eye drop for relief of eye redness. FDA. News Release. October 16, 2026. Accessed October 16, 2026. https://www.fda.gov/drugs/drug-alerts-and-statements/fda-approves-new-nonprescription-eye-drop-relief-eye-redness?utm_medium=email&utm_source=govdelivery

2. Harrow Health announces launch of IOPIDINE® 1% and MAXITROL® in the United States. Harrow Health. News Release. June 24, 2022. Accessed October 16, 2026. https://www.harrow.com/news-releases/news-release-details/harrow-health-announces-launch-iopidiner-1-and-maxitrolr-united

3. Iopidine (apraclonidine) prices. GoodRx. September 9, 2024. Accessed October 16, 2026. https://www.goodrx.com/iopidine/what-is

4. BRYTLY. Trademarkia. May 6, 2026. Accessed October 16, 2026. https://www.trademarkia.com/brytly-98411714

5. Wiafe B. Providing eye care education for pharmacists. Community Eye Health. 2023;36(118):13.

6. Patel P. Valuing pharmacists as members of the eye team. Community Eye Health. 2023;36(118):12-13.