FDA Approves Brytly, the First Nonprescription Apraclonidine Eye Drop, for Eye Redness
The Oct. 16 approval covers apraclonidine 0.125% for adults and children 12 and older, at most twice a day. The FDA did not describe the trial data, and the Drug Facts label was not yet posted, so the stop-use rules are what clinicians can act on now.
On Oct. 16, the Food and Drug Administration approved Brytly (apraclonidine ophthalmic solution 0.125%) as a nonprescription eye drop for relief of eye redness due to minor irritations. The agency said it is the first nonprescription eye drop with apraclonidine. The FDA announcement does not name the sponsor; Drug Topics reported that the approval was granted to Alcon.
Apraclonidine is an alpha-2 adrenergic agonist. Until now it has been sold only by prescription, at higher strengths: MedlinePlus lists a 0.5% solution for short-term glaucoma treatment and a 1% solution to blunt pressure spikes around certain laser eye procedures. Brytly brings a lower strength of the same molecule to the pharmacy shelf, where patients can buy it without seeing anyone.
What the label says so far
The FDA said Brytly is approved only for adults and children 12 and older and should not be used more than twice a day. Users should remove contact lenses before use and wait at least 10 minutes before reinserting them, and wait five minutes between Brytly and any other eye drop.
The agency lists reasons to stop and ask a doctor: eye pain, changes in vision, continued redness or irritation, or a condition that persists for more than three days or worsens. "Today's approval of Brytly gives consumers a new nonprescription option to manage eye redness conveniently and without needing to see a healthcare provider," Mike Davis, M.D., Ph.D., director of the FDA's Center for Drug Evaluation and Research, said in the announcement.
Eye redness that has not cleared in three days is a reason to examine the eye, not to keep treating its surface.
What we do not know yet
The FDA announcement does not describe the trials behind the approval, and the full Drug Facts label had not been posted to the National Library of Medicine's DailyMed database as of Oct. 16. That leaves open the questions a clinician would ask first: the size of the effect, how long it lasts, whether redness rebounds after stopping and what warnings the label carries.
The prescription strengths offer some context but not answers. MedlinePlus patient information for those products lists possible side effects including red, itchy or teary eyes, raised eyelids, dry mouth, dizziness and an irregular or slow heartbeat. Whether any of these matter at one-eighth the 1% concentration will depend on the label. Brytly also is not the first alpha-2 agonist for redness: the FDA approved low-dose brimonidine (Lumify) for over-the-counter use in late 2017.
What it means in clinic
Pharmacies are often the first stop for a red eye, and an over-the-counter drop may change who calls and when. It can also delay presentation. Redness with pain, light sensitivity, discharge or reduced vision still needs a same-day exam, and a patient who has whitened the eye with drops for several days may arrive with a less obvious picture.
Add one question to red-eye triage, by phone or at intake: which drops have you used, and for how long? Make sure staff who take calls know the FDA's stop-use criteria and the contact lens rule. Until the label and any postmarketing data are available, treat Brytly as a convenience for minor irritation, not as a treatment for anything a patient would otherwise bring to you. Our coverage of the FDA advisory review of low-dose atropine covers another eye drop under FDA review this month.
Reported, fact-checked and edited by The Script Pad's editorial staff.
This article is for professional education and does not replace clinical judgment. Treatment decisions should be based on the individual patient and current guidelines.
