FDA approves Brytly, the first over-the-counter eye drop with apraclonidine, for eye redness

The US Food and Drug Administration (FDA) on 16 October 2026 approved Brytly (apraclonidine ophthalmic solution, 0.125%), a nonprescription eye drop for the relief of eye redness due to minor irritations. The FDA says it is the first over-the-counter eye drop containing apraclonidine. The approval was granted to Alcon.

Key points from the FDA

• Eye redness is most often caused by swollen or dilated blood vessels on the surface of the eye, which can result from minor irritations such as dryness or dust.
• Higher-concentration apraclonidine drops are already available by prescription to lower eye pressure in glaucoma or around certain laser eye surgeries.
• Brytly is approved only for adults and children 12 and older and should not be used more than twice a day.
• Contact lenses should be removed before use and re-inserted no sooner than 10 minutes after; when using other eye drops, wait five minutes between products.
• The FDA says people should stop using it and ask a doctor if they have eye pain, changes in vision, continued redness or irritation, or if the problem lasts more than three days or gets worse.

What to keep in mind

The FDA statement does not describe the clinical trial data behind the approval, so the size of the benefit and side-effect rates are not covered here. Redness relievers treat a symptom, not its cause; persistent red eyes can signal conditions that need medical care. Read the Drug Facts label and talk to your doctor or pharmacist if in doubt.