The FDA has approved Brytly (apraclonidine ophthalmic solution 0.125%) as an over-the-counter treatment for eye redness caused by minor irritations such as dryness or dust exposure. The agency described the product as the first nonprescription formulation of apraclonidine, an alpha-adrenergic agonist previously available only in prescription strength for preventing postsurgical intraocular pressure spikes.
According to the FDA announcement, the approval is aimed at expanding consumer access to safe nonprescription options. Mike Davis, MD, PhD, director of the FDA's Center for Drug Evaluation and Research, said the new product lets people manage eye redness conveniently without visiting a healthcare provider. The approval is limited to patients aged 12 and older, and directs users to apply the drops no more than twice per day.
The label includes specific precautions: contact lens wearers should remove lenses before application and wait at least 10 minutes before reinserting them, and patients using multiple eye drops should wait at least 5 minutes between products to prevent washout. The FDA also says the product should not be used if it becomes cloudy, and that users should stop and contact a doctor if eye pain, vision changes, or redness persists beyond three days or worsens. The license was granted to Alcon.