FDA Approves Brytly, the First Nonprescription Apraclonidine Eye Drop, for Relief of Eye Redness
WASHINGTON — The U.S. Food and Drug Administration (FDA) on October 16 approved a new nonprescription eye drop, Brytly (apraclonidine ophthalmic solution, 0.125%), for the relief of eye redness due to minor irritations. The FDA said it is the first nonprescription eye drop containing apraclonidine, and the approval was granted to Alcon.
Mike Davis, director of the FDA's Center for Drug Evaluation and Research, said expanding access to safe and effective nonprescription treatments is a priority for the agency, and that the approval gives consumers a new option to manage eye redness without needing to see a healthcare provider. The FDA said the decision aligns with its public health goals of fostering competition and expanding the availability of nonprescription drugs.
The agency said eye redness is most frequently caused by swollen or dilated blood vessels on the surface of the eye, resulting from minor irritations such as dryness or dust, and noted that higher concentrations of apraclonidine are available by prescription to reduce eye pressure in glaucoma patients or those undergoing certain laser eye surgeries. Brytly is approved only for adults and children 12 years of age and older, and should not be used more than two times per day.
Before using Brytly, consumers should read the full Drug Facts label, the FDA said. Contact lenses should be removed before use and not re-inserted for at least 10 minutes after applying the drops; if additional eye drops are used, consumers should wait five minutes between products. Consumers should stop using Brytly and ask a doctor if they experience eye pain, changes in vision, continued redness or irritation, or if the condition persists for more than three days or worsens. (According to the FDA statement of October 16)
Source: FDA
Published by GSM · USA (original Chinese edition)
Photo: 美国食品药品监督管理局（FDA）白橡树园区总部入口（资料图），FDA官方照片，公共领域，via Wikimedia Commons。Entrance of FDA headquarters at the White Oak campus (file photo), FDA official photo, public domain, via Wikimedia Commons.
