FDA批准首款非处方阿普拉可乐定滴眼液Brytly 用于缓解轻微刺激引起的眼红
华盛顿——美国食品药品监督管理局（FDA）10月16日批准一款新的非处方滴眼液Brytly（阿普拉可乐定眼用溶液，0.125%），用于缓解轻微刺激引起的眼红。FDA说，这是第一款含阿普拉可乐定的非处方滴眼液，此次批准授予爱尔康公司（Alcon）。
FDA药品评价与研究中心主任迈克·戴维斯（Mike Davis）表示，扩大安全有效的非处方治疗的可及性是FDA的工作重点之一，Brytly的批准为消费者提供了一个无需先看医疗专业人员即可处理眼红的新选择。FDA同时表示，该局正推动鼓励竞争、扩大非处方药供应的条件，此次批准与其公共卫生工作目标一致。
FDA说明，眼红最常见的原因是眼球表面的血管肿胀或扩张，多由干燥、灰尘等轻微刺激引起；较高浓度的阿普拉可乐定此前以处方形式用于降低青光眼患者、或接受某些类型激光眼科手术者的眼压。Brytly仅适用于成人及12岁及以上儿童，每天使用不得超过两次。
FDA公布的使用说明包括：使用前先阅读完整的药品说明标签；滴药前取下隐形眼镜，滴药后至少等10分钟再重新戴上；如需使用其他滴眼液，两种产品之间至少间隔5分钟；如出现眼痛、视力变化、眼红持续或加重，或症状持续超过3天，应停用并咨询医生。（据FDA 10月16日声明）
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)
来源：FDA
发布：GSM·美国（发布链接）
图片来源：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.
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