Mizuho Securities USA LLC has reiterated its ‘Buy’ rating and price target of $70 on shares of Aerie Pharmaceuticals, Inc.’s (NASDAQ: AERI) stock following the FDA’s Dermatologic and Ophthalmic Drug Advisory Committee vote in favor of Rhopressa. The committee’s decision regarded two key points: efficacy for reducing intraocular pressures (IOP) and efficacy outweighing safety risks. First, the committee voted 10-0 when asked if the clinical trials support Rhopressa’s efficacy for reducing elevated IOP for patients with open-angle glaucoma or ocular hypertension. The second question posed to the committee asked if the identified safety risks were outweighed by the efficacy demonstrated during clinical trials of Rhopressa. This question resulted in a vote of 9-1. The analyst expects Rhopressa to be approved on or before its PDUFA goal date of February 28, 2018.
For more information, visit: www.AeriePharma.com
About Aerie Pharmaceuticals, Inc.
Aerie is a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of patients with glaucoma and other diseases of the eye. Aerie’s two current product candidates are once-daily intraocular pressure lowering therapies with novel mechanisms of action to treat patients with glaucoma or ocular hypertension. The NDA (new drug application) for Rhopressa™ (netarsudil ophthalmic solution) 0.02% was submitted to the U.S. Food and Drug Administration (FDA) in February 2017, and, in May 2017, the FDA set the PDUFA (Prescription Drug User Fee Act) goal date for the completion of the FDA’s review™ (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%, which is a fixed dose combination of Rhopressa™ and widely prescribed PGA latanoprost, achieved its primary efficacy endpoint in two Phase 3 registration trials, named Mercury 1 and Mercury 2, and also achieved successful 12-month safety and efficacy results in Mercury 1. The Roclatan™ NDA submission is expected to take place in the first half of 2018. Aerie is also focused on the development of additional product candidates and technologies in ophthalmology.
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