Vertical Pharmaceuticals, LLC, an Osmotica Company, Announces Submission of New Drug Application for RVL-1201
Osmotica Pharmaceuticals plc - Ordinary Shares (OSMT)
Last osmotica pharmaceuticals plc - ordinary shares earnings: 3/18 04:05 pm
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Source: GlobeNewswire
BRIDGEWATER, N.J., Sept. 17, 2019 (GLOBE NEWSWIRE) -- Vertical Pharmaceuticals, LLC (a subsidiary of Osmotica Pharmaceuticals plc (“Osmotica” or the “Company”) (Nasdaq: OSMT), a fully integrated biopharmaceutical company), today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of RVL-1201 (RVL) for the treatment of acquired blepharoptosis (droopy eyelid). RVL is a novel, once-daily ophthalmic formulation of oxymetazoline, a direct-acting a-adrenergic receptor agonist, which when administered to the eye is believed to selectively target Müller’s muscle and elevate the upper eyelid. The standard of care is surgery, which is often reserved only for severe cases and may carry an increased risk of adverse events such as infection, bleeding, and asymmetry. If approved, RVL will be the first pharmacologic treatment option for the wide range of patients suffering from droopy eyelids. The NDA submission is supported by a
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