Vertical Pharmaceuticals, LLC, an Osmotica Company, Announces Acceptance of New Drug Application by FDA for RVL-1201 (Oxymetazoline Hydrochloride Ophthalmic Solution, 0.1%) for Acquired Blepharoptosis (Droopy Eyelid)
--PDUFA date of July 16, 2020--
BRIDGEWATER, N.J., Nov. 20, 2019 (GLOBE NEWSWIRE) -- Vertical Pharmaceuticals, LLC (a subsidiary of Osmotica Pharmaceuticals plc (Nasdaq: OSMT) (“Osmotica” or the “Company”), a fully integrated biopharmaceutical company) today announced that the Company received notification that the New Drug Application (“NDA”) for RVL-1201 (“RVL”) for Acquired Blepharoptosis (droopy eyelid or ptosis) has been filed by the U.S. Food and Drug Administration (“FDA”) with a Prescription Drug User Fee Act (PDUFA) goal date of July 16, 2020.
“We are delighted that our NDA has been accepted for filing. Today, there are no pharmacologic options approved for treatment of droopy eyelid. If approved, RVL would offer physicians and patients a therapeutic option for the treatment of ptosis supported by compelling safety and efficacy data from three well-controlled pivotal studies. With the simplicity of using a once-daily eye drop, RVL has the potential to transform the clinical treatment of acquired blepharoptosis,” said Brian Markison, Osmotica’s Chief Executive Officer.
“We look forward to continuing to engage with key opinion leaders and the medical community to build awareness of this novel therapeutic option for the treatment of droopy eyelid. As we build out our commercial and educational strategy for RVL, we are focused on messaging and pre-launch preparation activities that target both ophthalmologists and optometrists,” concluded Markison.
About Acquired Blepharoptosis
Acquired blepharoptosis is a unilateral or bilateral drooping of the upper eyelid that usually occurs from a partial or complete dysfunction of the muscles that elevate the upper eyelid. It can generally be classified as congenital or acquired, with the most common type being age-related aponeurotic ptosis. The current 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.
About RVL-1201
RVL-1201 is a novel, once-daily ophthalmic formulation of oxymetazoline, a direct-acting α-adrenergic receptor agonist, which when administered to the eye is believed to selectively target Müller’s muscle and elevate the upper eyelid. If approved, RVL-1201 will be the first pharmacologic treatment option for the wide range of patients suffering from droopy eyelid.
About Osmotica Pharmaceuticals plc
Osmotica Pharmaceuticals plc is a fully integrated biopharmaceutical company focused on the development and commercialization of specialty products that target markets with underserved patient populations. Vertical Pharmaceuticals, LLC represents the Company’s diversified branded portfolio, and Trigen Laboratories, LLC represents the non-promoted products including complex generic formulations.
Osmotica has operations in the United States, Argentina, and Hungary.
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Investor and Media Relations for Osmotica Pharmaceuticals plc
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