--RVL-1201 (oxymetazoline hydrochloride ophthalmic solution, 0.1%) is a potential first-in-class pharmacologic treatment option for acquired blepharoptosis (droopy eyelid)--
BRIDGEWATER, N.J., Sept. 17, 2019 (GLOBE NEWSWIRE) -- Vertical Pharmaceuticals, LLC (a subsidiary of Osmotica Pharmaceuticals plc (“Osmotica” or the “Company”) (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 α-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 robust development program with compelling safety and efficacy data from three well-controlled pivotal studies – two efficacy and one extended-duration safety trial.
“We are pleased to submit our NDA to the FDA. As a potential first-in-class pharmacologic treatment, we believe RVL will provide meaningful benefits to patients around the world,” said Brian Markison, Chief Executive Officer of Osmotica Pharmaceuticals. “Our commercial planning and readiness activities are on track for a potential launch in the second half of 2020. We are excited to enter the ophthalmic therapeutic area and look forward to exploring broader global partnership opportunities to help RVL reach its true potential,” 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.
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
Lisa M. Wilson
In-Site Communications, Inc.