News

Vertical Pharmaceuticals, LLC, an Osmotica Company, Announces Submission of New Drug Application for RVL-1201

Press Release

Vertical Pharmaceuticals, LLC, an Osmotica Company, Announces Submission of New Drug Application for RVL-1201

September 17, 2019 at 6:50 AM EDT
--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”) (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 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. 

Forward Looking Statements

This press release includes statements that express the Company’s opinions, expectations, beliefs, plans, objectives, assumptions or projections regarding future events or future results and therefore are, or may be deemed to be, “forward-looking statements.” The Company’s actual results may vary significantly from the results anticipated in these forward-looking statements, which can generally be identified by the use of forward-looking terminology, including the terms “believes,” “expects,” “may,” “will,” “should,” “seeks,” “projects,” “approximately,” “intends,” “plans,” “estimates” or “anticipates,” or, in each case, their negatives or other variations or comparable terminology. These forward-looking statements include all matters that are not historical facts. They include statements regarding the Company’s intentions, beliefs or current expectations concerning, among other things, our growth plan, strategies, trends and other events, particularly relating to the development, approval and introduction of new products, FDA and other regulatory applications, approvals and actions.  By their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. We may not achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place significant reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make.  Important factors that could cause actual results and events to differ materially from those indicated in the forward-looking statements include the following: our ability to successfully develop or commercialize new products, or do so on a timely or cost effective basis; failures of or delays in clinical trials or other delays in obtaining regulatory approval or commencing product sales for new products; the impact of competition from both brand and generic companies; any interruption at our manufacturing facility, our warehouses or at facilities operated by third parties that we rely on for our products; our ability to develop and maintain our sales capabilities; the impact of any litigation related to allegations of infringement of intellectual property; any changes to the coverage and reimbursement levels for our products by governmental authorities and other third-party payors as a result of healthcare reform or otherwise; the impact of any changes in the extensive governmental regulation that we face; manufacturing or quality control issues that we may face; and other risks and uncertainties more fully described in the “Risk Factors” section of our Annual Report on Form 10-K for the year ended December 31, 2018 and other filings that the Company makes with the Securities and Exchange Commission. These forward-looking statements speak only as of the time of this release and we do not undertake to publicly update or revise them, whether as a result of new information, future events or otherwise, except as required by law.

Investor and Media Relations for Osmotica Pharmaceuticals plc
Lisa M. Wilson
In-Site Communications, Inc.
T: 212-452-2793
E: lwilson@insitecony.com 

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Source: Osmotica Holdings US LLC