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RVL Pharmaceuticals Upneeq® Wins 2021 MedTech Breakthrough Award

Press Release

RVL Pharmaceuticals Upneeq® Wins 2021 MedTech Breakthrough Award

May 10, 2021 at 8:30 AM EDT

Annual Awards Program Recognizes Outstanding Health & Medical Technology Products and Companies

BRIDGEWATER, N.J., May 10, 2021 (GLOBE NEWSWIRE) -- RVL Pharmaceuticals, Inc., a subsidiary of Osmotica Pharmaceuticals plc (Nasdaq: OSMT) (“Osmotica”), a fully integrated biopharmaceutical company, today announced that its Upneeq® (oxymetazoline hydrochloride ophthalmic solution), 0.1% has been selected as the winner of the “Best New Technology Solution for Drug Delivery” award in the fifth annual MedTech Breakthrough Awards program conducted by MedTech Breakthrough, an independent market intelligence organization that recognizes the top companies, technologies and products in the global health and medical technology market.

Upneeq® provides patients and eye care providers with a safe and convenient non-surgical option to treat adults with acquired blepharoptosis (ptosis). The FDA-approved eye drop is the first and only therapeutic approved for the condition which previously required a surgical procedure. Upneeq® is a safe and effective, first-in-class treatment for acquired ptosis and it demonstrated statistically significant improvements compared to placebo in both superior visual field and eyelid lift, as measured in two pivotal double-masked efficacy studies. The medication is composed of oxymetazoline hydrochloride ophthalmic solution, 0.1%.

“This eyedrop represents a true therapeutic innovation, empowering eye care specialists with a safe and convenient non-surgical option to treat their patients who have ptosis,” said James Johnson, managing director, MedTech Breakthrough. “We extend our sincere congratulations to RVL Pharmaceuticals for winning our ‘Best New Technology Solution for Drug Delivery’ award and, more importantly, improving the lives of millions of patients through the use of their first in class Upneeq® solution.”

The mission of the MedTech Breakthrough Awards is to honor excellence and recognize the innovation, hard work and success in a range of health and medical technology categories, including Robotics, Clinical Administration, Telehealth, Patient Engagement, Electronic Health Records (EHR), mHealth, Medical Devices, Medical Data and many more. This year’s program attracted more than 3,850 nominations from over 17 different countries throughout the world.

“Low-lying lids have both visual consequences, as the abnormal drooping of the upper eyelid can lead to vision impairment, and cause cosmetic concerns for the sufferer,” said Brian Markison, CEO of Osmotica Pharmaceuticals. “Due to the lack of an approved non-surgical treatment, ptosis has been often underdiagnosed or overlooked. We believe Upneeq® has the potential to address a significant unmet need in ptosis therapy and we are grateful to receive this 2021 MedTech Breakthrough Award in recognition of our hard work and innovation in this space.”

The product has garnered interest from eye care physicians to those in the medical aesthetics field. Upneeq® is available to patients through RVL Pharmaceuticals’ subsidiary, RVL Pharmacy, LLC, ensuring its widespread availability.

IMPORTANT SAFETY INFORMATION
INDICATION
UPNEEQ® (oxymetazoline hydrochloride ophthalmic solution), 0.1% is indicated for the treatment of acquired blepharoptosis in adults.

WARNINGS AND PRECAUTIONS

  • Ptosis may be associated with neurologic or orbital diseases such as stroke and/or cerebral aneurysm, Horner syndrome, myasthenia gravis, external ophthalmoplegia, orbital infection and orbital masses. Consideration should be given to these conditions in the presence of ptosis with decreased levator muscle function and/or other neurologic signs.
  • Alpha-adrenergic agonists as a class may impact blood pressure. Advise UPNEEQ patients with cardiovascular disease, orthostatic hypotension, and/or uncontrolled hypertension or hypotension to seek medical care if their condition worsens.
  • Use UPNEEQ with caution in patients with cerebral or coronary insufficiency or Sjögren’s syndrome. Advise patients to seek medical care if signs and symptoms of potentiation of vascular insufficiency develop.
  • UPNEEQ may increase the risk of angle closure glaucoma in patients with untreated narrow-angle glaucoma. Advise patients to seek immediate medical care if signs and symptoms of acute narrow-angle glaucoma develop.
  • Patients should not touch the tip of the single patient-use container to their eye or to any surface, in order to avoid eye injury or contamination of the solution.

ADVERSE REACTIONS

Adverse reactions that occurred in 1-5% of subjects treated with UPNEEQ were punctate keratitis, conjunctival hyperemia, dry eye, blurred vision, instillation site pain, eye irritation and headache.

DRUG INTERACTIONS

  • Alpha-adrenergic agonists, as a class, may impact blood pressure. Caution in using drugs such as beta-blockers, anti-hypertensives, and/or cardiac glycosides is advised. Caution should also be exercised in patients receiving alpha adrenergic receptor antagonists such as in the treatment of cardiovascular disease, or benign prostatic hypertrophy.
  • Caution is advised in patients taking monoamine oxidase inhibitors which can affect the metabolism and uptake of circulating amines.

About Osmotica Pharmaceuticals plc
Osmotica Pharmaceuticals plc (Nasdaq: OSMT) is a fully integrated biopharmaceutical company focused on the development and commercialization of specialty products that target markets with underserved patient populations. The company has a diverse portfolio consisting of promoted and non-promoted products, several of which incorporate Osmotica’s proprietary Osmodex® drug delivery system. RVL Pharmaceuticals, Inc. is the Company’s ophthalmic subsidiary supporting Upneeq®. Vertical Pharmaceuticals, LLC represents the Company’s diversified branded portfolio and Trigen Laboratories, LLC represents the Company’s non-promoted products, including complex generic formulations. Osmotica has operations in the United States, Argentina, and Hungary.

About MedTech Breakthrough
Part of Tech Breakthrough, a leading market intelligence and recognition platform for global technology innovation and leadership, the MedTech Breakthrough Awards program is an independent program devoted to honoring excellence in medical and health related technology companies, products, services and people. The MedTech Breakthrough Awards provide a platform for public recognition around the achievements of breakthrough health and medical companies and products in categories that include Patient Engagement, mHealth, Health & Fitness, Clinical Administration, Healthcare IoT, Medical Data, Healthcare Cybersecurity and more. For more information visit MedTechBreakthrough.com

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