Results from Three Pivotal Phase III Efficacy and Safety Trials (Studies RVL-1201-201, 202 and 203) to Be Presented at Multiple Global Congresses

BRIDGEWATER, N.J., Sept. 18, 2019 (GLOBE NEWSWIRE) — Vertical Pharmaceuticals, LLC (a subsidiary of Osmotica Pharmaceuticals plc (“Osmotica” or the “Company”) (OSMT), a fully integrated biopharmaceutical company) today announced that Phase III clinical trial results for RVL-1201 (oxymetazoline hydrochloride ophthalmic solution, 0.1%) will be presented at multiple global congresses in October and November.

“With the New Drug Application (NDA) now submitted for RVL-1201, we are excited to have the opportunity to present these data and build upon the scientific and medical awareness of RVL-1201 and acquired blepharoptosis,” said Brian Markison, Osmotica’s Chief Executive Officer.

Phase III clinical trial data for RVL-1201 will be presented at the following meetings:

• Ophthalmology Innovation Summit (OIS@AAO 2019), October 10, 2019, San Francisco, California
  • Innovation Showcase podium presentation, October 10, 2019
• American Society of Ophthalmic Plastic and Reconstructive Surgery (ASOPRS) Fall Scientific Symposium, Oct 10-11, 2019, San Francisco, California
  • Digital presentation, Oct 10-11, 2019
• American Academy of Optometry (AAOptom) Academy Conference 2019, Oct 23-27, 2019, Orlando, Florida
  • Poster presentation, Oct 24, 4:30-6:30 pm
  • Vision Theater (podium) presentation, Oct 25, 11:00-11:30 am
• Academy of Managed Care Pharmacy (AMCP) Nexus 2019, Oct 29-Nov 1, 2019, National Harbor, Maryland
  • Poster presentation, Oct 31, 12:30-2:00 pm
• 16^th annual American Academy of Aesthetic Medicine (AAAM) Congress, Nov 8-11, 2019, Las Vegas, Nevada
  • Podium presentation, Nov 9, 5:40-5:55 pm

“We are excited to present results from the Phase III RVL-1201 studies to all of our eye care colleagues this fall. This product has the potential to revolutionize the clinical treatment of acquired blepharoptosis. The study results, combined with the simplicity of using a once-daily eye drop, would make RVL-1201 a very welcome addition to our treatment armamentarium if approved by the FDA, where the only current option is surgery,” said Michael Korenfeld, MD, founder of Comprehensive Eye Care in Washington, Missouri.

“Since optometrists are the first line of care for ptosis patients and there are no pharmacologic options approved for treatment, if approved, RVL-1201 would be an exciting therapeutic option. As a safe, effective, and simple pharmaceutical treatment for acquired blepharoptosis, RVL-1201 may provide optometrists with an opportunity to build their practices and also retain their patients who currently must be referred for surgical treatment,” said Shane Foster OD, owner of Athens Eye Care in Athens, Ohio.

Phase III Trials Assessing Efficacy and Safety of RVL-1201

Two clinical trials in the U.S., Study RVL-1201-201 and Study RVL-1201-202 were conducted to demonstrate the efficacy of RVL-1201. Both were multicenter, double-masked, placebo-controlled clinical trials of 6 weeks’ duration. The studies compared once-daily RVL-1201 with placebo (vehicle) in subjects with acquired blepharoptosis. The primary efficacy endpoint was the mean change from baseline in the number of points seen on the Leicester Peripheral Field Test, which measures the superior (upper) field of vision. Secondary efficacy endpoints included change from baseline in marginal reflex distance (MRD1), which measures the distance from the center pupillary light reflex to the central margin of the upper eyelid. Safety assessments included adverse event monitoring and reporting, vital sign monitoring, and ophthalmic examination.

A third clinical trial conducted in the U.S., Study RVL-1201-203, assessed the long-term safety of RVL-1201. The study was a multicenter, double‑masked, placebo‑controlled trial conducted over 84 days. The primary endpoint was safety as assessed by adverse event monitoring and reporting throughout the study. Additional assessments included tolerability and ophthalmic examination (pupil diameter, Snellen visual acuity, corneal fluorescein staining, and intraocular pressure).

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 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. 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-1201 will be the first pharmacologic treatment option for the wide range of patients suffering from droopy eyelids.

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.