Vertical Pharmaceuticals, LLC, Announces Presentation of Phase III RVL-1201 Clinical Trial Data in Patients with Acquired Blepharoptosis

Vertical Pharmaceuticals, LLC, Announces Presentation of Phase III RVL-1201 Clinical Trial Data in Patients with Acquired Blepharoptosis (ptosis or droopy eyelid)

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., September 18, 2019 – Vertical Pharmaceuticals, LLC, a subsidiary of Osmotica Pharmaceuticals plc (“Osmotica” or the “Company”) (Nasdaq: 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) submission for RVL-1201 complete, 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,” says Brian Markison, Osmotica Chairman & CEO.

RVL-1201 is a novel first-in-class pharmacologic agent in development for the treatment of acquired blepharoptosis (ptosis or droopy eyelid). In the US, there are currently no approved pharmacologic treatments for acquired blepharoptosis. 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. If approved, RVL-1201 (a direct-acting, α-adrenergic receptor agonist) will be a simple noninvasive therapy that is administered topically to the eye and has the potential to benefit ptosis patients.

If the NDA for RVL-1201 is approved, the US launch is expected in the third quarter of 2020.

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, Oct 10, time TBD
  • 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
  • 16th 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 currently approved option is surgery.” says 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”, says 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 drooping of the upper eyelid that usually occurs from a partial or complete dysfunction of the muscles that elevate the upper eyelid. If FDA approved, RVL-1201 would be the first non-surgical treatment option for patients with acquired blepharoptosis.

About Vertical Pharmaceuticals, LLC

Vertical Pharmaceuticals, LLC, is a division of Osmotica Pharmaceuticals plc, a fully integrated biopharmaceutical company with corporate offices in Bridgewater, NJ, focused on developing, manufacturing and commercializing specialty products. Our diversified product portfolio forms the foundation of our unwavering commitment to improving patients’ lives, while our late-stage pipeline is highlighted by two NDA candidates that recently completed Phase III clinical trials: arbaclofen extended‑release tablets for spasticity in multiple sclerosis patients, and RVL‑1201 (oxymetazoline hydrochloride ophthalmic solution, 0.1%) for the treatment of acquired blepharoptosis (ptosis or droopy eyelid).