Vertical Pharmaceuticals, LLC (a subsidiary of Osmotica Pharmaceuticals plc, a fully integrated biopharmaceutical company), has announced the submission of an NDA to the FDA for approval of RVL-1201 for the treatment of acquired blepharoptosis (ptosis or droopy eyelid). RVL is a novel, once-daily ophthalmic formulation of the direct-acting alpha-adrenergic receptor agonist oxymetazoline, which when administered to the eye is believed to selectively target Müller’s muscle and elevate the upper eyelid.
The current standard of care for ptosis 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 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.
Phase III clinical trial data for RVL-1201 will be presented at the following meetings:
- Ophthalmology Innovation Summit, San Francisco, California - Innovation Showcase presentation, Oct 10, 11:51am
- American Society of Ophthalmic Plastic and Reconstructive Surgery (ASOPRS) Fall Scientific Symposium, San Francisco, California - Digital presentation, Oct 10-11, 2019
- American Academy of Optometry Academy Conference 2019, Orlando, Florida - Poster presentation, Oct 24, 4:30-6:30 pm and Vision Theater presentation, Oct 25, 11:00-11:30am
- Academy of Managed Care Pharmacy (AMCP) Nexus 2019, National Harbor, Maryland - Poster presentation, Oct 31, 12:30-2:00 pm
- 16th annual American Academy of Aesthetic Medicine (AAAM) Congress 2019, Las Vegas, Nevada - Podium presentation, Nov 9, 5:40-5:55pm
“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.
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.
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