New Drug application filed for Acquired Blepharoptosis after promising results in clinical trial
Acquired blepharoptosis is a unilateral or bilateral drooping of the upper eyelid in which usually surgery is the answer although the results in most cases are not encouraging. A pharmaceutical company named, Vertical Pharmaceuticals, LLC (a subsidiary of Osmotica Pharmaceuticals plc) has recently announced that it has filed New Drug Application (NDA) for its oxymetazoline hydrochloride ophthalmic solution, 0.1% formula-- RVL-1201 for the treatment of acquired blepharoptosis or droopy eyelids, following its promising results in its Phase III clinical trial.
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.
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.
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 the change from baseline in the 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).