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charles slonim, mark silverberg, Barry Butler, William Stringer, Lisa Butler, Ronil Patel, Jeremy Brace; RVL-1201 Ophthalmic Solution improves the superior field of vision in subjects with upper eyelid ptosis.. Invest. Ophthalmol. Vis. Sci. 2017;58(8):3835.
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© ARVO (1962-2015); The Authors (2016-present)
Blepharoptosis refers to inferodisplacement of the upper eyelid. It is one of the most common eyelid disorders occurring in about 12% of adults over age 50. It may cause significant superior visual field impairment as the upper eyelid margin obstructs the superior visual field. Treatment is surgical and targets 1 of 2 upper eyelid retractor muscles: the levator muscle and Müller’s muscle. Müller’s muscle is innervated by adrenergic fibers from the cervical sympathetic chain. The active ingredient of RVL-1201 (oxymetazoline 0.1%) is an α1 and partial α2 adrenergic agonist capable of contracting Müller’s muscle through direct transconjunctival contact of this sympathomimetic agent. The result is upper eyelid elevation.
140 subjects in a Phase 3, randomized, multicenter, double-masked, placebo-controlled study were randomized in a 2:1 ratio into 1 of 2 treatment arms and treated with RVL-1201 or placebo (vehicle) once daily for 6 weeks. Blepharoptosis was defined as lid marginal (light) reflex distance (MRD) ≤ 2.5mm and a superior visual field loss of ≥8 points out of the top 2 rows of a possible 17 points using a Leicester Peripheral Field Test (LPFT) program on the Humphrey Visual Field analyzer. Four rows (35 points) exist at or above 10° from fixation in the superior visual field. Dosing once every morning, Group 1 (N = 95) took one drop of RVL-1201 per eye and Group 2 (N = 45) took one drop of vehicle per eye. The study eye was used in the analysis of efficacy.
The number of LPFT points seen was significantly increased in RVL-1201 group vs the vehicle group compared to baseline at both primary efficacy time points (values shown are mean difference between groups, P-value, 95% confidence limits): Day 1 Hour 6 (3.68, P < 0.0001, 2.00, 5.36) and Day 14 Hour 2 (4.41, P < 0.0001, 2.52, 6.31). Significant increases in MRD were also found between the RVL-1201 and vehicle groups compared to baseline at both primary efficacy time points. RVL-1201 was well tolerated; the adverse event profile was similar between the RVL-1201 and vehicle groups.
These results support the hypothesis that once daily RVL-1201 Ophthalmic Solution significantly improves the superior visual field by increasing the number of points seen when compared to vehicle and elevates a ptotic upper eyelid. This product could serve as an alternative nonsurgical treatment for upper eyelid ptosis.
This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.
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