Clinical responsiveness to RVL-1201, a novel oxymetazoline 0.1% ophthalmic solution for the treatment of acquired blepharoptosis: results from two phase 3 clinical studies

Abstract

Purpose : RVL-1201 (oxymetazoline 0.1%) is a novel pharmacologic agent administered as a once-daily eye drop for the treatment of acquired blepharoptosis in adults. Phase 3 clinical data support the efficacy of RVL-1201, demonstrating significant mean improvement of superior visual field deficits and elevation of the upper eyelid. Clinically, it is important to define the overall responsiveness of the study population to treatment to fully ascertain the robustness of the treatment effect. The purpose of this analysis was to evaluate the proportion of subjects demonstrating a positive response to once-daily RVL-1201 administration.

Methods : In two randomized, double-masked, placebo-controlled phase 3 clinical studies, N=304 subjects received RVL-1201 or vehicle once daily in both eyes for 42 days. This analysis evaluated the proportion of subjects demonstrating a positive clinical response to RVL-1201 (relative to their pre-dose baseline measurement on treatment day 1), with respect to the primary study efficacy endpoint: number of points seen in the top 4 rows of the Leicester Peripheral Field Test (LPFT). For LPFT assessment, ‘any improvement,’ ‘≥50% improvement,’ and ‘≥90% improvement’ were defined as a >0% increase, ≥50% increase, and ≥90% increase, respectively, in the number of points seen versus baseline.

Results : Two hours following RVL-1201 instillation on treatment day 14 (n=203 RVL-1201; n=101 vehicle), 87.8% of subjects demonstrated some degree of improvement (>0%) on the LPFT, 40.8% of subjects demonstrated ≥50% improvement, and 16.8% of subjects demonstrated ≥90% improvement on this measure of superior visual field function. In contrast, 60.8%, 18.6%, and 5.2% of subjects in the vehicle group demonstrated any improvement, ≥50% improvement, and ≥90% improvement, respectively.

Conclusions : These data support previously reported efficacy findings from phase 3 clinical studies. A large proportion of subjects demonstrated a positive response to once-daily RVL-1201 administration (superior visual field improvement). These results substantiate RVL-1201 as a potentially promising non-surgical treatment option for patients with acquired blepharoptosis.

This is a 2021 ARVO Annual Meeting abstract.