Phase 3 Trials Find RVL-1201 Safe, Efficacious for Blepharoptosis

Congenital ptosis. A drooping eyelid is called ptosis or blepharoptosis. If the case is severe, the eyelid might cover the pupil and interfere with vision.
Two randomized, phase 3 trials were conducted to assess the safety and efficacy of oxymetazoline HCl, 0.1% ophthalmic solution in the treatment of acquired blepharoptosis.

The following article is a part of conference coverage from the American Academy of Ophthalmology 2020, being held virtually from November 13 to 15, 2020. The team at Ophthalmology Advisor will be reporting on the latest news and research conducted by leading experts in ophthalmology. Check back for more from the AAO 2020.

Treatment of acquired blepharoptosis with RVL-1201 (oxymetazoline HCl ophthalmic solution, 0.1%) was found to be both safe and efficacious regardless of patient age or race, according to data presented at the American Academy of Ophthalmology 2020 Annual Meeting, held virtually November 13 to 15, 2020.

Investigators conducted patient subgroup analyses using data from 2 randomized, phase 3 clinical trials ( identifiers NCT02436759 and NCT03565887). In total, 304 patients received either RVL-1201 or vehicle once daily for 42 days. Study outcomes included efficacy — measured as change from baseline in visual field testing and marginal reflex distance-1 (MRD-1) over 14 days — and safety analyses.

Results demonstrated significant improvement in both visual field test performance and MRD-1 in participants aged 18 to 75 years (P <.05). In participants aged 75 years and older, visual field test results also improved with RVL-1201 therapy (P <.05). 

White participants (n=177) experienced significantly improved performance in visual field test and MRD-1 with RVL-1201 (P <.001), and nonwhite participants experienced numerically but not statistically improved performance (n=26; P <.05). 

Adverse event rates ranged from 24.3% to 38.5% and were comparable across subgroups. 

“RVL-1201 used once daily for 42 days had a consistent efficacy and safety profile across subgroups based on age [and] race,” the researchers concluded.

Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures. 


Wirta DL, Smyth-Medina RJ, Slonim CB. Efficacy and safety of RVL-1201 (oxymetazoline 0.1%) for acquired blepharoptosis: patient subgroup analysis from two phase 3 studies. Presented at: American Academy of Ophthalmology 2020 Annual Meeting; November 13-15, 2020. Abstract PO298.

Visit Ophthalmology Advisor’s conference section for complete coverage of AAO 2020.