This article is part of Ophthalmology Advisor’s conference coverage from the 2021 meeting of American Society of Cataract and Refractive Surgery (ASCRS), held in Las Vegas from July 23 to 27, 2021. The team at Ophthalmology Advisor will be reporting on a variety of research presented by the cataract and refractive surgery experts at ASCRS. Check back for more from the ASCRS 2021 Meeting.
OTX-101 therapy is a safe and well tolerated way to increase tear production in patients with keratoconjunctivitis sicca, according to research results presented at the American Society of Cataract and Refractive Surgery (ASCRS) 2021 meeting in Las Vegas.
In a pooled analysis, researchers evaluated the outcomes of phase 2b/3 and phase 3 randomized, double-masked studies of OTX-101 0.09%, a nanomicellar formulation of cyclosporine A that increases tear production in patients with keratoconjunctivitis sicca (KCS). Study participants used 1 drop per eye of either OTX-101 or vehicle twice daily for 84 days.
The pooled efficacy endpoints of the studies were Schirmer score and change from baseline at day 84, as well as the percentage of patients with ≥10 mm change from baseline at day 84.
The subgroup analyses included 133 assigned to OTX-101 and 113 patients assigned to the vehicle. At baseline, mean Schirmer score was 2.7±1.2 vs 2.5±1.1 for each group. By day 84, mean ± standard error Schirmer score was 8.4±0.7 vs 6.4±0.6 (P =.0294). The percentage of patients with ≥10 mm Schirmer score was 22.6% vs 10.6%; mean standard error change from baseline was 5.5±0.7 vs 3.6±0.6 in each group, respectively.
A safety population of patients included 524 individuals each in the OTX-101 and vehicle groups.
Adverse events were primarily mild, with the most common event being instillation site pain — seen in 21.8% and 4% of patients in each group.
“OTX-101 0.09% administered twice daily for 84 days significantly improves tear production vs vehicle in patients with [keratoconjunctivitis sicca] who have severely impaired tear production,” according to the study. “OTX-101 0.09% was well tolerated.”
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Toyos MM, Gupta PK, Ogundele AB, Karpecki PM. Treatment of patients with Schirmer scores less than 5 mm at baseline with OTX-101: A pooled analysis of phase 2b/3 and phase 3 studies. Poster presented at: 2021 ASCRS Annual Meeting; July 2021; Las Vegas, NV. Abstract 73930.