A significantly higher percentage of patients with dry eye disease treated with OTX-101 experienced significant improvements in tear production and ocular surface integrity than patients treated with vehicle.
A randomized, multicenter, double-masked, vehicle-controlled phase 3 study included 744 patients with a history and clinical diagnosis of dry eye disease. Researchers evaluated the safety and efficacy of Cequa (OTX-101; cyclosporine ophthalmic solution 0.09%, Sun Pharmaceutical Industries) for the treatment of dry eye in 371 patients compared with 373 patients who received vehicle. The primary endpoint was the proportion of eyes with improvement in Schirmer test scores at day 84.
Seven hundred eight patients completed all study visits. At baseline, mean Schirmer test score was 11.9 mm in the OTX-101 group and 12.1 mm in the vehicle group. At 84 days, a higher percentage of eyes in the OTX-101 group, 16.6%, experienced a clinically meaningful increase of 10 mm or more on Schirmer test as compared with the vehicle group, 9.2% (P < .001).
Additionally, a significantly greater improvement in conjunctival staining was observed in the OTX-101 group at days 56 and 84 compared with the vehicle group and in corneal staining at days 28, 56 and 84. – by Robert Linnehan
Disclosures: Goldberg reports he receives financial support from Sun Pharma and Ocular Science. Please see the study for all other authors’ relevant financial disclosures.