Abstract
Purpose :
The COSMO study aimed to evaluate the efficacy and safety of a novel 0.05% Cyclosporine Ophthalmic Gel compared with vehicle in the treatment of patients with moderate to severe dry eye disease (DED).
Methods :
After a 14-day open-label placebo run in period, 644 eligible subjects were randomized 1:1 to receive treatment with either 0.05% Cyclosporine Ophthalmic Gel or vehicle nightly for 84 days. Evaluation was carried out on baseline, day 14, 42 and 84 consisting of objective measures including corneal and conjunctival staining, Schirmer test and Tear Break Up Time (BUT) and subjective measures including Eye Dryness Score (EDS) and 6 other symptoms using visual analog scale (VAS). The primary efficacy endpoint was the proportion of patients with a ≥1-point decrease in inferior corneal fluorescein staining score (ICSS) from baseline on day 84. Secondary efficacy endpoints evaluated mean change from baseline to day 14, 42 and 84 including VAS scores for EDS and 6 other dry eye symptoms (burning/pinching sensation, itching, foreign body sensation, discomfort, photophobia, and pain), ICSS score, corneal and conjunctival staining rating (Oxford grading), Schirmer test value and BUT score.
Results :
The study met the primary efficacy endpoint of a ≥1-point decrease in ICSS in 73.7% of the treatment group vs 53.2% of vehicle group (P<0.0001) at day 84. The treatment group showed statistically greater improvement of both ICSS scores and corneal conjunctival staining score over vehicle group on day 14 (P=0.0011; P=0.038), day 42(P<0.0001; P=0.021) and day 84(P<0.0001; P=0.008). Significant improvement in tear secretion was also observed at day 14(P=0.024) and day 84(P=0.005). The EDS scores and stability of tear film (BUT score) at each visit improved significantly relative to baseline, however no significant difference between groups was observed.
Conclusions :
0.05% Cyclosporine Ophthalmic Gel once a day significantly reduced corneal and conjunctival staining and improved tear secretion compared with vehicle in moderate to severe DED. It also significantly alleviated symptoms compared with baseline. 0.05% Cyclosporine Ophthalmic Gel will be a new efficacious, safe and well tolerated therapeutic option that might bring additional benefits of convenience and compliance as a once-a-day treatment for moderate to severe dry eye.
This abstract was presented at the 2022 ARVO Annual Meeting, held in Denver, CO, May 1-4, 2022, and virtually.