Water-Free Cyclosporine Eye Drop, 0.1 percent, Found Effective for Dry Eye

Water-Free Cyclosporine Eye Drop, 0.1 percent, Found Effective for Dry Eye

April 12, 2023

A water-free cyclosporine solution is proven effective for treating moderate-to-severe dry eye disease (DED), according a study published online in JAMA Ophthalmology.

In this study conducted by Esen K. Akpek, M.D. and colleagues from Johns Hopkins University in Baltimore, the effectiveness of water-free cyclosporine eye drop (0.1%) in treating dry eye disease (DED) was evaluated. The analysis included 834 study participants who were randomly assigned to receive either twice-daily cyclosporine solution or vehicle for a duration of 29 days.

The findings from the study revealed that patients treated with cyclosporine solution had greater improvement in total corneal fluorescein staining (tCFS) than the vehicle group (−4.0 versus −3.6 grades) at day 29 (change [∆], −0.4; 95 percent confidence interval [CI], −0.8 to 0; P = 0.03). Treatment benefits in the dryness score from baseline were seen in both groups: −12.2 points for cyclosporine and −13.6 points for vehicle (∆ = 1.4; 95 percent CI, −1.8 to 4.6; P = 0.38).

The study results also showed that 71.6 percent of participants in the cyclosporine group achieved clinically meaningful reductions of three grades or higher in total corneal fluorescein staining (tCFS), compared to 59.7 percent in the vehicle group. The difference (Δ) in percentage of responders between the two groups was 12.6 percent, with a 95 percent confidence interval (CI) of 6.0 to 19.3 percent and a statistically significant p-value of less than 0.001. Responders in the cyclosporine group also showed greater improvement in symptoms at day 29, including dryness (Δ = -4.6; 95 percent CI, -8.0 to -1.2; P = 0.007) and blurred vision (Δ = -3.5; 95 percent CI, -6.6 to -4.0; P = 0.03), compared to nonresponders.

"The rapid onset and magnitude of improvements on the corneal epithelial damage are potential differentiators to existing therapies," the authors concluded.


Esen K. Akpek et al, Efficacy and Safety of a Water-Free Topical Cyclosporine, 0.1%, Solution for the Treatment of Moderate to Severe Dry Eye Disease, JAMA Ophthalmology (2023). DOI: 10.1001/jamaophthalmol.2023.0709

Andrea Naranjo Lozano et al, Comparison of Water-Free Commercially Available Cyclosporine Ophthalmic Preparations—Different, but the Same, JAMA Ophthalmology (2023). DOI: 10.1001/jamaophthalmol.2023.0850