Title of Article: Efficacy and Safety of a Water-Free Topical Cyclosporine, 0.1%, Solution for the Treatment of Moderate to Severe Dry Eye Disease: The ESSENCE-2 Randomized Clinical Trial
What are the key takeaway points from this article?
Dry eye disease (DED) is a common ocular disorder characterized by changes in ocular surface and tear film parameters and symptoms such as eye discomfort and blurred vision. Management of DED depends on the severity and may involve prescription eye drops, cyclosporine, lifitegrast, or short-term corticosteroids. A novel treatment under investigation contains cyclosporine, 0.1%, in a water-free excipient perfluorobutylpentane, which has shown improved bioavailability and efficacy in previous studies. This article presents the results of a phase 3 study (ESSENCE-2) confirming the efficacy, safety, and tolerability of cyclosporine, 0.1%, solution compared to its water-free vehicle for the treatment of signs and symptoms of DED.
The study involved 834 participants and was conducted over 29 days, with the primary efficacy measures being the change from baseline in total corneal fluorescein staining (tCFS) and dryness score. The study revealed that cyclosporine was more effective than the vehicle in reducing tCFS, with a decrease of -4.0 grades compared to -3.6 in the vehicle group. The study also observed that the tCFS responders showed improvements in a variety of symptoms compared with nonresponders. However, there was no significant difference in dryness and blurred vision scores between the cyclosporine and vehicle groups. In a post hoc analysis, the cyclosporine group demonstrated greater reductions in blurred vision scores compared to the vehicle group in the subgroup of participants with high central CFS scores at baseline.
The findings of the ESSENCE-2 randomized clinical trial suggest that a water-free cyclosporine solution is effective in treating ocular surface staining associated with DED, as compared to its vehicle. This treatment may offer faster and more significant improvements in corneal epithelial damage compared to other existing therapies. Nevertheless, further clinical data is needed to better understand the potential of this treatment in practical clinical settings.
Publication Date: April, 2023
Akpek E. K., Wirta D. L., Downing J. E., 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 Ophthalmol [Internet]. 2023 April 6 [cited 2023 April 7]; Available from: https://jamanetwork.com/journals/jamaophthalmology/fullarticle/2803655
Summary By: Alexander Waslen