Results from Phase III ESSENCE-2 trial for CyclASol in dry eye disease published in JAMA Ophthalmol

CyclASol is currently under regulatory review for the treatment of signs and symptoms of dry eye disease (DED). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of June 8, 2023.

The publication titled “Efficacy and Safety of a Water-Free Topical Cyclosporine 0.1% Solution for the Treatment of Moderate to Severe Dry-Eye Disease: ESSENCE-2, a Randomized Clinical Trial” reported that CyclASol shows early therapeutic effects on the ocular surface. This study evaluated corneal staining responders to get a better understanding of how many patients benefit from the treatment. An at least 3 score improvement of corneal staining on the National Eye Institute (NEI) scale is an immediately noticeable and clinically meaningful response of a dry eye disease therapy.

In ESSENCE-2, 71.6% of CyclASol treated patients showed such a response after 4 weeks of treatment, significantly more than in the vehicle group. Notably, the study showed that a minimum of 3 score of corneal staining improvement was associated with significant improvements in a variety of patient reported symptoms, establishing a correlation between the magnitude of improvement in the physician-measured clinical signs and the patient-reported symptoms.

See: “Efficacy and Safety of a Water-Free Topical Cyclosporine 0.1% Solution for the Treatment of Moderate to Severe Dry-Eye Disease: ESSENCE-2, a Randomized Clinical Trial” Esen K. Akpek et al. JAMA Ophthalmol. Published online April 6, 2023. doi:10.1001/jamaophthalmol.2023.0709