Phase 2 results for an investigational cyclosporine product specially formulated to improve tolerability shows it significantly improves the signs of dry eye.
Novaliq GmbH formulated CyclaASol using its semifluorinated alkane technology called EyeSol, which allows for a preservative-free, multidose preparation that’s more comfortable for the patient. Formulations based on EyeSol technology are clear, have a refractive index similar to water, and do not cause blurring of vision. They don’t require preservatives because they don’t support microbial growth.
The randomized, double-masked, placebo-controlled, multi-center U.S. study enrolled 207 patients and consisted of 4 treatment groups, including two CyclASol groups (0.05% and 0.1%), an open-label active control and a placebo group.
Both CyclASol groups showed a significant improvement in corneal staining compared with controls and placebo groups over the 4-month treatment period, with improvement seen as early as 14 days after treatment began. The company said that the central area of the cornea appeared to benefit most.
Safety, tolerability and comfort profile were deemed excellent, with 98% of the enrolled patients completing the treatment period. No serious adverse events were reported.
“Consistent improvements in several measures of ocular inflammation of dry eye disease, particularly the improvement in central corneal staining, is a very important feature of the formulation because it positively influences visual function. This, combined with the early onset of action and an excellent tolerability profile, represents a highly relevant improvement over currently available therapies,” said Claus Cursiefen, MD, PhD, FEBO, chairman and professor, Department of Ophthalmology, University of Cologne, and member of Novaliq’s scientific advisory board.