Novaliq Provides Development Update on CyclASol® Topical Ophthalmic Solution for the Treatment of Dry Eye Disease
- CyclASol® has the potential to change the way eye care practitioners treat patients with dry eye disease
- EyeSol®, the unique water-free technology, unfolds the full potential of cyclosporine A on the ocular surface with an unprecedented tolerability profile
- Novaliq agreed with the U.S. Food and Drug Administration (FDA) that the second registrational trial, ESSENCE-2, is expected to complete the clinical development of CyclASol®
- ESSENCE-2 is a multicenter, randomized, double-masked, vehicle-controlled clinical trial expected to start in the second half of 2020
Novaliq GmbH, a pharmaceutical company focusing on first- and best-in-class ocular therapeutics, today provided a development update on its investigational water-free and preservative-free drug CyclASol®.
CyclASol® is a topical anti-inflammatory and immunomodulating ophthalmic solution, containing 0.1% cyclosporine A in EyeSol®, developed for the treatment of dry eye disease. The unique water-free formulation increases residual time on the ocular surface and enables a high bio-availability in the target tissues to unfold the full potential of cyclosporine A. The multi-dose, preservative-free, smaller and more physiologic droplet size profile provides unique clinical benefits and outstanding tolerability. Notably, the improvement in visual function associated with a clinically significant reduction of corneal staining, as shown in the recent Phase 2/3 clinical ESSENCE-1 trial, will differentiate CyclASol® from existing therapies.