Novaliq has enrolled a total of 834 participants to participate in the second of two Phase 3 (ESSENCE-2) studies, evaluating the investigational drug CyclASol to treat the signs and symptoms of dry eye disease (DED).
The Phase 3 program for the unique EyeSol water-free technology, includes a completed multi-centre, randomised, double-masked, vehicle-controlled trial in 328 patients (ESSENCE-1), and an ongoing multi-centre, open-label, single-arm 12-month safety extension trial in 202 patients (ESSENCE-2 OLE). Results from ESSENCE-2 are expected in Q4 2021 and, if positive, will allow for a New Drug Application (NDA) filing to the U.S Food and Drug Administration in 2022.
If approved, CyclASol may offer a first-in-time anti-inflammatory treatment for the signs and symptoms of dry eye disease with an early onset of action, high efficacy and good tolerability
“We are very pleased with the progress of the Phase 3 program for CyclASol and thank the patients, study sites and investigators who participate in this program. We are hopeful the results of the ESSENCE-2 study will be consistent with the results of the ESSENCE-1 trial and confirm efficacy and safety results from the earlier phases of the development program,” said Sonja Krösser, Ph.D., Vice President Pre-Clinical and Clinical Development, Novaliq.
CyclASol is a topical, anti-inflammatory and immunomodulating ophthalmic solution, containing 0.1% cyclosporine A in EyeSol, developed for the treatment of DED. The unique water-free drug product is based on the EyeSol enhanced ocular bioavailability technology that allows for several fold higher corneal penetration of cyclosporine A in comparison to water or oil-based formulations.1 This has led to the differentiated therapeutic profile of CyclASol with an early onset of efficacy within two weeks and significantly improved tolerability.
“If approved, CyclASol may offer a first-in-time anti-inflammatory treatment for the signs and symptoms of dry eye disease with an early onset of action, high efficacy and good tolerability,” said Christian Roesky, CEO, Novaliq. “We anticipate to submit a New Drug Application for CyclASol to the U.S. Food and Drug Administration in 2022.”
1. Agarwal P et al. Semifluorinated alkane based systems for enhanced corneal penetration of poorly soluble drugs. International Journal of Pharmaceutics 538 (2018) 119-129