Novaliq Announces First Patient Randomized in the ESSENCE-2 Phase 3 Trial of Dry Eye Treatment CyclASol
Novaliq announced that it has initiated the randomization of patients in its phase 3 clinical trial ESSENCE-2 that is designed to replicate efficacy results of the previous phase 2/3 ESSENCE-1 trial.
“The initiation of this second registrational trial represents a key milestone for both CyclASol and our company,” Sonja Krösser, PhD, Vice President Clinical Development at Novaliq, said in a company news release. “Our program has been agreed upon by the U.S. Food and Drug Administration. If ESSENCE-2 is successful, we will have sufficient clinical evidence to support a new drug application for CyclASol for the treatment of the signs and symptoms of dry eye disease in 2022.”
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 water-free formulation has led to a differentiated therapeutic profile with an early onset of efficacy and improved tolerability for patients with dry eye disease. The previous phase 2/3 clinical trial ESSENCE-1 demonstrated statistically significant improvements with CyclASol in both sign and symptom endpoints as compared to its vehicle after 4 weeks. Additionally, the trial demonstrated that reading speed improves with corneal staining reduction. Safety and tolerability in the trial were excellent. [1]
The ESSENCE-2 trial is a multicenter, randomized, double-masked, vehicle-controlled clinical trial to assess efficacy, safety and tolerability of CyclASol for the treatment of signs and symptoms of dry eye disease. The trial is planned to enroll approximately 834 subjects in about 25 U.S. clinical centers and is being conducted by Ora Inc.. The prespecified primary endpoints of the trial are the change from baseline in total corneal staining and in eye dryness score at day 29. The trial will include the assessment of reading speed as an objective and quantifiable measurement of visual function. About 200 patients will be rolled over in an open-label extension trial to assess the long-term safety over a period of one year. The company expects to publish topline data from ESSENCE-2 in the 2nd half of 2021.
Due to potential delays caused by COVID-19, the company is not providing a target date for the ESSENCE-2 topline results. Although Novaliq and Ora currently do not anticipate delays to the clinical timelines, the companies will closely monitor the situation during the trial and provide regular information on development timelines.
“The pronounced effects on corneal staining resulting in improvement in visual function and the excellent tolerability profile seen with CyclASol addresses an important medical need for patients with chronic dry eye disease,” Laura Periman, MD, Founder and Director of Dry Eye Services and Clinical Research at Periman Eye Institute, said in the news release. “We are excited to participate in ESSENCE-2, thereby bringing this promising product candidate one step further to patients suffering from predominately aqueous deficient dry eye disease.”