Novaliq announced that it has begun randomization of patients in its ESSENCE phase 2b/3 clinical trial that will evaluate CyclASol for the treatment of the signs and symptoms of dry eye disease (DED).
CyclASol is a preservative free ophthalmic solution of cyclosporine A in EyeSol, Novaliq’s proprietary and first and only water-free technology. Excellent safety and tolerability of CyclASol as well as the ability to improve signs and symptoms of DED with an early onset of effect have been demonstrated in a previous phase 2 study. The results of this phase 2 study are being presented [PO059] at AAO 2017, which takes place November 11-14, 2017 in New Orleans. CyclASol potentially overcomes the current intolerability and efficacy profiles due to the benefits of a water-free vehicle and the mechanism of drug delivery.
“Medications with highly favorable tolerability profiles and early onset of action are an unmet medical need in dry eye disease,” John Sheppard, MD, Professor of Ophthalmology, Eastern Virginia Medical School, said in a company news release. “Based on the very promising data from the CyclASol phase 2 study, we are excited to participate in the ESSENCE trial, thereby moving this promising product closer to the market.”
Novaliq’s ESSENCE 2b/3 clinical trial (NCT03292809) is a randomized, double-masked, vehicle-controlled, multi-center trial, designed to evaluate the safety, efficacy and tolerability of topical CyclASo for the treatment of DED. Study patients will be randomized to one of two treatment groups: CyclASol and vehicle. ESSENCE has a primary efficacy endpoint at 4 weeks with continued dosing for safety evaluation over a total of 3 months. The study is being conducted in approximately 10 sites in the U.S., with a total planned enrollment of approximately 316 patients.
“The initiation of this phase 2b/3 trial of the CyclASol program is a major milestone in advancing our clinical development of CyclASol,” Sonja Krösser, PhD, VP Clinical Development at Novaliq GmbH, said in a company news release. “This pivotal trial design has been based on sound prior data demonstrating superior reduction of corneal and conjunctival staining as well as OSDI of CyclASol over its vehicle in the population selected for ESSENCE. This trial is designed to support planned regulatory applications worldwide, including the United States, Europe and Japan."