Novaliq completes enrollment in second Phase 3 study of candidate to treat dry eye

Novaliq has announced the second of two Phase 3 (ESSENCE-2) studies, evaluating topical cyclosporine(CyclASol, Novaliq) to treat the signs and symptoms of dry eye disease (DED), has been completely enrolled with a total of 834 participants.

Dry eye disease, one of the most common ocular surface disorders, impacts quality of life for millions of people. Although a multifactorial chronic disease, inflammation and immunologic processes play a key role in the pathology of dry eye. Infiltration of immune cells in the lacrimal glands, meibomian glands, conjunctiva, and cornea are dominating characteristics in dry eye disease.

The inflammatory vicious cycle includes tear film instability, tear hyperosmolarity, apoptosis of corneal/conjunctival cells, inflammation in the ocular surface and ocular damage. Intrinsic and extrinsic factors cause stress to the ocular surface, which accelerates the cycle and, in turn, exacerbates dry eye.1

The Phase 3 program for cyclosporine also includes a completed multi-center, randomized, double-masked, vehicle-controlled trial in 328 patients (ESSENCE-1), and an ongoing multi-center, open-label, single-arm 12-month safety extension trial in 202 patients (ESSENCE-2 OLE).

Results from ESSENCE-2 are expected during the fourth quarter of 2021 and, if positive, will allow for a New Drug Application (NDA) filing to the FDA in 2022.

"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,” Sonja Krösser, PhD, the vice president of pre-clinical and clinical development at Novaliq, said in a statement. “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.”

According to the company, the 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.2 This has led to the differentiated therapeutic profile of cyclosporine with an early onset of efficacy within 2 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," Christian Roesky, CEO of Novaliq, said in a statement.