Novaliq Announces Over 50% Patient Recruitment in Phase 3 Trial for CyclASol® in Dry Eye Disease and Files Prospectus

Heidelberg, Germany and Cambridge, Massachusetts, USA, April 29, 2021 /PRNewswire/ -- Focused on unique EyeSol-based^®Novaliq, a leading and best-in-class ophthalmic therapeutic biopharmaceutical company utilizing anhydrous technology, today announced the evaluation of CyclASol^®More than 50% of the 834 target patients have been randomized in the second Phase 3 clinical trial evaluating the signs and symptoms of dry eye disease (DED), with top-line results expected to be announced in the second half of 2021.

CyclASol^®The Phase 3 program includes the completed multicenter, randomized, double-blind, vehicle-controlled trial in 328 patients (ESSENCE-1), the ongoing Phase 3 trial (ESSENCE-2) designed to reconfirm the efficacy results of ESSENCE-1, and a multicenter, open-label, single-arm 12-month safety extension trial (ESSENCE-2 OLE). If the ESSENCE-2 results are positive, a New Drug Application (NDA) can be submitted to the U.S. Food and Drug Administration in 2022.

Dr. Sonja Krösser, Vice President of Clinical Development at Novaliq, stated, “Despite the impact of the COVID-19 pandemic, we successfully ensured robust enrollment in the ESSENCE-2 trial through careful selection and support of clinical research sites. Patients had the opportunity to participate in the open-label 12-month safety extension study, and we are pleased to report that enrollment in the ESSENCE-2 OLE trial has been completed, with a total of 200 participants. The achievement of these two enrollment milestones demonstrates that we are proceeding according to CyclASol^®Development plan is underway, and we will submit our first NDA in 2022.”

CyclASol^®is a topical anti-inflammatory and immunomodulatory ophthalmic solution, in EyeSol^®contains 0.1% cyclosporine A (developed for the treatment of DED). This unique anhydrous formulation is based on EyeSol^®Based on enhanced ophthalmic bioavailability technology, the corneal penetration rate of Cyclosporine A is several times higher than that of water-based or oil-based formulations.^[1]This can produce CyclASol.^®Differentiated therapeutic efficacy, with early onset of action within 2 weeks and significantly improved tolerability.

The previous Phase 2b/3 clinical trial, ESSENCE-1, evaluated CyclASol^®Efficacy, Safety, and Tolerability in Patients with Dry Eye Disease (DED): The Trial Has Been Published in *Cornea: Journal of Corneal and External Diseases*^[2]. In this study, CyclASol^®Compared with the vehicle group at 4 weeks, statistically significant improvements were demonstrated in the prespecified endpoints for signs and symptoms of DED. CyclASol^®Compared with the earlier Phase 2 trial^[3]consistent with the results, compared to its vehicle group, there were clinically meaningful improvements in corneal and conjunctival staining for monitoring ocular surface conditions, as well as improvements in dryness symptoms. Furthermore, the ESSENCE–1 trial demonstrated that reading speed improved alongside reductions in corneal staining. The safety and tolerability profile of the trial was excellent, with outstanding scores for application comfort, a benefit typically reported only with lubricating eye drops.^[2]。

The ongoing ESSENCE-2 trial is a multicenter, randomized, double-blind, vehicle-controlled clinical study to evaluate CyclASol^®Efficacy, safety, and tolerability in treating the signs and symptoms of DED. The trial plans to enroll approximately 834 subjects across 25 clinical centers in the United States. The primary endpoint is the change from baseline in total corneal staining and ocular dryness scores on Day 29. The trial will again include an assessment of reading speed as an objective and quantitative measure of visual function. The company expects to announce the top-line data from ESSENCE-2 in the second quarter of 2021.

Dr. Christian Roesky, CEO of Novaliq, stated: “We extend our sincere gratitude to all patients, investigators, and local site staff who participated in this study, as well as to the entire development teams in the United States and Heidelberg, for their dedication and hard work in achieving this important milestone, particularly amidst the added complexities posed by the COVID-19 pandemic.”