Harrow Acquires U.S. and Canadian Commercial Rights to VEVYE (Cyclosporine Ophthalmic Solution) 0.1% from Novaliq - Seite 2

“For patients with chronic and symptomatic dry eye disease, the tolerability profile of the medication can be critical for compliance and treatment success,” said Paul Karpecki, O.D., director, Cornea and External Disease, Kentucky Eye Institute, and associate professor, University of Pikeville, Kentucky College of Optometry. “Most patients are not comfortable with drops in their eyes that cause burning or stinging. As a water-free drug product, VEVYE does not require potentially irritating ingredients, such as preservatives, oils or surfactants, and has demonstrated in clinical trials a high patient satisfaction rate. Having a new treatment option with a favorable comfort and tolerability profile is a significant advancement for the dry eye patient, especially those who experience burning and stinging with topical eye medications.”

Christian Roesky, Ph.D., Chief Executive Officer of Novaliq, stated, “We are excited to partner with Harrow, one of the fastest growing and most dynamic ophthalmic pharmaceutical companies in the U.S., to commercialize VEVYE in the U.S. and Canadian markets. Harrow and its commercial team have a distinguished track record for successfully commercializing new and clinically important pharmaceutical products in the U.S. market, and they specifically have many years of experience successfully marketing cyclosporine-based formulations to U.S. eyecare professionals. The Novaliq team looks forward to supporting Harrow during the launch of VEVYE, a truly unique and powerful new treatment option for U.S. eyecare professionals and the more than 16 million Americans who have been diagnosed with DED.”

VEVYE Clinical Data

The safety and efficacy of VEVYE (development name: CyclASol) for the treatment of dry eye disease were assessed in a total of 1,369 patients with dry eye disease, of which 738 received VEVYE.

Study CYS-001 (NCT02113293) was the first-in-human study and was conducted to investigate the safety, tolerability, and pharmacokinetics (PK) in healthy volunteers. In this study, VEVYE was shown to be safe, and no systemic exposure of cyclosporin was observed after ocular administration.

Study CYS-002 (NCT02617667, Wirta et al 2019) demonstrated that VEVYE-dosed patients showed a statistically significant early and clinically meaningful increase in Schirmer’s tear test score at Day 29 compared to vehicle. Additionally, VEVYE showed greater improvement in corneal and conjunctival staining compared to (i) vehicle and (ii) Restasis over the four-month treatment period. The favorable safety and tolerability profile of VEVYE was confirmed.