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

Harrow (Nasdaq: HROW), a leading U.S. eyecare pharmaceutical company, and Novaliq GmbH, a German biopharmaceutical company focusing on first- and best-in-class ocular therapeutics, today announced an agreement under which Harrow will acquire the U.S. and Canadian commercial rights for VEVYE (cyclosporine ophthalmic solution) 0.1%, a patented, non‑preserved, ophthalmic solution prescription drug based on Novaliq’s proprietary EyeSol water-free technology. VEVYE, which is dispensed topically in a unique 10 microliter per one drop and is labeled for twice‑daily (BID) dosing, is the first and only cyclosporine-based product indicated for the treatment of both signs and symptoms of dry eye disease (DED). VEVYE was approved on May 30, 2023, by the U.S. Food and Drug Administration (FDA).

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In commenting on the transaction, Mark L. Baum, Chairman and Chief Executive Officer of Harrow, said, “The acquisition of the U.S. and Canadian commercial rights to VEVYE demonstrates our commitment to the highly underserved dry eye and ocular surface inflammation markets. We are particularly excited about adding VEVYE to our portfolio because of our strong belief that the U.S. DED market is in need of a cyclosporine‑based product that is generally well tolerated, improves both the signs and symptoms of DED and, critically, reduces the time it takes for patients to experience relief from this all-too-common and, in many cases, debilitating disease. VEVYE not only feels better in the eye, but it performs differently, and we believe it addresses the numerous unmet needs in the large and growing U.S. DED market. We look forward to making VEVYE available in the U.S. later this year.”

“There’s good news for dry eye patients and for our colleagues,” commented Laura M. Periman, M.D., Director of Dry Eye Services and Clinical Research, Periman Eye Institute, in Seattle, Washington. “VEVYE, which is expected to be available soon, is a unique cyclosporine formulation indicated for treatment of the signs and symptoms of DED. The rapid onset and magnitude of improvements on ocular surface epithelial damage, combined with the tolerability of the non-aqueous vehicle, are key differentiators to existing cyclosporin formulations. These features represent an exciting advancement in addressing the medical needs of dry eye patients and clinicians.”