Harrow Launches Vevye for Dry Eye Disease

Vevye (cyclosporine) 0.1% to treat patients with dry eye disease is now available in the United States. Vevye is a twice-daily water- and preservative-free eye drop to treat the signs and symptoms of dry eye. Cyclosporine is not water-soluble, but the excipient used, perfluorobutylpentane, allows for improved bioavailability and better efficacy.

Vevye was approved by the FDA in May 2023. It was developed by Novaliq, and in July 2023, Harrow acquired the U.S. and Canadian commercial rights to Vevye.

Harrow has established a Vevye Patient Access program where commercially insured patients may receive their first prescription for as low as $0. Additionally, Harrow is providing a money-back guarantee for patients who do not have insurance or who are paying cash for Vevye. Vevye is available through PhilRx, Harrow’s pharmacy partner, as well as through wholesalers McKesson, Cardinal and Cencora. Harrow has partnerships with Apollo Care to manage the copay program and with PARx Solutions to help prescribers manage prior authorizations.

Dry eye is one of the most common ocular surface disorders, with about 18 million Americans diagnosed with dry eye disease.

Related: FDA Approves Novel Cyclosporine for Dry Eye Disease

Vevye’s approval was based on two pivotal studies in more than 2,000 patients. The trials showed that Vevye delivered a fast onset of therapeutic effect, clinical meaningful improvement of ocular surface damage, and tolerability. Effects on the ocular surface include a statistically significant reduction in total corneal fluorescein staining (tCFS) score favoring Vevye in both studies at days 15 and 29. Up to 71.6% of patients responded within four weeks with a clinically meaningful improvement.

“The data in both consecutive registration trials demonstrated impressive efficacy, safety and tolerability, with rapid clinical onset beginning as early as 15 days and continuous improvement for more than one year,” John D. Sheppard, M.D., M.M.Sc., F.A.C.S., an ophthalmologist and founding senior partner of Virginia Eye Consultants in Norfolk, Virginia, said in a press release.