Harrow Acquires US and Canadian Commercial Rights to Dry Eye Drug Vevye from Novaliq

Harrow has entered the prescription dry eye disease treatment business as it announced a deal to acquire the US and Canadian commercial rights to Vevye (cyclosporine ophthalmic solution 0.1%) from Novaliq. 

Under terms of the deal, Harrow will make an initial payment of $8 million, with one-time future commercial milestone payments and low-double-digit royalties. 

In May, Novaliq received FDA approval for Vevye, which was formerly known as CyclASol, for the treatment of the signs and symptoms of dry eye disease. Novaliq says Vevye is the first and only cyclosporine solution indicated for the treatment of signs and symptoms of dry eye disease with efficacy demonstrated after 4 weeks of treatment.

Vevye is based on Novaliq’s proprietary EyeSol water-free technology. It is dispensed topically in a 10 microliter drop and is labeled for twice‑daily (BID) dosing. The solution does not contain water or anti-microbial preservatives, oils, or surfactants. As a water-free product, there is no associated pH and no osmolarity.

"Vevye is a completely unique product in the market, and we have been serving the dry eye market through our compounded portfolio for a number of years. And in doing so, we've conducted interviews with literally over 800 consumers to really understand why it is that only about one out of every 10 dry eye patients that are on therapy are remaining on therapy at one year. And so it has to do with the adverse event profile of the existing products that are in the market. It has to do with how quickly these products work when patients are suffering, whether they have even mild, but certainly moderate or severe dry eye," Mark L. Baum, Chairman and Chief Executive Officer of Harrow, said in an interview with Eyewire+. "They want something that works quickly and they need something that has a durability of effect. They want it to last a long time. And with Vevye, we found a product that checks all of those boxes. It works rapidly, its adverse event profile is extraordinary, and there is data showing durability of effect out to 1 year."

The NDA for Vevye was supported by safety and efficacy results in over 1,000 patients with DED from a phase 2 dose finding study, the phase 2b/3 ESSENCE-1 study, the phase 3 ESSENCE-2 study, and its open label extension study. CyclASol has demonstrated in two independent adequate and well-controlled, multicenter studies (ESSENCE-1 and ESSENCE-2) clinically meaningful and statistically significant improvements in the indication.

Effects on the ocular surface include a statistically significant reduction in total corneal fluorescein staining (tCFS) score favoring CyclASol in both studies at Days 15 and 29. Up to 71.6% of patients responded within 4 weeks with a clinically meaningful improvement of ≥ 3 grades in total corneal staining. This proportion of responders was significantly higher compared to vehicle-treated patients in both studies. In both studies, compared to vehicle at the end of treatment, there was a statistically significant (P<0.05) higher percentage of patients with increases of 10 mm from baseline in Schirmer’s tear test score at Day 85 and Day 29, respectively, confirming a known effect of the active ingredient cyclosporine. 

The most common adverse reaction observed was instillation site reactions, which was reported in 8.1% of patients in the pooled studies. 

“For patients with chronic and symptomatic dry eye disease, the tolerability profile of the medication can be critical for compliance and treatment success,” Paul Karpecki, OD, director, Cornea and External Disease, Kentucky Eye Institute, and associate professor, University of Pikeville, Kentucky College of Optometry, said in a company news release. “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.”