Harrow and Novaliq GmbH have entered into an agreement for Harrow to acquire the North American (U.S. and Canadian) commercial rights for VEVYE (cyclosporine ophthalmic solution) 0.01% from Novaliq.
Refresh me on VEVYE.
Approved by the FDA in May 2023, VEVYE (pronounced vee-vye) is a cyclosporine formulation solubilized in a novel, water-free excipient—with no antimicrobial preservatives, oils, or surfactants—and designed to specifically meet unfulfilled requirements of DED via topical ophthalmic use..
With no pH or osmolarity characteristics, the product is formulated with EyeSol, Novaliq’s proprietary, preservative- and water-free technology that uses ultrapure semifluorinated alkanes (SFAs).
Click here to learn about its unique benefits.
How does it work?
One drop (10 μL) of the solution is instilled twice a day (BID) in each eye, approximately 12 hours apart.
Within 2 weeks, it can exhibit an increased residual time on the ocular surface and allow for a high bio-availability within the target tissues to release the solution’s fast onset of action.
And the clinical data on it?
Two randomized studies— phase 2/3 ESSENCE-1 trial (NCT03292809) and phase 3 ESSENCE-2 trial (NCT04523129)—found VEVYE (originally developed as CyclASol) to have clinically meaningful therapeutic effects on the ocular surface when compared to vehicle.
And a safety extension trial (ESSENCE-2 OLE) confirmed this data, even reporting improved effects in most sign and symptom endpoints.
Gotcha. Now about this agreement …
The companies aren’t saying too much about the details—and that includes the financials (which were not disclosed).
However, Novaliq CEO Christian Roesky, PhD, stated that the company is looking forward to supporting Harrow during the launch of VEVYE.
Looks like we’ll need to stay tuned for additional info.
So when will VEVYE hit the market?
According to Harrow Chairman and CEO Mark L. Baum, “We look forward to making VEVYE available in the U.S. later this year.”
And the bigger picture?
This latest acquisition is just the latest for Harrow this year—the company also purchased the exclusive U.S. rights to five FDA-approved branded ophthalmics from Novartis (which marked the second deal between the companies in less than a year).
The products included:
- Ilevro (nepafenac ophthalmic suspension) 0.3%
- Nevanac (nepafenac ophthalmic suspension) 0.1%
- Vigamox (moxifloxacin hydrochloride ophthalmic suspension) 0.5%
- Maxidex (dexamethasone ophthalmic suspension) 0.1%
Triesence (triamcinolone acetonide injectable suspension) 40 mg/ml.