Novaliq’s dry eye disease therapy receives US FDA approval

Biopharmaceutical company Novaliq has received approval from the US Food and Drug Administration (FDA) for VEVYE (cyclosporine ophthalmic solution) 0.1% to treat the signs and symptoms of dry eye disease.

VEVYE, the development name of which is CyclASol, is a cyclosporine, solubilised solution in a new, water-free excipient.

It has been designed to address the unmet needs of patients and to provide quick action and well-tolerated dry eye drug therapy.

CyclASol is topical anti-inflammatory and immunomodulating ophthalmic drug solution containing 0.1% cyclosporine A in EyeSol, a unique water-free technology that unlocks the potential of cyclosporine A on the ocular surface.

The water-free formulation of the investigational drug increases residual time on the surface of the eye and improves bioavailability in the target tissues to release the complete potential of cyclosporine A.

Findings from the long-term extension ESSENCE-2 OLE trial showed that CyclASol’s effect was maintained and improved for most endpoints over a treatment period of 52 weeks.

Novaliq medical science and regulatory affairs vice-president Sonja Krösser stated: “We are proud that the FDA approved VEVYE. The safety and efficacy of VEVYE were assessed in a total of 1,369 patients with dry eye disease, of which 738 received VEVYE.

“VEVYE and its novel vehicle were safe, well-tolerated and demonstrated early, consistent and durable therapeutic effects.

“It is an exciting moment when you have followed science that finally led into a new category of water-free ocular therapies addressing unmet medical needs for patients suffering from dry eye disease.”

In May 2023, the company and Bausch + Lomb received approval from the FDA for MIEBO (perfluorohexyloctane ophthalmic solution) for the same indication.