Novaliq GmbH has received FDA approval for VEVYE (cyclosporine ophthalmic solution) 0.1%, indicated for the treatment of the signs and symptoms of dry eye disease (DED).
Tell me more about VEVYE.
Developed under the name CyclASol, 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.
With no pH or osmolarity characteristics, the calcineurin inhibitor immunosuppressant is meant for topical ophthalmic use.
Talk about this water-free component.
VEVYE is formulated with EyeSol, Novaliq’s proprietary, preservative- and water-free technology that uses ultrapure semifluorinated alkanes (SFAs).
According to the company, these SFAs have very low surface tension and viscosity, dispense low-volume drops (<12 µL) that do not stimulate blinking or reflex tearing, and have the same refractive index as water.
And how does this benefit VEVYE?
By having low surface and interface tension, the drops are able to spread rapidly over the ocular surface and form a flat, transparent layer that could allow for improved visual clarity—without potential blurring.
What’s the recommended dosage?
Per its prescribing information, one drop of VEVYE can be instilled twice a day (BID) in each eye, approximately 12 hours apart.
See here for the full details.
How does it work?
After drops are administered, VEVYE 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 within 2 weeks.
Any clinical data to back the approval up?
Yup! The randomized, multicenter phase 2/3 ESSENCE-1 trial (NCT03292809) and phase 3 ESSENCE-2 trial (NCT04523129) both concluded that the use of VEVYE (then CyclASol) led to clinically meaningful early therapeutic effects on the ocular surface when compared to vehicle.
And the multicenter, open-label, single-arm, 12-month safety extension trial (ESSENCE-2 OLE) confirmed the effects of CyclASol were maintained and, in some cases, even improved for most sign and symptom endpoints.
Significance?
With this approval, VEVYE is now the first and only cyclosporine solution indicated for the treatment of signs and symptoms of DED, with an efficacy demonstrated over 4 weeks.
What else to know?
This latest approval marks the second for Novaliq is less than a month: the company, in partnership with Bausch + Lomb, received FDA approval in May 2023 for MIEBO (perfluorohexyloctane ophthalmic solution) for the treatment of signs and symptoms associated with DED.
Click here for the details.