Eyevance secured exclusive U.S. licenses for ZERVIATE™ in September 2017. The two U.S. granted patents provide protection through 2030 and 2032.
ZERVIATE™ is a novel formulation of cetirizine 0.24% ( the active ingredient of the systemic brand Zyrtec®*), an antihistamine. For the first time, this treatment will be available as a topical ocular application for the treatment of ocular itching associated with allergic conjunctivitis.
In approved oral formulations, cetirizine has a well-characterized systemic efficacy and safety profile with worldwide exposure representing 20 years of oral use**.
Two Phase 3 safety and efficacy studies provided statistically significant and clinically relevant results over vehicle control for the primary endpoint of ocular itching in the classical clinical model for the U.S. FDA approval.
- *Zyrtec® is a trademark of UCB Pharma SA or GlaxoSmithKline
- **https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020346, accessed, 10Aug17