Eyevance Pharmaceuticals yesterday has announced the United States launch of ZERVIATE™ (cetirizine ophthalmic solution) 0.24% for the treatment of ocular itching associated with allergic conjunctivitis. ZERVIATE™ is formulated with Hydrella™, the vehicle that contains glycerin and hydroxypropyl methylcellulose (HPMC), two very common ingredients found in tear lubricants; therefore, delivering the cetirizine molecule to the eye with optimal ocular comfort.
The active ingredient in ZERVIATE™ is cetirizine, an antihistamine that is highly selective in blocking the H1 receptor. Cetirizine, in the approved oral formulation - Zyrtec®, binds competitively to histamine receptors to reduce swelling, itching and vasodilation and has a strong safety and efficacy profile with world-wide exposure to millions of patients over 20 years.
In clinical trials, ZERVIATE™ demonstrated rapid onset of action, effectively relieving ocular itching within 3 minutes, as well as more rapid relief of ocular allergic conjunctivitis symptoms than systemic antihistamines. ZERVIATE™ was effective in relieving ocular itching for 8 hours in moderate and severe allergic conjunctivitis patients. ZERVIATE™ also showed an excellent safety profile (ages 2 and up) and was reported to be highly comfortable on instillation. As a topical agent, ZERVIATE™ provides ~100-fold lower systemic exposure than cetirizine tablets8, potentially lowering incidence rates for antihistamine-related systemic side effects (e.g., somnolence, fatigue and dry mouth).
ZERVIATE™ received FDA new drug approval on May 30, 2017. Two Phase 3 studies demonstrated statistically significant and clinically relevant results over vehicle in the reduction of ocular itch in moderate and severe allergic conjunctivitis subjects, and further safety data was collected and evaluated in three additional trials (assessing pharmacokinetics, dosing frequency, and tolerability). In addition, there were numerous ocular and nasal secondary endpoints that were explored.
Full news release: https://www.prnewswire.com/news-releases/eyevance-pharmaceuticals-launches-zerviate-in-the-united-states-301031828.html
Source: Eyevance Pharmaceuticals