FDA Approves New Formulations: ZERVIATE, The First Topical Ophthalmic Formulation
On May 30, 2017, the U.S. Food and Drug Administration (FDA) approved the first topical eye preparation (ZERVIATE, cetirizine hydrochloride eye drops) for the antihistamine cetirizine for the treatment of Allergic conjunctivitis associated itchy eyes.
Cetirizine hydrochloride was developed by Johnson & Johnson and was approved by the U.S. Food and Drug Administration (FDA) on December 8, 1995 under the trade name Zyrtec in tablet form.
Cetirizine hydrochloride piperazine derivative, which is the metabolite of hydroxyzine, but also a certain stability of mast cell activity, long-acting, non-sedating antihistamines. Is the second generation of H1 antihistamines, long-acting selective oral potent anti-allergic drugs. Commonly used in seasonal or perennial allergic rhinitis, caused by allergens urticaria and itchy skin.
The drug is usually administered orally in doses of 10 mg once daily or 5 mg twice daily, although in the United States, 5 mg daily is sometimes used as the starting dose. The drug can also be decongestant drugs (such as pseudoephedrine hydrochloride) combined. It is less likely to cause drowsiness at the usual doses and has almost no anti-muscarinic activity.
In China, cetirizine hydrochloride is converted from prescription drugs to over-the-counter medicines starting January 11, 2008. Domestic only oral dosage form listed.
ZERVIATE by the French company NICOX research and development.
ZERVIATE (cetirizine hydrochloride ophthalmic solution) for the sterile ophthalmic preparations, specifications for 0.24%, each containing cetirizine 2.40 mg (equivalent to 2.85 mg cetirizine hydrochloride), excipients consisting of: benzaldehyde Ammonium chloride 0.010% (preservative); glycerin; disodium hydrogen phosphate; EDTA-2Na; polyethylene glycol 400; polysorbate 80; hypromellose; hydrochloric acid / sodium hydroxide . The ZERVIATE solution has a pH of about 7.0 and an osmotic pressure of about 300 mOsm / kg.
Packaging specifications: 5mL / bottle; 7.5mL bottle
The efficacy of Zerviate has been demonstrated in three randomized, double-blind, placebo-controlled, conjunctival antigen challenge clinical trials in patients with a history of allergic conjunctivitis. In two trials evaluating the onset and duration of the effect, Zerviate showed a statistically and clinically significant reduction of ocular pruritus 15 and 8 hours after treatment compared to vehicle. Zerviate recommended dose of 1 drop, 2 times a day, an interval of about 8 hours.
The most commonly reported adverse reactions were ocular congestion, pain in the drip site and decreased visual acuity, which occurred in about 1% to 7% of patients treated with Zerviate or vehicle in clinical trials.
Michael Bergamini, Nicox Chief Scientific Officer and Executive Vice President, commented: "Today, ZERVIATE's approval demonstrates the expertise and unwavering commitment of our team to bring new ophthalmic treatment options to patients. We would like to thank both internally and externally Outstanding team for this project. "
Nicox R & D pipeline