The U.S. Food and Drug Administration (FDA) has approved cetirizine ophthalmic solution 0.24% (Zerviate) to treat ocular itching associated with allergic conjunctivitis.
Zerviate is the first topical ocular formulation of the antihistamine cetirizine, which is already approved for oral use. Dosage is one drop in affected eye twice a day.
“Receiving approval from the U.S. FDA for Zerviate is a huge milestone for Nicox and partnering discussions are underway for U.S. commercialization rights,” said Michele Garufi, Chairman and Chief Executive Officer of Nicox in a press release.
Approval was granted to the French ophthalmic R&D company Nicox three months ahead of its PDUFA date of September 8, 2017.
The efficacy of Zerviate was established in three randomized, double-masked, placebo-controlled, conjunctival antigen challenge (Ora-CAC model of allergic conjunctivitis) clinical trials in patients with a history of allergic conjunctivitis. Onset and duration were evaluated in two of these trials in which Zerviate demonstrated statistically and clinically significantly less ocular itching compared to the control group at 15 minutes and 8 hours after treatment.
The most commonly reported adverse reactions—ocular hyperemia, instillation site pain, and reduction in visual acuity—occurred in approximately one to seven percent of patients treated with either Zerviate or control.
Cetirizine, the active ingredient in Zyrtec, is a second generation antihistamine (H1 receptor antagonist) that binds competitively to histamine receptor sites to reduce swelling, itching and vasodilation. It has a well-characterized systemic efficacy and safety profile.
With this approval—the first approved New Drug Application for the company—and a promising pipeline of candidates, Nicox is poised to become a leader in the ophthalmic space. The company is developing an extensive portfolio of novel therapies that target multiple ophthalmic conditions. Phase II studies are planned for its blepharitis drug in Q4 2017 and it glaucoma drug in Q1 2018.
“We expect to further solidify our position as a leading ophthalmic R&D company with the anticipated FDA decision on VyzultaTM2, which is licensed worldwide to Bausch + Lomb, and the expected commencement of Phase 2 clinical trials for both NCX 4251 and NCX 470. This is an exciting time for Nicox, and we look forward to keeping you updated on our progress.”
Filed Under: Drug Discovery