Zerviate Approval History
Reviewed on May 31, 2017 by J.Stewart BPharm.
- FDA approved: Yes (First approved May 30th, 2017)
- Brand name: Zerviate
- Generic name: cetirizine hydrochloride
- Dosage form: Ophthalmic Solution
- Company: Nicox Ophthalmics, Inc.
- Treatment for: Conjunctivitis, Allergic
Zerviate (cetirizine hydrochloride) is a histamine-1 (H1) receptor antagonist ophthalmic formulation for the treatment of ocular itching associated with allergic conjunctivitis.
The approval of Zerviate was based on efficacy data from three randomized, double-masked, placebo-controlled clinical trials in patients with a history of allergic conjunctivitis. Zerviate demonstrated statistically and clinically significantly less ocular itching compared to vehicle at 15 minutes and 8 hours after treatment.
Zerviate is an ophthalmic solution administered as a single drop into the affected eye twice daily. Common side effects include eye redness (ocular hyperemia), pain at instillation site, and reduced clarity of vision (visual acuity).
Development History and FDA Approval Process for Zerviate
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