Ocumension‘s Anti-Allergy Eye Drug Approved for Marketing in China

  According to the official website of NMPA, Cetirizine Hydrochloride Eye Drops from Suzhou Ocumension  Biotechnology Co. It is used for the treatment of itchy eyes associated with allergic conjunctivitis and is suitable for people aged 2 years and above.

  Cetirizine hydrochloride eye drops is one of the commonly used anti-allergic eye drops for the treatment of allergic conjunctivitis, and has been clearly identified as the first-line treatment option for allergic conjunctivitis by the U.S. Ophthalmology Clinical Guidelines. According to publicly available information, Cetirizine Hydrochloride Eye Drops is the first FDA-approved novel ophthalmic formulation of the antihistamine cetirizine, and is the only ophthalmic antihistamine approved by the FDA for use in the treatment of young children 2 years of age and older.

  In April 2023, Ocumension‘s Cetirizine Hydrochloride Eye Drops (trade name: Zerviate®) was submitted for production as a Generic Category 3; in the same month, the product was included in the priority review and approval process as a “new variety, dosage form, and specification of children‘s drug that conforms to children‘s physiological characteristics,” and it is indicated for the treatment of itchy eyes associated with allergic conjunctivitis.

  Zerviate® is the first generic version of cetirizine hydrochloride eye drops to be approved.

  In the Phase III, randomized, blinded, positively controlled, parallel-group, multicenter clinical study of the safety and efficacy of Zerviate® in Chinese patients with allergic conjunctivitis, the trial recruited a total of 296 subjects and found that the change in patients‘ worst itchy eye scores from baseline in the 24 hours prior to the Day 14 visit met the primary efficacy endpoint, according to Ocwenview.

  Zerviate® was safe and well tolerated, with no significant difference in the proportion of patients experiencing adverse events compared to the control drug, 0.05% emetine fumarate eye drops.