Last week (September 9 to September 15), a total of 58 varieties passed/were deemed to have passed the consistency evaluation. During the same period, 123 varieties applied for consistency evaluation.
According to the official website of NMPA, Suzhou Ocuvision Biotechnology Co., Ltd. (hereinafter referred to as "Ocuvision")'s cetirizine hydrochloride eye drops obtained a marketing approval on September 10. The drug is indicated for the treatment of itchy eyes associated with allergic conjunctivitis and is suitable for people aged 2 years and above.

Allergic conjunctivitis is an allergic disease of the eye that occurs more frequently in spring and autumn. The disease is mainly manifested by itchy eyes, accompanied by red and swollen eyelids, congestion and edema of the conjunctiva (white eyeballs), increased tears or white secretions, and some patients also have symptoms such as nasal congestion, itchy nose, clear runny nose, and sneezing.

Cetirizine hydrochloride eye drops are one of the commonly used antiallergic eye drops for the treatment of allergic conjunctivitis, and have been identified as a first-line treatment for allergic conjunctivitis by the American Ophthalmology Clinical Guidelines. According to public information, cetirizine hydrochloride eye drops is the first new ophthalmic preparation of the antihistamine cetirizine approved by the FDA, and it is the only ophthalmic antihistamine approved by the FDA for the treatment of children aged 2 years and above.
In April 2023, Ocuvision's cetirizine hydrochloride eye drops (trade name: Zhiweitai®) were filed for production as a Class 3 generic drug; in the same month, the product was included in the priority review and approval process as a "new variety, dosage form and specification of pediatric medicines that meet the physiological characteristics of children" and is suitable for the treatment of eye itching associated with allergic conjunctivitis.
According to Ocuvision, in a Phase III, randomized, blinded, positive-controlled, parallel-group multicenter clinical study of the safety and efficacy of Zhiweitai® in Chinese patients with allergic conjunctivitis, a total of 296 subjects were recruited and found that the change in the patient's most severe eye itching score compared with baseline within 24 hours before the 14th day visit reached the primary efficacy endpoint.

Zhiweitai® is safe and well tolerated, and there is no significant difference in the proportion of patients experiencing adverse events compared with the control drug 0.05% emedastine fumarate eye drops. Zhiweitai® is the first approved generic drug for cetirizine hydrochloride eye drops.

https://news.yaozh.com/archive/44240.html