Zhaoke Ophthalmology’s YUVEZZI™ Hits Primary Endpoint in China Phase II Presbyopia Trial

Bulletin Express
Sep 04

Zhaoke Ophthalmology Limited announced that its innovative eye-drop therapy, YUVEZZI™ (a fixed-dose combination of carbachol and brimonidine tartrate), achieved the prespecified primary endpoint in a Phase II clinical study involving Chinese patients with presbyopia.

The multicenter, randomized, double-blind, crossover, placebo-controlled trial enrolled 119 participants across 13 sites and was led by Professor Qu Jia of the Eye Hospital of Wenzhou Medical University. The primary endpoint measured the proportion of subjects attaining an improvement of at least 15 letters from baseline in monocular corrected near visual acuity while sustaining no more than a five-letter loss in monocular corrected distance visual acuity. YUVEZZI™ demonstrated efficacy on this endpoint and exhibited a favorable safety and tolerability profile.

Following the positive outcome, Zhaoke Ophthalmology plans to engage the Center for Drug Evaluation of China’s National Medical Products Administration to advance the program into Phase III development.

YUVEZZI™ is a once-daily, preservative-free, pupil-modulating eye drop that can be stored at room temperature. Licensed from U.S. partner Tenpoint Therapeutics Ltd., the product combines carbachol, a cholinergic agent, with brimonidine tartrate, an α2-adrenergic receptor agonist, to induce pupil constriction and enhance near and intermediate vision via a pinhole effect. The formulation received U.S. FDA approval in January 2026 and has also been cleared for use by regulators in Hainan and Macau.

Zhaoke Ophthalmology cautioned that successful commercialization of YUVEZZI™ is not guaranteed and advised shareholders and potential investors to exercise caution when dealing in the company’s shares.

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