Zhaoke Ophthalmology-B (06622): Carbacholine and bromonidine tartrate eye drops (YUVEZZI™) reached the main study end point in a phase II study of Chinese presbyopia patients

Zhitongcaijing · 1d ago

Zhitong Finance App News, Zhaoke Ophthalmology-B (06622) announced that the company's innovative drug, cabacholine and bromonidine tartrate eye drops (YUVEZZI™), has reached a pre-set major research endpoint in a phase II clinical study conducted in China. The treatment is well tolerated and shows good safety characteristics.

The company plans to further discuss with the Drug Evaluation Center of the State Drug Administration to advance phase III clinical trials.

According to reports, the phase II clinical study of carbacoline bromonidine tartrate eye drops in China was a multicenter, randomized, double-blind, crossover, placebo-controlled trial to evaluate the efficacy and safety of BrimocholPF (cabacholine bromonidine tartrate eye drops) and carbacholPF (carbacoline eye drops) in Chinese presbyopia patients. The trial was led by Professor Qu Jia from the Ophthalmology Hospital affiliated to Wenzhou Medical University and conducted at 13 research centers in China. A total of 119 participants were enrolled.

The main study endpoint was the proportion of subjects whose monocular corrected close vision (MCNVA) improved by at least 15 letters compared to the baseline when maintaining monocular corrected distance vision (MCDVA) at the specified evaluation time point; among them, maintaining monocular corrected distance vision was defined as a drop of no more than 5 letters from the baseline.