GRANDPHARMA: The Phase IIa clinical study of the global innovative ophthalmic drug GPN00884 has completed the enrollment of its first patient in China
GRANDPHARMA announced that the first patient has been enrolled in the Phase IIa clinical study of its global innovative ophthalmic drug GPN00884 in China. The study aims to evaluate the efficacy and safety of GPN00884 eye drops in slowing the progression of myopia in children, with plans to recruit 80 myopic patients aged 6 to 12 years. GPN00884 has a new mechanism that avoids the side effects of low-concentration atropine, meeting the clinical needs for the treatment of myopia in children in China. This study marks an important advancement for the company in the field of ophthalmology
According to the Zhitong Finance APP, GRANDPHARMA (00512) announced that the global innovative ophthalmic drug GPN00884, used to delay the progression of myopia in children, has recently completed the enrollment of its first patient in the Phase IIa clinical study conducted in China. This study is a randomized, double-blind, placebo-controlled Phase IIa clinical trial, aiming to enroll more than 80 myopic subjects aged 6 to 12 years, with the goal of preliminarily evaluating the efficacy of GPN00884 eye drops in delaying the progression of myopia in children and its safety in pediatric myopic patients.
GPN00884 eye drops are an innovative drug with a new mechanism of action for delaying the progression of myopia in children. Compared to low-concentration atropine eye drops, GPN00884 eye drops do not cause pupil dilation effects and do not lead to adverse reactions such as photophobia or decreased accommodation. The administration period is not restricted, which can improve patient compliance. Currently, there is a lack of drugs with clear efficacy and safety for delaying the progression of myopia in children in China, and there is an unmet clinical need in this disease area. GPN00884 eye drops are expected to provide a new clinical treatment option for doctors and patients to delay the progression of myopia in children.
Previously, GPN00884 eye drops were approved to conduct Phase I clinical research in China in March 2024, and all subjects were enrolled by August of the same year. The Phase I clinical study was completed in March 2025, and the results showed that GPN00884 had good safety and tolerability after single and multiple doses in healthy subjects, exhibiting linear pharmacokinetic characteristics. The enrollment of the first patient in this Phase IIa clinical study marks another significant milestone in the Group's ophthalmology direction within the otorhinolaryngology sector
