GRANDPHARMA's global innovative ophthalmic drug GPN00833 has completed domestic Phase III clinical research and achieved clinical endpoints

According to the Zhitong Finance APP, GRANDPHARMA (00512) announced that its hormone nano-suspension eye drops GPN00833 for postoperative anti-inflammatory analgesia in ophthalmology have recently completed Phase III clinical trials conducted in China and successfully achieved clinical endpoints, marking another significant milestone in the group's progress in the field of ophthalmology.

It is reported that GPN00833 is an anti-inflammatory analgesic hormone nano-suspension eye drop, with its main active ingredient being clobetasol propionate, a potent glucocorticoid with effective local anti-inflammatory activity and strong vasoconstrictive effects. Additionally, its unique nano-formulation technology effectively addresses the low bioavailability and safety risks associated with the low water solubility of hormone products. The product was approved in April 2023 in China to conduct a multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase III clinical study, enrolling 255 patients who underwent cataract surgery, randomly assigned in a 2:1 ratio to the study drug group and the placebo group, aiming to evaluate the efficacy and safety of GPN00833 in treating inflammation and pain after cataract surgery in the Chinese population. The primary clinical endpoint of this study was the percentage of patients with zero anterior chamber cell count (i.e., no inflammation) from day 8 to day 15 after cataract surgery, while the secondary clinical endpoint was the percentage of patients with zero eye pain level (i.e., no pain) from day 4 to day 15 post-surgery.

The study results showed that in terms of anti-inflammation, the percentage of patients with zero anterior chamber cell count from day 8 to day 15 in the study drug group was significantly higher than that in the placebo group, at 31.8% and 20.0%, respectively, with statistically significant and clinically meaningful differences; in terms of analgesia, the percentage of patients with zero eye pain level from day 4 to day 15 in the study drug group was significantly higher than that in the placebo group, at 91.2% and 55.3%, respectively, also with statistically significant and clinically meaningful differences. Furthermore, the product demonstrated good safety and tolerability, and its pharmacokinetic characteristics were as expected. Overall analysis indicated that GPN00833 showed significantly better efficacy than the placebo group in treating postoperative inflammation and pain after cataract surgery, with good safety. Regarding overseas registration, the product has been approved for marketing by the U.S. Food and Drug Administration (FDA) in March 2024.

As one of China's leading comprehensive enterprises in the research, development, production, and sales of otolaryngology drugs, the group ranks among the top in the industry in terms of the number of products on the market, covering treatment areas in ophthalmology, otolaryngology, and dentistry, with a portfolio that includes chemical formulations, traditional Chinese medicine formulations, and health products, encompassing prescription drugs, OTC, medical devices, and consumer products across all channels, creating a "big otolaryngology ecosystem" that integrates "prevention + treatment + health care." In terms of innovative research and development, the group has a pipeline of multiple globally innovative products for treating "myopia," "dry eye syndrome," "pterygium," "postoperative anti-inflammatory analgesia in ophthalmology," "demodex blepharitis," and "meibomian gland dysfunction caused by demodex." In the future, this sector will adhere to the development strategy of combining Chinese and Western medicine and treating with both drugs and devices, continuously strengthening its industry influence and achieving new breakthroughs in its business areas The group has always placed a high value on the research and development of innovative products and advanced technologies, focusing on patient needs and driven by technological innovation. It has increased investment in global innovative products and advanced technologies to address unmet clinical needs, enriching and improving its product pipeline and industrial layout. By adopting a strategy of "global operational layout and dual circulation business development," it has formed a new pattern of domestic and international dual circulation development that promotes and complements each other. The group fully leverages its industrial advantages and R&D capabilities to rapidly bring technological innovation products to market, providing global patients with more advanced and diverse treatment options