China Grand Pharmaceutical and Healthcare Holdings Ltd (HKG: 0512; CGP) has announced the successful completion of a Phase III clinical study for its investigational drug, GPN00833, used for inflammation and pain management following cataract surgery in China, meeting all clinical endpoints.
GPN00833: A Nanosuspension Eye Drop for Inflammation and Pain
GPN00833 is an anti-inflammatory and analgesic hormone nanosuspension eye drop, with clobetasol propionate as its main active ingredient. This glucocorticoid is known for its potent local anti-inflammatory activity and strong capillary constriction effects. The unique nano preparation process of GPN00833 effectively addresses the challenges of low bioavailability and safety risks associated with the low water solubility of hormone products.
Study Results and Efficacy
The study, which evaluated the efficacy and safety of GPN00833 in managing inflammation and pain after cataract surgery, enrolled 255 patients who underwent surgery. They were randomly assigned to the GPN00833 group and the placebo group in a 2:1 ratio. The results indicated that the percentage of patients with zero anterior chamber cell count on postoperative days 8-15 in the GPN00833 group was significantly higher than the placebo group, at 31.8% versus 20.0%, respectively. For analgesic effects, the percentage of patients with zero eye pain level from the 4th to 15th day post-surgery in the GPN00833 group was significantly higher than the placebo group, at 91.2% versus 55.3%, respectively. The product demonstrated good safety, tolerability, and pharmacokinetic characteristics. The analysis concluded that GPN00833 significantly outperformed the placebo group in both anti-inflammatory and analgesic treatment for cataract surgery, with a favorable safety profile. The drug received marketing approval from the US FDA in March 2024.- Flcube.com
