China Grand Pharmaceutical and Healthcare Holdings Ltd (HKG: 0512; CGP) has announced a significant milestone in the clinical development of GPN00833, with the first patient enrolled and dosed in a Phase III study. This multi-center, randomized, double-blinded, placebo-controlled, parallel group study is designed to assess the efficacy and safety of GPN00833 in managing inflammation and pain following cataract surgery in China, with a target enrollment of 252 patients.
GPN00833: A Promising Nanosuspension Eye Drop
GPN00833 is an innovative anti-inflammatory and analgesic hormone nanosuspension eye drop. Its main active ingredient, clobetasol propionate, is a potent glucocorticoid known for its efficient local anti-inflammatory activity and strong capillary constriction. The unique nano preparation process of GPN00833 effectively addresses the challenges of low bioavailability and safety risks associated with the low water solubility of traditional hormone products.
Clinical Success and Regulatory Progress
Previous overseas Phase II and two Phase III clinical studies of GPN00833 have successfully met their clinical endpoints, demonstrating the drug’s significant efficacy and good safety profile in treating postoperative inflammation and pain in ophthalmology. Building on these positive results, a New Drug Application (NDA) for GPN00833 has been filed with the US Food and Drug Administration earlier this year, marking a crucial step towards making this innovative treatment available to patients globally.-Fineline Info & Tech
