China Grand Pharmaceutical and Healthcare Holdings Ltd (HKG: 0512; CGP) has announced that it has received marketing approval from the US Food and Drug Administration (FDA) for its hormone nanosuspension eye drops GPN00833 (APP13007), designed for anti-inflammatory and analgesic effects following ophthalmic surgery. Additionally, the company has gained clinical trial approval from China’s National Medical Products Administration (NMPA) for its novel ophthalmic drug GPN00884, aimed at arresting childhood myopia.
GPN00833, an anti-inflammatory and analgesic hormone nanosuspension eye drop, has clobetasol propionate as its primary active ingredient. This potent glucocorticoid is known for its efficient local anti-inflammatory activity and strong capillary constriction. The unique nanoformulation process of GPN00833 addresses the low bioavailability and safety risks associated with the low water solubility of hormone products. The drug has successfully met the main primary endpoint in an overseas Phase II study and two Phase III clinical studies, demonstrating significant efficacy and good safety in treating postoperative ophthalmic conditions. It is currently undergoing a Phase III clinical study in China.
GPN00884, in contrast to low concentration atropine eye drops, does not cause pupil dilation and is devoid of adverse reactions such as photophobia or decreased accommodation. The drug’s administration period is not restricted, which can enhance patient compliance. Given the current lack of drugs with proven efficacy and safety in delaying the progression of myopia in children in China, GPN00884 is anticipated to offer a new clinical treatment option for doctors and patients.- Flcube.com
