The innovative drug PDP-716 Eye Drops shows positive top-line results from its U.S. pivotal Phase 3 clinical trial, which has met its primary endpoint and shown good safety profile.
Recently, Sun Pharma Advanced Research Company Ltd. (“SPARC”), the collaborative partner of China Medical System Holdings Limited (“CMS”), announced positive top-line results from its pivotal Phase III clinical trial of PDP-716 Eye Drops for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension. The trial met its pre-specified primary endpoint, demonstrating that PDP-716 Eye Drops dosed once daily is equivalent to Alphagan® P 0.1% dosed three times daily, which is also the brimonidine formulation; in terms of safety, treatment emergent adverse events of the two products were similar.
In China, the prevalence of open-angle glaucoma is approximately 2%, with most patients aged between 20 and 60 years old, and only 1 in 6 of the patients have normal intraocular pressure. The product is a novel brimonidine formulation developed by SPARC’s proprietary resin microparticle-complexed drug technology, TearActTM, which provides controlled and consistent delivery of the drug so as to improve drug bioavailability and drug exposure, enabling once daily administration. Compared with the marketed brimonidine formulations dosed three times daily, the product provides patients with greater treatment convenience .
CMS, through its wholly-owned subsidiary, acquired the product rights of PDP-716 Eye Drops in Mainland China, Hong Kong, Macao and Taiwan from SPARC in November 2019.
Further information can be found in the SPARC’s Press Release：
https://www.sparc.life/sites/default/files/2021-05/PDP-716%20topline%20results_14th%20May.pdf