PDP-716

Indication

Reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension

Product Advantage

An innovative once-a-day Brimonidine ophthalmic formulation

Innovativeness

Resin microparticle-complexed drug technology

Product Introduction

PDP-716 is a novel brimonidine formulation developed by the Group’s partner SPARC’s proprietary resin microparticle-complexed drug technology, TearActTM, which provides controlled and consistent delivery of the medicine to improve drug bioavailability and drug exposure, enabling once daily administration.

In May 2021, SPARC announced positive top-line results from the pivotal phase III clinical trial of PDP-716 Eye Drops in the U.S. 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. Compared with the marketed brimonidine formulations dosed three times daily, the product provides patients with greater treatment convenience.