Sun Pharma Advanced Research Company Ltd. today reported positive top-line results from its Phase 3 trial (CLR_16_33) for its investigational drug, PDP-716 ophthalmic suspension, for the treatment of Open Angle Glaucoma or Ocular Hypertension. The trial met its pre-specified primary endpoint, demonstrating that PDP-716 dosed once daily is equivalent to Alphagan® P 0.1% dosed 3 times a day.
The primary endpoint of the trial was to evaluate the efficacy of once daily (QD) dosing of PDP-716 0.35% compared with Alphagan® P 0.1% dosed 3 times a day (TID) in subjects with open-angle glaucoma or ocular hypertension. Equivalence in intraocular pressure was demonstrated across all 9 required timepoints, showing that the 2 formulations of brimonidine are functionally equivalent.
The safety of once daily (QD) dosing of PDP-716 compared with Alphagan® P 0.1% dosed 3 times a day (TID) was also evaluated. Treatment emergent adverse events were similar with 38.8% in the PDP-716 group vs. 33.2% with Alphagan® P 0.1% group.
PDP-716 is a novel, once daily, ophthalmic suspension of Brimonidine Tartrate 0.35%. PDP-716 is developed using SPARC’s proprietary TearActTM technology.
“We are very pleased by these results for PDP-716. Once daily dosing of PDP-716 can significantly reduce the dosing frequency compared to currently marketed formulation and can have positive impact on quality of life for patients with Glaucoma. On behalf of everyone at SPARC, I would like to extend my sincere gratitude to the patients, families and investigators involved in this study.” said Anil Raghavan, CEO of SPARC.