Sun Pharma Advanced Research Company Ltd. (SPARC) has reported positive top-line results from its Phase 3 trial 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 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 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.

“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 a positive impact on quality of life for patients with Glaucoma,” said Anil Raghavan, CEO, SPARC.