SPARC Reports Positive Results from Phase 3 Clinical Trial of PDP-716 for Treatment of Open Angle Glaucoma

Sun Pharma Advanced Research Company Ltd. (SPARC) on Friday, May 14, 2021, reported positive top-line results from its Phase 3 trials (CLR_16_33) for its investigational drug, PDP-716 ophthalmic suspension. The drug is used for the treatment of Open Angle Glaucoma or Ocular Hypertension.

The company in a regulatory filing at BSE said, the trial met its pre-specified primary endpoint, demonstrating that PDP-716 dosed once daily is equivalent to Alphagan P 0.1 per cent 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 per cent compared with Alphagan P 0.1 per cent 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 time points, 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 per cent dosed 3 times a day (TID) was also evaluated. Treatment-emergent adverse events were similar with 38.8 per cent in the PDP-716 group vs. 33.2 per cent with Alphagan® P 0.1 per cent group.

Anil Raghavan, CEO of SPARC, said, "We are very pleased by these results for PDP-716. Once daily dosing of PDP-716 can significantly reduce the dosing frequency compared to the currently marketed formulation and can have a positive impact on the 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."

About PDP-716: PDP-716 is a novel, once daily, ophthalmic suspension of Brimonidine Tartrate 0.35 per cent. PDP-716 is developed using SPARC's proprietary TearActTM technology.

About CLR_16_33: CLR_16_33 is randomized, multi-center, investigator-masked, parallel group, equivalence study of once daily PDP-716 0.35 per cent ophthalmic suspension compared with 3 times a day Alphagan® P 0.1 per cent in subjects with open angle glaucoma or ocular hypertension.