Sun Pharma Advanced Research Company (SPARC) has succeeded in a phase 3 clinical trial for PDP-716 ophthalmic suspension, its investigational drug for the treatment of open angle glaucoma or ocular hypertension.
The late-stage clinical trial met its pre-specified primary endpoint by showing that daily once dosing of PDP-716 is equivalent to Alphagan P 0.1% dosed three times a day.
The primary endpoint of the phase 3 clinical trial was to assess the efficacy of once daily (QD) dosing of PDP-716 0.35% compared to three times dosing a day (TID) with Alphagan P 0.1% in patients having open-angle glaucoma or ocular hypertension.
Sun Pharma Advanced Research Company said that equivalence in intraocular pressure was shown across all the nine required timepoints, demonstrating that the two formulations of brimonidine are functionally equivalent.
The Indian biopharma company said that the safety of daily once dosing of PDP-716 compared with three times dosing of Alphagan P 0.1% was also studied.
Adverse events resulting from the treatment were identical with 38.8% in the PDP-716 arm compared to 33.2% with the Alphagan P 0.1% patient group.
Sun Pharma Advanced Research Company CEO Anil Raghavan 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 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.”
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