SPARC achieves successful results in phase 3 clinical trial of PDP-716, an investigational drug

Sun Pharma Advanced Research Company Ltd (SPARC), a global pharmaceutical company announced on Friday that it has achieved success in phase 3 trial of its investigational drug namely, PDP-716 ophthalmic suspension.   

This novel drug is an ophthalmic suspension of Brimonidine Tartrate 0.35 per cent and is used for the treatment of open-angle glaucoma or ocular hypertension.   

The trial fulfilled the pre-requisite primary endpoint and the results demonstrated that PDP-716 taken once daily is equivalent to Alphagan P 0.1 per cent, taken thrice a day.  

The main aim of the trial was to assess the efficacy of once-daily dosing of PDP-716 0.35 per cent compared with Alphagan P 0.1 per cent dosed 3 times a day in subjects with open-angle glaucoma or ocular hypertension. The trial exhibited equivalence in intraocular pressure across all nine required time points, demonstrating that the two formulations of Brimonidine are functionally equivalent.  

The assessment of the safety aspect of once-daily dosing of PDP-716 compared with Alphagan P 0.1 per cent dosed 3 times a day was also done. It was found that the adverse events emerging out of the treatment were similar with 38.8 per cent in the PDP-716 group as against 33.2 per cent with Alphagan P 0.1 per cent group.  

At the time of market closing on Friday, the share price of Sun Pharma Advanced Research Company Ltd was trading at Rs 219.75, a fall of 8.27 per cent over Wednesday’s closing price of Rs 239.55 on BSE.