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  • SPARC reports positive...

SPARC reports positive results from Phase 3 trial of ocular hypertension treatment

Ruchika SharmaWritten by Ruchika Sharma Published On 2021-05-16T10:00:09+05:30  |  Updated On 16 May 2021 10:00 AM IST
SPARC reports positive results from Phase 3 trial of ocular hypertension treatment
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Mumbai: Sun Pharma Advanced Research Company Ltd. (SPARC) has recently 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.

"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.

Read also: SPARC investigational drug shows promise in phase 3 trial for treating inflammation, pain related to ocular surgery

PDP-716 is a novel, once daily, ophthalmic suspension of Brimonidine Tartrate 0.35%. PDP-716 is developed using SPARC's proprietary TearActTM technology.
CLR_16_33 is randomized, multi-center, investigator-masked, parallel group, equivalence study of once daily PDP-716 0.35% ophthalmic suspension compared with 3 times a day Alphagan P 0.1% in subjects with open angle glaucoma or ocular hypertension.
Read also: SPARC, Tripoint ink licensing pact for Elepsia XR tablets in US




sun pharma advanced research companysparcclinical trialpdp-716open angle glaucomaocular hypertensionpdp-716 ophthalmic suspension
Ruchika Sharma
Ruchika Sharma

    Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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