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SPARC reports positive results from Phase 3 trial for its investigational ophthalmic suspension


Sun Pharma Advanced Research Company today 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.
PDP-716 is a novel, once daily, ophthalmic suspension of Brimonidine Tartrate 0.35%. PDP-716 is developed using SPARC s proprietary TearActTM technology.
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Alembic Pharma gets USFDA nod for generic ophthalmic drug


The drug maker received a final approval from the US drug regulator for its Abbreviated New Drug Application (ANDA) for dorzolamide hydrochloride and timolol maleate ophthalmic solution.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Cosopt Ophthalmic Solution, 2% and 0.5% of Akorn Operating Company.
Dorzolamide hydrochloride and timolol maleate ophthalmic solution is a combination of dorzolamide hydrochloride carbonic anhydrase inhibitor, and timolol maleate, a beta-adrenergic receptor blocking agent, indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers.
As per IQVIA, dorzolamide hydrochloride and tirnolol maleate ophthalmic solution USP, 2% and 0.5% has an estimated market size of $80 million for twelve months ending December 2020. ....

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Study finds that not all patients with elevated eye pressure need treatment to prevent vision loss


Study finds that not all patients with elevated eye pressure need treatment to prevent vision loss
More than 20 years after the launch of a landmark clinical trial, follow-up examinations and analyses found that not all patients with elevated eye pressure need pressure-lowering treatment to prevent vision loss from glaucoma.
When the study was launched, it was universally accepted that all patients with elevated eye pressure should be given medication to lower that pressure. The Ocular Hypertension Treatment Study -; funded by the National Eye Institute of the National Institutes of Health (NIH) and led by researchers at Washington University School of Medicine in St. Louis -; recruited more than 1,600 patients nationally who were at moderate to high risk for glaucoma because of elevated eye pressure. The purpose was to evaluate how successful medication was at preserving vision. ....

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