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Sun Pharma Glaucoma Drug Approved
09/14/2018
 

FDA has approved a Sun Pharmaceutical Industries NDA for Xelpros (latanoprost ophthalmic emulsion) 0.005% for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. The company says Xelpros is the only form of latanoprost that is not formulated with benzalkonium chloride, a preservative commonly used in topical ocular preparations.

 

Approval was based on data from a randomized, controlled clinical trials of patients with open-angle glaucoma or ocular hypertension with a mean baseline intraocular pressure of 23-26 mmHg. Data showed that Xelpros lowered pressure by a mean of up to 6-8 mmHg, the company says.


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