Posted from: Monday, October 08, 2018 - 12:41 PM - Present

Xelpros Approved to Reduce Elevated Intraocular Pressure

September 14, 2018 – The U.S. FDA has approved Xelpros™ (latanoprost ophthalmic emulsion) 0.005%, manufactured by Sun Pharma, to reduce elevated intraocular pressure (IOP) in patients who have open-angle glaucoma or ocular hypertension. According to the manufacturer, Xelpros is the first and only benzalkonium chloride-free (BAK-free) form of latanoprost.

Xelpros uses proprietary Swollen Micelle Microemulsion (SMM) technology from SPARCS to eliminate the need for BAK, a type preservative often used in topical drugs for ocular application. Sun Pharma in-licensed Xelpros from SPARCS in 2015. In clinical trials, the product reduced IOP by a mean of 6-8mmHg from a mean baseline of 23-26mmHg.

Recommended dosing is one drop per affected eye once every evening. As with other prostaglandins for ocular use, Xelpros may change the color of the iris, eyelid, and eyelashes. Changes to iris pigmentation are often permanent. Xelpros can also change eyelash growth and thickness.

Sun Pharma has not yet announced a launch date or pricing plans. Xelpros will be distributed in the United States by Sun Ophthalmics, the branded ophthalmic division of Sun Pharma.

Last Updated Friday, December 14, 2018 - 10:21 PM.