FDA approves sun pharma Xelpros for open-angle glaucoma or hyper-eye pressure patients

open-angle glaucoma (also primary or chronic glaucoma) is the most common type of glaucoma, accounting for more than 90% of glaucoma casesThe disease is caused by blockages in the drainage tube in the eye, which causes IOP to riseThishigh eye pressure refers to IOP greater than 21mmHg, which is generally accepted in the general population of the normal upper limit of eye pressureIn individuals with hyper-eye pressure, fluid in the front of the eye cannot be discharged properly, causing increased eye pressurerecently, Indian drug
maker Sun Pharma announced that the U.SFood andDrug(
FDA(
FDA) has approved Xelpros (Ratanpropro eye emulsion, 0.005%) for open-angle glaucoma or hyper-eye pressure patients to reduce elevated intra-eye pressure (IOP)this approval, making Xelpros the first and only ratapros to be the first to be free of benzodiazepines (BAK)BAK is a preservative commonly used in local eye preparations
product( Xelpros will be (commercialized) by Sun Eye , a subsidiary of Sun Pharmaceuticals Xelpros Xelpros is a translucent eye emulsion, a local topical formulation for lattaprosin, and the first and only BAK-free lattaprosin product Lattanproprosin is a prostaglandin analogue used in the first-line treatment of open-angle glaucoma and high eye pressure 　　The recommended dose for Xelpros is one drop in the eye every night, and if you miss one dose, the next time you should continue the treatment at the normal dose IOP begins to decrease after 3-4 hours of Xelpros administration and achieves maximum results after 8-12 hours Xelpros uses the exclusive lysoluble gel micromilk (SMM) technology developed by the Sun PharmaceuticalAdvanced Research Center (SPARC) In June 2015, Sun Pharmaceuticals obtained Xelpros authorization from SPARC The approval will trigger a regulatory milestone payment from SPARC, which is also eligible for commercialization milestones and royalties for Xelpros sales in the U.S market Xelpros reduced IOP by an average of 6-8 mmHg in multiple randomized, controlled clinical studies in patients with open-angle glaucoma or hyper-eye pressure who had an average IOP of 23-26mmHg safety
the most common adverse reactions to Xelpros were eye pain/tingling and eye congestion (redness) during drips, with incidences of 55% and 41%, respectively The rate of discontinuation due to intolerance to these adverse events was less than 1%