Indian Sun Pharmaceuticals announced on the 14th that the US Food and Drug Administration (FDA) has approved a new drug application for its XELPROS (latanoprost eye lotion, 0.005%) for reducing open-angle glaucoma or high intraocular pressure patients The intraocular pressure, this approval makes XELPROS the first and only latanoprost formulation without benzalkonium chloride (BAK). "As the only BAT-free latanoprost, XELPROS will be an important alternative treatment option for patients with open-angle glaucoma or high intraocular pressure," said Abhay Gandhi, Sun Pharma North America CEO. BAK is a preservative commonly used in topical ocular preparations. It has been reported to cause allergic conjunctivitis, vision loss, contact dermatitis, etc. XELPROS uses the proprietary expansion gel of the Sun Pharmaceutical Advanced Research Center (SPARC). The microemulsion (SMM) technology was developed. “This technology helps drugs with limited or no solubility, eliminating the need for BAK,†said SPARC CEO Anil Raghavan. “FDA approval is an affirmation of SMM technology.†It is known that XELPROS is a translucent ophthalmic emulsion found in a randomized controlled clinical trial of open-angle glaucoma or high intraocular pressure patients with an average intraocular pressure of 23-26 mmHg, which can reduce the intraocular pressure by an average of 6- 8mmHg, the recommended dose is one drop per night, the reduction of intraocular pressure starts about 3 to 4 hours after administration, and the maximum effect is achieved in 8 to 12 hours. The most common ocular adverse reactions were eye pain/eye drop tingling and eye congestion (redness). In the patients treated with XELPROS, 55% and 41% of patients reported the above reaction, less than 1%. The patient stopped treatment because of intolerance to the adverse reaction. It is reported that Sun Pharmaceutical obtained the XELPROS license from SPARC in June 2015, and the FDA approval will trigger SPARC to obtain a milestone payment, and SPARC is also eligible for the milestone and royalties of XELPROS after commercialization in the United States. XELPROS will be produced at Sun Pharmaceuticals Halol (Gujarat, India) and will be commercialized by Sun Eye, a wholly owned subsidiary of Sun Pharmaceuticals. Porcelain Mortar & Pestle,Mortar Pestles,Medical Mortar Pestle,Porcelain Mortars Spout Yancheng Rongtai Labware Co.,Ltd , https://www.rongtailab.com