Sun Pharmaceutical Industries Ltd and Sun Pharma Advanced Research Company Ltd. have announced U.S. Food and Drug Administration (USFDA) approval for the New Drug Application (NDA) of XELPROSTM (latanoprost ophthalmic emulsion) 0.005% for the reduction of elevated intraocular pressure (IOP, or pressure inside the eye) in patients with open-angle glaucoma or ocular hypertension. This approval is from Sun Pharma’s Halol (Gujarat, India) facility.
Sun Pharma in-licensed XELPROSTM from SPARC in June 2015 and this approval will trigger a milestone payment to SPARC. SPARC is also eligible for milestone payments and royalties on commercialization of XELPROSTM in the US.
XELPROSTM is the first and only form of latanoprost that is not formulated with benzalkonium chloride (BAK), a preservative commonly used in topical ocular preparations. XELPROSTM is developed using SPARC’s proprietary Swollen Micelle Microemulsion (SMM) technology.
“As the only BAK-free version of latanoprost, XELPROSTM will be an important and alternative treatment option for individuals with open-angle glaucoma or ocular hypertension,” said Abhay Gandhi, CEO, North America, Sun Pharma. “This approval, coming less than one month following the approval of CEQUA™ (cyclosporine ophthalmic solution) 0.09%, reaffirms the strength of Sun Pharma’s fast-growing Ophthalmics division and its commitment to serving the needs of patients with ocular disorders.”
Anil Raghavan, CEO, SPARC said, “Approval of XELPROSTM by USFDA is a significant milestone for SPARC. It is also a validation of our SMM technology which helps to solubilize drugs that have limited or no solubility thus eliminating the need for benzalkonium chloride (BAK).”
In randomized, controlled clinical trials of patients with open-angle glaucoma or ocular hypertension with a mean baseline Intraocular pressure (IOP) of 23-26 mmHg, XELPROSTM lowered IOP by a mean of up to 6-8 mmHg.
XELPROSTM will be commercialized in the U.S. by Sun Ophthalmics, the branded ophthalmic division of Sun Pharmaceutical Industries Ltd.’s wholly owned subsidiary.
About XELPROS™
XELPROSTM (latanoprost ophthalmic emulsion) 0.005%, a translucent ophthalmic emulsion, is a topical formulation of latanoprost, a prostaglandin analogue that is used as first-line treatment for open-angle glaucoma or ocular hypertension. It is the first and only BAK-free form of latanoprost. The recommended dosage of XELPROSTM is one drop in the affected eye(s) once daily in the evening. If one dose is missed, treatment should continue with the next dose as normal. Reduction of IOP starts approximately 3 to 4 hours after administration and the maximum effect is reached after 8 to 12 hours.
Across multiple XELPROSTM clinical trials, the most frequently reported ocular adverse reactions were eye pain/stinging upon instillation and ocular hyperemia (redness), reported in 55% and 41% of patients treated with XELPROSTM, respectively. Less than 1% of patients discontinued therapy because of intolerance to these adverse events.