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Business EconomyPosted at: Sep 14 2018 2:33PM


Sun Pharmaceuticals Industries receives USFDA approval for XELPROS

Mumbai, Sept 14(UNI)Sun Pharmaceutical Industries Ltd. and Sun
Pharma Advanced Research Company Ltd today said that company has
received U.S. Food and Drug Administration approval for New Drug
Application (NDA) of XELPROS 0.005 pc 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 facility in Gujarat, India.
Sun Pharma in-licensed XELPROS 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 XELPROS in the US, Sun pharma release said
XELPROS is the first and only form of latanoprost that is not
formulated with benzalkonium chloride (BAK), a preservative commonly
used in topical ocular preparations. XELPROS 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,''
said Anil Raghavan, CEO, SPARC.
Xelpros will be commercialised in the US by Sun Ophthalmics, the
branded ophthalmic division of Sun Pharma.
In the US, glaucoma is a leading cause of irreversible blindness,
second only to macular degeneration. More than 2.25 million
Americans older than 40 years have open-angle glaucoma.
Worldwide, glaucoma is the second leading cause of blindness,
surpassed only by cataracts; more than 2 million people around the
world will develop open-angle glaucoma each year, and more than 3
million are bilaterally blind that is in both eyes from open-angle
glaucoma.
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