FDA OKs Sun Pharma’s Eye-Care Drug

Sun Pharma.Mumbai-headquartered pharmaceutical company, has received US Food and Drug Administration Approval for its new drug application (NDA) related to BromSite (bromfenac ophthalmic solution) 0.075% for the treatment of postoperative inflammation and prevention of ocular pain in patients undergoing cataract surgery.

BromSite is a non-steroidal antiinflammatory drug. It was developed by InSite Vision, using a bromfenac ophthalmic solution formulated in DuraSite, a polymer-based formulation that can be used to improve solubility, absorption, bioavailability, and residence time as compared to conventional topical therapies. Sun Pharma acquired InSite Vision in November 2015 and is likely to commercialize BromSite through its newly formed, US-based division, Sun Ophthalmics, in the second half of 2016, according to Sun Pharma.

Other pipeline candidates of Sun Ophthalmics iinclude Xelpros (latanoprost ophthalmic solution) 0.005%, being explored for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension, and DexaSite (dexamethasone) 0.1%, being explored for the treatment of blepharitis. Sun Ophthalmics is based in Princeton, New Jersey.

Source: Sun Pharma

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