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Sun Pharma receives US FDA approval for BromSite

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First NSAID approved for prevention of ocular pain in patients undergoing cataract surgery

Sun Pharma’s wholly-owned subsidiaries has received approval from US FDA for its New Drug Application (NDA) related to BromSite (bromfenac ophthalmic solution) 0.075 per cent for the treatment of postoperative inflammation and prevention of ocular pain in patients undergoing cataract surgery. BromSite is the first non-steroidal anti-inflammatory drug (NSAID) approved by the US FDA to prevent pain and treat inflammation in the eye for patients undergoing cataract surgery. Other NSAIDs in this class are currently indicated for the treatment of inflammation and reduction of pain.

BromSite developed by InSite Vision, is the first 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 commercialise BromSite through its newly formed, US-based division, Sun Ophthalmics, in the second half of 2016. As per IMS MAT January 2016, the US NSAID Ophthalmic market grew by eight per cent, generating approximately $400 million in sales and about four million prescriptions, providing an attractive market for Sun Pharma to participate.

Sun Ophthalmics has crossed a key business milestone through BromSite’s approval. Sun Ophthalmics targets to provide eye care practitioners products that enhance their practice patterns and treatment options and to deliver those products through its unique, concierge level approach to customer care. With BromSite’s approval and additional late-stage candidates in its pipeline, Sun Ophthalmics is strongly positioned to offer a range of beneficial products and establish itself as a respected and trusted partner.

EP News BureauMumbai

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