FDA approves Bromsite (bromfenac ophthalmic solution) to treat post operative inflammation and ocular pain in cataract surgery patients- Sun Ophthalmics.
Sun Pharmaceutical Industries Ltd announced that one of its wholly owned subsidiaries has received approval from FDA 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 the first non-steroidal antiinflammatory drug (NSAID) approved by the 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 commercialize BromSite through its newly formed, US-based division, Sun Ophthalmics, in the second half of 2016.
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