Sun Pharma has announced that one of its wholly owned subsidiaries has received approval from USFDA 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 anti-inflammatory drug (NSAID) approved by the USFDA 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.
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.