Sun Pharmaceutical Industries Ltd and includes its subsidiaries or associate companies) 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. As per IMS MAT January 2016, the U.S. NSAID Ophthalmic market grew by 8%, generating approximately US$400mn in sales and about 4 million prescriptions, providing an attractive market for Sun Pharma to participate.
In two multi-center, randomized, placebo-controlled Phase-3 studies, a significantly higher proportion of BromSitetreated patients were pain-free at Day 1 post-surgery (77% and 82%) compared to patients treated with vehicle control (48% and 62%) (p<0.001). Additionally, a significantly higher proportion of subjects administered BromSite™ were inflammation-free at day 15 post-cataract surgery (57% and 38%), compared to a vehicle control group (19% and 22%) (p<0.001 and p=0.035).