BromSite™ (bromfenac) – New Drug Approval • On April 9, 2016, Sun Pharma announced that one of its wholly owned subsidiaries, InSite Vision, received FDA approval for BromSite (bromfenac) ophthalmic solution, for the treatment of postoperative inflammation and prevention of ocular pain in patients undergoing cataract surgery.

• BromSite contains bromfenac, a nonsteroidal anti-inflammatory drug (NSAID). BromSite was developed in DuraSite™, a polymer-based formulation that can be used to improve solubility, absorption, bioavailability, and residence time compared to conventional topical therapies.

— Other bromfenac products include Prolensa™, which is available as a 0.07% ophthalmic solution. Bromfenac 0.09% ophthalmic solution is generically available.

• The safety and efficacy of BromSite were based on two placebo-controlled studies in patients undergoing cataract surgery. The primary efficacy endpoint was the proportion of subjects with cleared ocular inflammation, measured by an anterior chamber cell (ACC) grade of 0 at Day 15.

— In both studies, more patients were free of inflammation with BromSite (38.1% and 57.1%) vs. placebo (22.4% and 18.8%) (p < 0.001 and p = 0.035, respectively). — In addition, more patients were pain-free at day 1 post-surgery with BromSite (76.8% and 82.1%) vs. placebo (48.2% and 62.4%) (p < 0.001).

• Similar to other bromfenac ophthalmic agents, the warnings and precautions of BromSite include slow or delayed healing, potential for cross-sensitivity, increased bleeding time of ocular tissue, keratitis and corneal reactions, and contact lens wear.

• The most common adverse events (1 – 8%) with BromSite use were anterior chamber inflammation, headache, vitreous floaters, iritis, eye pain and ocular hypertension.

• The recommended dose of BromSite is one drop to the affected eye twice daily (morning and evening) beginning 1 day prior to surgery, the day of surgery, and 14 days following surgery.

• Sun Pharma plans to launch BromSite though a newly formed U.S.-based division, Sun Ophthalmics, in the second half of 2016. BromSite will be available as a 0.075% ophthalmic solution.

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