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Sun Pharmaceutical Industries Ltd has announced the launch of BromSite (bromfenac ophthalmic solution) 0.075% in the US market. The nonsteroidal antiinflammatory drug is indicated for the treatment of postoperative inflammation and prevention of ocular pain in patients undergoing cataract surgery. The agent will be marketed by Sun Ophthalmics, the company’s branded ophthalmic business division, according to a news release. BromSite is the first branded product launched by the company in the United States.
BromSite was approved by the FDA in April, and it is the first nonsteroidal antiinflammatory agent approved to prevent ocular pain and treat inflammation after cataract surgery. Developed by California’s InSite Vision, a subsidiary of Sun Pharma, it is also the first bromfenac ophthalmic solution formulated in DuraSite, a polymer-based drug delivery system that is used to improve drug solubility, absorption, bioavailability, and residence time compared with conventional topical therapies.
“This is an exciting, important moment for Sun Ophthalmics,” said Jerry St. Peter, vice president & head, Sun Ophthalmics. “The BromSite launch marks not only the unveiling of our first brand, but the entry of a new, robust sales force and marketing team dedicated to optimal customer service. We are committed to providing products that enhance doctors’ practice patterns and treatment options, as well as delivering these products through a talented, knowledgeable, and responsive commercial team. BromSite is our first opportunity to prove that commitment to eye care professionals.”
The company’s drug candidate Xelpros (latanoprost 0.005%) is a prostaglandin formulated with a lipid-based, swollen micelle microemulsion to solubilize the drug, thus eliminating the need for benzalkonium chloride. FDA approval is anticipated in 2017, the company noted.
Earlier this year, Sun Pharma announced that it is acquiring Ocular Technologies, a portfolio company of Auven Therapeutics. Sun Pharma will now own exclusive, worldwide rights to Seciera (cyclosporine ophthalmic emulsion) 0.09%. The agent is currently in phase 3 clinical trials for the treatment of dry eye disease. Seciera’s novel formulation is a clear, preservative-free, aqueous solution. In a completed phase 2b/phase 3 clinical trial in 455 patients, Seciera reportedly demonstrated a rapid onset of action and was well tolerated by the study population.
Seciera is now being studied in a multicenter, randomized, double-blind, placebo- controlled, two-arm, phase 3 confirmatory trial at 47 investigational sites in the United States. The trial is designed to confirm the significant, clinically meaningful increase in the signs of dry eye disease exhibited in the previous phase 2b/3 study. Enrollment has been completed with 747 patients, the company stated, and top-line results are anticipated in the first quarter of 2017. Assuming the confirmatory study is successful, the regulatory submission for Seciera will follow thereafter.
Sun Pharma will pay $40 million upfront to Auven, plus development and sales milestones and tiered royalty on sales of Seciera. n