BromSite is the first branded product launched by the company in the USA, following its focus on Specialty Business. Approved by the USFDA on April 8, 2016, BromSite (bromfenac ophthalmic solutionA 0.075% is the first NSAID approved to prevent ocular pain and treat inflammation in the eye following cataract surgery.
Developed by California-based 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 as compared to conventional topical therapies.
Commenting on the launch of BromSite, Abhay Gandhi, CEO - North America Business, Sun Pharma said, “As the first branded ophthalmic product launched by Sun Ophthalmics business division, BromSite’s launch is a significant milestone for Sun Pharma in the USA. Clinical studies have reinforced BromSite’s strong safety and efficacy profile in cataract surgery patients, culminating in this FDA indication for the prevention of ocular pain following surgery. We are confident BromSite will prove itself a quality treatment option for cataract surgeons and their patients. Furthermore, with several promising candidates in our Ophthalmics pipeline, Sun Ophthalmics is positioned to provide eye care professionals additional, quality treatment options in the near future.”
“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, an responsive commercial team. BromSite is our first opportunity to prove that commitment to eye care professionals.”
As part of its Patient Access Program (PAP), Sun Ophthalmics is committed to making BromSite available to all patients. The company will offer patient assistance wherever required.
Dr. Richard L. Lindstrom, MD, Founder and attending surgeon of Minnesota Eye Consultants and Adjunct Professor Emeritus at the University of Minnesota, Department of Ophthalmology said,“I am pleased that BromSite is now available to eye care practitioners. Multiple clinical studies have demonstrated the drug’s efficacy in preventing ocular pain and reducing inflammation in patients undergoing cataract surgery. These clinical results, in combination with BromSite’s unique label to prevent ocular pain, will make it a welcome addition to cataract surgeons' armamentarium."