Sun Pharma receives FDA approval for ocular pain treatment
pharmafile | April 11, 2016 | News story | Research and Development, Sales and Marketing | FDA, Sun Pharma, bromsite, ocular treatment
Sun Pharma (BSE: 524715) has announced that their ocular pain prevention treatment, BromSite (bromfenac ophthalmic solution), has been approved by the US Food and Drug Administration in patients undergoing cataract surgery.
BromSite is the first non-steroidal anti-inflammatory drug approved by the FDA to prevent pain and treat inflammation in the eye for patients undergoing cataract surgery. The solution was developed by InSite Vision, which was acquired by Sun Pharma in November 2015, and will be commercialised in the US from its Sun Ophthalmics division.
The FDA’s approval is based on positive results from Phase III studies, where a significantly higher proportion of BromSite-treated patients were pain free at Day 1 post-surgery (77% and 82%)compared to patients treated with vehicle control (48% and 62%).
This treatment is entering a potentially lucrative market segment in the US. According to IMS MAT January 2016, the US non-steroidal anti-inflammatory market grew by 8%, generated $400 million in sales and about 4 million prescriptions in the last year.
Dr Richard L Lindstrom, adjunct professor emeritus at the University of Minnesota department of ophthalmology, says: “Over the years, I’ve worked closely with the InSite team and watched them develop high quality products using the DuraSite platform. Today, I am pleased to see BromSite advance from development to market. I am confident there will be significant clinician interest in this new product. As the first NSAID labelled to prevent pain and reduce inflammation post-cataract surgery, BromSite’s approval is timely and will be welcomed by patients and clinicians alike.”
Shares of Sun Pharma were up 2% upon the announcement of the FDA approval.
Sean Murray
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