India-based drug major Sun Pharmaceuticals has received an approval from the U.S. Food and Drug Administration (USFDA) for its anti-inflammatory eye drug, BromSite. Sun Pharma, which is the world's fifth largest pharma company, is looking for a substantial share in the non-steroidal inflammatory drug (NSAID) market in the U.S, that grew by 8 percent, generating sales worth $ 400million and nearly 4 million prescriptions in 2015, as per IMS MAT January, 2016.
Sun Pharma informed the Bombay Stock Exchange (BSE) in a filing that the company has crossed a key business milestone with the USFDA approval of BromSite.
It further said Sun Ophthalmics, the newly formed U.S. division of the company, would target both eye care practitioners as well as patients for its drug. Sun Ophthalmics is strongly positioned to offer a range of beneficial products and establish itself as a respected and trusted partner, the filing said.
Bromsite 0.075 percent solution is used for the treatment of postoperative inflammation and prevention of ocular pain in patients undergoing cataract surgery. The drug company said BromSite has been developed by one of its wholly owned subsidiaries, InSite Vision, which it acquired in Nov, 2015. It further said the drug is likely to enter the U.S. markets in the second half of 2016.
"Over the years, I have worked closely with the InSite team and watched them develop multiple high quality products using the DuraSite platform. I am pleased to see BromSite advancing from development stage to marketing. I am confident there would will be significant clinician interest in this new product," Richard L. Lindstrom, founder and attending surgeon of Minnesota Eye Consultants, and Adjunct Professor Emeritus at the University of Minnesota Department of Ophthalmology, said.
He added that as the first NSAID labeled to prevent pain and reduce inflammation post-cataract surgery, BromSite's approval is timely and will be welcomed by patients and clinicians alike.
Sun Pharma said in its phase 3 clinical studies, 77-82 percent of patients treated with BromSite were pain-free on the first day post the cataract surgery while 38-57 percent patients were inflammation-free 15 days after the surgery.
Meanwhile, the Sun Pharma stock was trading at Rs. 815.3 at 11.23 a.m Monday on BSE, up by 0.43 percent from its previous close at Rs. 811.8.