Eyeworld

EW CATARACT 41 AMOILS Minimize total procedure time Avoid alcohol damage to surrounding tissue No need for subsequent scraping Uniform epithelium removal in only 5 - 7 seconds Improved clinical outcomes of CXL and PRK with T. 800.461.1200 www.innovativexcimer.com e time scra r ping mes m terms of delivery vehicle technology. This advance truly addresses another unmet need in the marketplace." The FDA first approved brom- fenac for use in the U.S. in 2005. BromSite, developed by InSite Vision (Alameda, California), is the first bromfenac ophthalmic solution formulated in DuraSite, a bioadhe- sive synthetic cationic polymer that improves drug solubility, absorption, bioavailability, and residence time as compared to conventional drops. Sun Pharma acquired InSite Vision in November 2015 and is likely to commercially launch BromSite by the end of 2016. The DuraSite drug delivery platform is currently used in AzaSite (azithromycin 1%, Akorn, Lake Forest, Illinois) and Besivance (besifloxacin 0.6%, Bausch + Lomb, Bridgewater, New Jersey) for the treatment of bacterial conjunctivitis. In two multicenter, random- ized controlled trials, 77% and 82% of BromSite-treated patients were pain-free at day 1 postop compared to 48% and 62% of patients treated with the control. In addition, 57% and 38% of patients given BromSite were inflammation-free at day 15 postop compared to 19% and 22% of patients in the control group, according to a press release from Sun Pharma. "Over the years, I've worked closely with the InSite team and watched them develop multiple high quality products using the DuraSite platform," said Richard Lindstrom, MD, founder and attending surgeon, Minnesota Eye Consultants, and adjunct professor emeritus, University of Minnesota, Bloomington, in a press release from Sun Pharma. "Today, I am pleased to see BromSite advance from devel- opment to market. I am confident there will be significant clinician interest in this new product." How it works DuraSite is a non-toxic, biocompati- ble synthetic polymer of polyacrylic acid that stabilizes small molecules in an aqueous matrix. The matrix sits on top of the ocular surface and the suspended drug diffuses from the polymer into the tear film, where it washes over the cornea and conjunctiva. The unused portion of the poly- mer and drug solution are removed through the normal tear drainage system. Because of its high molec- ular weight, the DuraSite polymer does not penetrate the eye or other mucous membranes and passes safe- ly out of the eye without changing chemically. The DuraSite drug delivery system can maintain therapeutic doses of a drug on the ocular surface for up to 6 hours, as opposed to 1 to 2 hours with conventional drops. Many drugs formulated in DuraSite can be administered once daily, as opposed to several times daily with conventional drops. The first drug formulation to use the DuraSite platform was a saline solution called AqueSite and was used to treat dry eye in the early 2000s. "This was a first attempt to produce a longer lasting tear on the surface of the eye," Dr. Sheppard said. Several years later, DuraSite was used for a new formulation of pilocarpine, but the drug was never widely adopted, according to Dr. Sheppard. "The idea of changing pilocarpine from a four-times-a-day drug to a one-time-a-day drug was revolutionary," he said. However, the somewhat obscure pilocarpine formulation did not catch on among eye surgeons or glaucoma specialists. The next drug to use DuraSite, AzaSite, was not introduced until more than 10 years later, and soon after, a second antibiotic was intro- duced—Besivance. Besifloxacin has never been used in animals or systemically in humans, and its molecular structure has a remarkably favorable sensi- tivity pattern, Dr. Sheppard said, particularly for multi-drug resistant staphylococci. That, coupled with the DuraSite platform, has made it popular among surgeons, he said, and it is useful off label, even for potentially blinding infections such as bacterial keratitis. InSite Vision is also currently de- veloping DexaSite, a formulation of 0.1% dexamethasone in DuraSite for the treatment of non-bacterial bleph- aritis and ocular inflammation. EW Editors' note: Dr. Sheppard has finan- cial interests with Bausch + Lomb and Sun Pharma. Contact information Sheppard: docshep@hotmail.com

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