FDA Approves Besivance to Treat Bacterial Conjunctivitis

The U.S. Food and Drug Administration today approved Besivance (besifloxacin ophthalmic suspension 0.6 percent) for the treatment of bacterial conjunctivitis (non-viral), a contagious condition marked by irritation of the eyes and a discharge from the mucous membranes.

“Bacterial conjunctivitis is a common condition that affects people of all ages,” said Wiley A. Chambers, M.D., acting director of the Division of Anti-Infective and Ophthalmology Products in FDA’s Center for Drug Evaluation and Research. “It is important to have a variety of treatment options available to health care professionals and patients because an effective drug therapy can reduce the duration of the illness and reduce the chances of infecting others.”

Bacterial forms of conjunctivitis are common in childhood, but they can occur in people of any age. Symptoms of bacterial conjunctivitis can include red eyes, swelling, eyelids sticking together, itching, watering and a white or yellow sticky discharge from the eyes. Bacterial conjunctivitis is generally a condition that runs its course in 7-14 days.

Patients using the drug in clinical trials had a faster rate of resolution of the infection than those treated with a solution containing only a preservative. The drug was shown to be effective in treating patients age one year and older.

Adverse events were reported in less than 3 percent of patients in clinical trials. Adverse reactions included redness of the eyes, blurred vision, eye pain, irritation and itching, and headache. Besivance is an eye drop for topical use on the eyes only. It should not be injected into the eye.

Besivance is made by Bausch & Lomb, Rochester, N.Y.

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American Biotech Labs(R) Obtains FDA Approval for New Wound Care Gel Product

/PRNewswire / -- American Biotech Labs, LLC (ABL), developer of a new class of products based on the company's patented nano-catalytic SilverSol Technology(R), today announced that the company has been granted formal approval by the U.S. Food and Drug Administration (FDA) to market its ASAP Wound Dressing Gel throughout the United States. Clifton Mining Company is a major shareholder in American Biotech Labs.

The FDA 510(k) medical device approval letter confirms that ABL may market ASAP Wound Dressing Gel "for the topical management of minor cuts, lacerations, abrasions, 1st and 2nd degree burns, and skin irritations." The product utilizes ABL's innovative SilverSol Technology, which has garnered multiple patents in the U.S. and several countries throughout the world, including a broad-use patent that provides the company with exclusive rights to use its silver-based products to combat many of the world's most destructive pathogens, including malaria, tuberculosis, MRSA and HIV.

"We are delighted with the FDA's decision to grant approval for ABL to broadly market our ASAP Wound Dressing Gel," said Dr. William Moeller, a managing director of American Biotech Labs. "We feel this is a singularly effective wound care product, and it is a tremendous validation for us that ABL products have now received approval from the FDA as well as from the EPA."

ABL has performed extensive anti-microbial studies against bacteria, yeast, fungus and other pathogens. Information about these studies is available at research section of the ABL Website, www.americanbiotechlabs.com/researchprotected/researchmenu.html.

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