The U.S. Food and Drug Administration (FDA) will review a New Drug Application (NDA) for bepotastine ophthalmic solution on June 26 during its Dermatologic and Ophthalmic Drugs Advisory Committee meeting, drug developer Ista (Irvine, Calif.) said. Ista filed the NDA for Bepreve (bepotastine) as a treatment for ocular itching associated with allergic conjunctivitis in November 2008. The compound is a non-sedating, highly selective antagonist of the histamine (H1) receptor. It has a stabilizing effect on mast cells and it suppresses the migration of eosinophils into inflamed tissues, according to Ista. The compound’s primary mechanisms of action are believed to make it an effective treatment for ocular itching associated with allergic conjunctivitis. Bepotastine was approved in Japan for use as a systemic drug in the treatment of allergic rhinitis and urticaria/pruritus in July 2000 and January 2002, respectively, and is marketed by Mitsubishi Tanabe Pharma Corporation (formerly Tanabe Seiyaku Co., Ltd.) under the brand name Talion. In 2001, Tanabe Seiyaku granted Senju Pharmaceutical Co., Ltd., exclusive worldwide rights, with the exception of certain Asian countries, to develop, manufacture and market bepotastine for ophthalmic use. In 2006, ISTA licensed the exclusive North American rights from Senju to an eye drop formulation of bepotastine for the treatment of allergic conjunctivitis.

The U.S. FDA has approved Besivance (besifloxacin ophthalmic suspension 0.6%, Bausch & Lomb, Rochester, N.Y.) for the treatment of bacterial conjunctivitis, the agency said. 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 1 year and older, the FDA said. Adverse events were reported in less than 3% of patients in clinical trials. Adverse reactions included redness of the eyes, blurred vision, eye pain, irritation and itching, and headache.

Paradigm Medical Industries, Inc. (Salt Lake City, Utah) said it will begin the process to upgrade its CPT code (0189T) for its Blood Flow Analyzer (BFA) from the American Medical Association from an investigational level (Class III) to one that will be reimbursed. The Blood Flow Analyzer is used to detect glaucoma and aid in managing the disease.

Many allergy sufferers say symptoms such as itchy, dry, red and watery eyes leave them frustrated and irritable, tired, and distracted, according to a new survey of 800 people conducted by the Asthma & Allergy Foundation of America (AAFA). About 40% of women allergy sufferers surveyed say their red and puffy eyes make them look tired and unattractive. Among those who wear contact lenses, other problems arise. When their allergies act up, half (50%) say they switch to glasses, while 45% report that they wear their contacts less often.  For some, not being able to wear their contacts affects how they feel about themselves and impacts their performance at work, school, and when playing sports. “Having to stop wearing their contacts or wear them less frequently creates a wide range of emotions among allergy sufferers,” says Mike Tringale, director of external affairs, AAFA. “Contact lens wearers say they feel less attractive when wearing their glasses (37%), unhappy (35%), less confident without their contacts (29%), and less able to perform activities as well as when they are wearing their contact lenses (26%).”
Other major findings from the survey—supported financially by Johnson & Johnson’s 1-Day Acuvue Moist contact lenses—show:

• Spring was identified by 67% of respondents as the most troublesome time of year for eye-related allergies. Over half (51%) say they experience eye allergy symptoms all year long. One-quarter of all respondents (26%) report fall as the worst time for eye allergies.
• Half of women surveyed (52%) report that their eyes are so itchy as a result of their allergies that it causes them to rub their eyes and rub off makeup.
• About four in ten (39%) of allergy sufferers say they have consulted with an allergy specialist about their eye-related allergy symptoms. They also report consulting with their family practitioner (28%), optometrist (28%), or ophthalmologist (28%).

To help allergy sufferers better understand and manage the condition, AAFA offers a free educational brochure titled Eye Health & Allergies.

Bausch & Lomb (B&L; Rochester, N.Y.) has settled nearly 600 fungal-infection lawsuits related to its ReNu with MoistureLoc multipurpose contact lens solution for more than $250 million, according to an AP news item. There were more than 700 contact lens wearers in the U.S. and Asia who said they were exposed to Fusarium keratitis as a result of using the solution. Seven people in Florida, Maryland, New York, Oregon, Tennessee and West Virginia had to have an eye removed. At least 60 more Americans needed corneal transplants, according to the AP. The U.S. Centers for Disease Control and Prevention confirmed 180 cases in 35 states from June 2005 through September 2006, and continued to hear of sporadic, unconfirmed cases in the months after MoistureLoc was withdrawn, AP said. While B&L says it has settled “the vast majority of fungal infection cases,” it is challenging another 500-plus lawsuits linking MoistureLoc to assorted bacterial, viral and parasitic afflictions. Last week, a pretrial hearing in New York was to decide if there existed a reliable scientific basis for arguing the link, AP reported.

EYEWORLD WEEK Online edited by David Laber and Enette Ngoei

EyeWorld Week Online (ISSN 1089-0319), a digital publication of the American Society of Cataract and Refractive Surgery and the American Society of Ophthalmic Administrators, is published every Monday, distributed by e-mail, and posted live on Monday mornings.

Chief Medical Editors: Stephen A. Obstbaum, M.D., and Stephen S. Lane, M.D.

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