SOURCE: Ocular Insight, Inc.

September 17, 2008 16:47 ET

Ocular Insight, Inc. Announces Settlement of Complaint Filed July 2008, by Johnson & Johnson Vision Care, Inc.

POTOMAC, MD--(Marketwire - September 17, 2008) - Ocular Insight, Inc., a distributor of FDA cleared contact lenses, announced today that it agreed, on August 15, 2008, to an Order on Consent from a U.S. District Court in New York to discontinue certain advertising challenged in a complaint filed July 29, 2008 by Johnson & Johnson Vision Care (JJVC).

Mark Levin, President, Ocular Insight, Inc., said, "As soon as we received initial notice from JJVC, we immediately amended our marketing materials to replace 'approved by the FDA' with 'cleared by the FDA,' as contact lenses are class II medical devices 'cleared' for marketing by the FDA not 'approved.'"

"In the interest of fair competition, we feel an urgent need to comment on JJVC's recent press release regarding the settlement," said Levin. "We stand by our mission statement, 'Ocular Insight, Inc. was founded for the express purpose of introducing Substantially Equivalent Contact Lenses (as defined by the FDA) along with state-of-the-art contact lens designs and materials, allowing eye care professionals to -- at long last -- offer their patients high quality contact lenses, while supporting the professional with advantageous price points and effective profit models.'"

"Ocular Insight allows the eye care practitioner to determine if a contact lens made of the same material, same water content, same base curve, same diameter, and same method of manufacturing, is a viable substitution for a branded product they currently dispense."

"This matter was settled expeditiously," Levin added. "Ocular Insight chose not to spend significant resources fighting a large company like JJVC and challenging the FDA's use of the word 'approved' versus 'cleared' as it relates to Class II medical devices. Instead, we are determined to concentrate our resources on introducing safe and efficacious contact lenses to the ophthalmic community at price points designed to convert their low margin contact lens practice to a high margin practice."

Further information on the FDA clearance of substantially equivalent lenses can be found at http://www.fda.gov/cdrh/pdf3/K030167.pdf.

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