If I'm not mistaken... this is the same VisMed product that has been sold OTC in Europe for awhile and it's headed for the US Rx market in... probably not too long. I would think it can't be too hard to get this approved.
Full news report on Money.com
CHAPEL HILL, N.C., and VALAIS, Switzerland, Nov. 5 /PRNewswire/ -- Lantibio, Inc. and TRB Chemedica announced today the signing of a licensing agreement with a subsidiary of Alcon, Inc. for the US development, marketing, and manufacture of a Dry Eye Syndrome product. The product consists of a TRB patented formulation containing sodium hyaluronate and is currently being studied in the US under an IND by a subsidiary of Lantibio. An ongoing multi-center Phase III pivotal study is being conducted under the FDA's Special Protocol Assessment program. Lantibio expects to file an NDA in 2008 for the product as a treatment for Dry Eye Syndrome.
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