Lantibio and TRB Chemedica have initiated phase III clinicals of their sodium hyaluronate drop. This is available OTC in Europe but they are planning on filing an NDA for it in the US.
CHAPEL HILL, N.C., US and VOUVRY, VALAIS, Switzerland, Jan. 16 /PRNewswire/ -- Lantibio, Inc. and TRB Chemedica announced today the initiation of a Phase III clinical trial with VISMED(R) in dry eye syndrome. The corresponding protocol was negotiated with the FDA under the Special Protocol Assessment (SPA) program and consists of a multi-center, randomized, controlled and double-blinded study. VISMED(R) is a patented formulation containing sodium hyaluronate, currently marketed to millions of dry eye syndrome sufferers in Europe by TRB Chemedica. VISMED(R) is being studied in the US as a treatment for dry eye syndrome, under IND 73,441 filed in June 2006. The SPA was cleared by FDA in December of 2006 and the first patients were enrolled in the study immediately thereafter. If the current Phase III study is successful Lantibio expects to file a New Drug Application (NDA) for VISMED(R) in 2008.
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