ABVC - ABVC gains after submitting Vitargus phase 2 study plan to Australian ethics committee
ABVC Biopharma (NASDAQ:ABVC) on Thursday said it had submitted its phase 2 study plan for its vitreous substitute Vitargus to an Australian regulatory ethics committee. ABVC said that if the mid-stage study gets the approval of the Australian Bellberry Human Research Ethics Committee, it will lead to a clinical trial submission to the drug regulator TGA, which is the final regulatory step before study initiation. ABVC's Vitargus can be used by eye surgeons and doctors as a substitute for the vitreous humor, which is a clear gel-like substance that lies behind the iris of the eye. Removal of the vitreous humor will allow the surgeon or doctor to gain access to the back of the eye and the retina. The mid-stage study is targeted to begin in Aug. 2022 in both Australia and Thailand and is expected to be completed by the end of 2023, said ABVC CEO Howard Doong. ABVC
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ABVC gains after submitting Vitargus phase 2 study plan to Australian ethics committee