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Sep 03, 2012
 |  BC Week In Review  |  Clinical News  |  Clinical Status

Sphingomab: Phase IIa resumed

FDA lifted a clinical hold on iSONEP from Lpath, which will resume dosing of the ophthalmic product in the double-blind, U.S. Phase IIa Nexus trial to treat wet AMD. In January, FDA placed the hold on Nexus and the Phase Ib PEDigree trial because the company's fill/finish contractor, Formatech Inc. (Andover, Mass.), did not meet cGMP requirements. Lpath subsequently used a different fill/finish contractor to manufacture new product (see BioCentury, Jan. 30).

Lpath said Nexus will also now evaluate iSONEP for pigmented epithelium detachment (PED) secondary to wet AMD, which was the indication...

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