Breaking News, Trials & Filings

Lpath Suspends Trials Due to Contractor Compliance Issues

FDA says Formatech was not in compliance with cGMP requirements

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Lpath, Inc. has temporarily suspended dosing of iSONEP in its PEDigree and Nexus trials. The FDA informed Lpath that its fill/finish contractor, Formatech, Inc., was not in compliance with cGMP requirements during the period that the iSONEP clinical vials were filled. Lpath has suspended dosing as a precaution to ensure the continued safety of all patients in its clinical trials. In these trials, iSONEP is being tested as a treatment for wet AMD and a related complication, Pigmented Epithelial D...

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