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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 Detachment.

Lpath has initiated the process to manufacture additional drug substance and has identified an alternate fill/finish contractor. Lpath plans to resume dosing in both clinical trials within four to six months subject to any necessary regulatory approvals.

Scott Pancoast, Lpath’s president and chief executive officer, said, “While we are disappointed to learn about these FDA concerns, we believe this issue does not affect the prospects for value creation by our PEDigree and Nexus studies.”

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