The FDA has announced that Formatech, was not in compliance with its current Good Manufacturing Practice (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 (Nexus) and a related complication called Pigmented Epithelial Detachment (PEDigree).
Lpath has initiated the process to manufacture additional drug substance and has identified an alternate fill/finish contractor.
The company plans to resume dosing in both clinical trials within four to six months subject to any necessary regulatory approvals.
Lpath president and CEO Scott Pancoast said they believe that the issue does not affect the prospects for value creation by their PEDigree and Nexus studies.