Lpath suspends dosing after FDA warns of CMO failings
Lpath has suspending dosing in its iSONEP clinical trials after learning the CMO handling fill and finish has cGMP failings.
The US Food and Drug Administration (FDA) told Lpath that its contract manufacturing organisation (CMO), Formatech, was not in compliance with regulations when the vials of iSONEP were filled.
Lpath has found an alternative fill and finish contractor and begun work on manufacturing new drug substance. In the meantime though Lpath has suspended dosing of iSONEP in clinical trials looking at its effect on wet AMD and pigmented epithelial detachment.
Scott Pancoast, CEO of Lpath, 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.”
Shares in Lpath closed down 23 per cent after the news.
