Lpath stops iSONEP dosing due to cGMP issues

Lpath Inc. (OTCBB:LPTN) suspended dosing of ophthalmic product iSONEP in two trials because the company's fill/finish contractor, Formatech Inc. (Andover, Mass.), did not meet cGMP requirements. Lpath said the move is precautionary and it has received no reports of safety concerns associated with iSONEP. The company identified an alternative fill/finish contractor and plans to resume dosing in both trials within 4-6 months. The trials are the Phase Ib PEDigree trial for retinal pigment epithelium detachment (PED) and the Phase IIa Nexus trial for wet age-related macular degeneration (AMD). ...