Miravant gets FDA list for SnET2 marketing nod

November 1, 2004

Santa Barbara, CA-Miravant Medical Technologies will launch an additional clinical trial in an effort to meet the FDA's conditions for final marketing approval of its tin ethyl etiopurpurin (SnET2).

Santa Barbara, CA-Miravant Medical Technologies will launch an additional clinical trial in an effort to meet the FDA's conditions for final marketing approval of its tin ethyl etiopurpurin (SnET2).

The FDA called for an additional confirmatory clinical trial, among other conditions, when it issued its approvable letter recently for SnET2, a light-activated drug designed to stabilize vision loss by selectively destroying the leaking vessels associated with wet age-related macular degeneration (AMD).

Phase III clinical trials of the drug showed improvement in a range of choroidal neovascularization lesions, regardless of the percent classic component or presence of occult component.

"We expect that this guidance, coupled with the knowledge we have gained about wet AMD through the phase III studies, should enable us to fulfill the requirements efficiently," he said.