Squalamine enters phase 3 trial for AMD

PLYMOUTH MEETING, Pa. — An anti-angiogenic drug for the treatment of wet age-related macular degeneration has entered the first of two planned phase 3 trials, the drug’s developer said in a press release.

The two global trials of Evizon (squalamine, Genaera) will enroll subjects with predominantly classic, minimally classic and occult forms of wet AMD, the company said. Each study will be a multi-center, randomized, double-masked, controlled trial that will evaluate 40 mg and 20 mg doses of Evizon vs. placebo, dosed weekly for 4 weeks, followed by maintenance doses every 4 weeks until week 104. Genaera expects the second, identical phase 3 trial to begin later this year.

Primary end points are safety and a “significant clinical benefit” of Evizon therapy on visual acuity at 1 year. Planned secondary analyses include evaluation of changes in visual acuity from baseline in the study eye at year 2, and change in visual acuity in fellow eyes affected with wet AMD and quality of life at years 1 and 2. Photodynamic therapy with Visudyne (verteporfin for injection, QLT/Novartis) will be allowed for all subjects if deemed necessary by the study physician, the company noted.

Evizon is a “first in class” synthetic small molecule, administered systemically, that “directly interrupts and reverses multiple facets of the angiogenic process,” according to Genaera. The compound is also being evaluated in three phase 2 trials to test dosing regimens.