Iveric stock soars 41% as eye disorder drug Zimura meets main goal in phase 3 trial

gorodenkoff

Iveric bio (NASDAQ:ISEE) said its medicine Zimura met the main goal of a second phase 3 trial called GATHER2 to treat an eye disease called geographic atrophy (GA).

GA is a progressive degeneration of the macula, as part of late-stage age-related macular degeneration (AMD), a disorder which can lead to vision loss.

The main goal of the study, which evaluated Zimura in 225 people versus a sham in 222 people, was the mean rate of growth (slope) in GA area at one year.

Zimura (avacincaptad pegol) met the main goal with 14.3% Reduction in mean rate of growth (slope) in GA area over one year using square root transformation; 17.7% reduction using observed GA area, the company said in a Sept. 6 press release.

"We are thrilled to see for the first time an investigational therapy with a statistically significant reduction in the rate of GA progression at the 12-month primary endpoint across two Phase 3 clinical trials," said Iveric CEO Glenn Sblendorio.

For best corrected visual acuity (BCVA), a favorable trend for Zimura 2 mg was seen consistent with GATHER1. However, for low luminance best corrected visual acuity ((LL BCVA)) a favorable trend was not seen, according to Iveric.

The company added that the incidence of choroidal neovascularization ((CNV - abnormal growth of new blood vessels beneath the eye which can cause AMD) in the study eye was 15 patients in the Zimura 2 mg group and 9 patients in the sham group.

Iveric noted that no events of endophthalmitis (inflammation of intraocular fluids) no intraocular inflammation events, and no ischemic optic neuropathy (damage of optic nerve in eye) events through the year. The most frequently reported ocular adverse events were due to the injection procedure.

Iveric said it plans to submit a new drug application to the FDA by the end of Q1 2023.

ISEE +41.42% to $13.35 premarket Sept. 6