BRIEF—Positive Ph IIb data for Iveric bio's Zimura

Shares of USA-based Iveric bio, previously known as Ophthotech Corp, leapt almost 80% to $1.67 in early trading today, after it announced initial top-line data confirming that Zimura (avacincaptad pegol), the company’s complement factor C5 inhibitor, met its prespecified primary endpoint in reducing the rate of geographic atrophy (GA) growth in patients with dry age-related macular degeneration (AMD) in a randomized, controlled Phase IIb clinical trial.

The reduction in the mean rate of GA growth over 12 months was 27.38% (p-value = 0.0072) for the Zimura 2mg group as compared to the corresponding sham control group and 27.81% (p-value = 0.0051) for the Zimura 4mg group as compared to the corresponding sham control group.

“This is a major milestone for Iveric bio and a potentially significant advancement for patients with GA secondary to dry AMD who currently have no treatment options,” stated Glenn Sblendorio, chief executive and president.

Will explore partnering opportunities

“Based on these data, we intend to explore all options for the future development of Zimura, including the possibility for collaboration opportunities, licensing and/or potentially further internal development,” he added.

These data for both dose groups were statistically significant. Although efficacy data from patients receiving Zimura 1mg was not part of the prespecified statistical analysis, preliminary descriptive analysis indicated that, on average, the percent GA growth from baseline to month 12 for Zimura 1mg group was less than for the corresponding sham control group. The overall data suggest a dose response relationship across treatment groups.