Zimura phase 2b trial results positive in geographic atrophy secondary to dry AMD

Zimura, a complement factor C5 inhibitor, reduced geographic atrophy growth in a phase 2b clinical trial, according to a press release from Iveric bio.

The international, randomized, double-masked, sham-controlled, multicenter trial evaluated 286 patients with geographic atrophy secondary to dry age-related macular degeneration over 12 months.

Patients who received Zimura (avacincaptad pegol) 2 mg experienced a mean reduction in geographic atrophy growth of 27.38% at 12 months compared with the sham group (P = .0072). Those who received Zimura 4 mg had a mean reduction of 27.81% compared with sham (P = .0051).

“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,” Glenn P. Sblendorio, Iveric’s president and CEO, said in the release. “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.”

In addition, those in the 2 mg group had a mean change in best corrected visual acuity from baseline of –7.90 ETDRS letters compared with –9.29 letters in the sham group, whereas those in the 4 mg group had a mean change of –3.79 letters compared with –3.51 letters in the sham group.

Change in low luminance BCVA from baseline was –1.03 letters in the 2 mg group compared with –1.41 letters in the sham group and 1.53 letters in the 4 mg group compared with 2.97 letters in the sham group.

Zimura, a complement factor C5 inhibitor, reduced geographic atrophy growth in a phase 2b clinical trial, according to a press release from Iveric bio.

The international, randomized, double-masked, sham-controlled, multicenter trial evaluated 286 patients with geographic atrophy secondary to dry age-related macular degeneration over 12 months.

Patients who received Zimura (avacincaptad pegol) 2 mg experienced a mean reduction in geographic atrophy growth of 27.38% at 12 months compared with the sham group (P = .0072). Those who received Zimura 4 mg had a mean reduction of 27.81% compared with sham (P = .0051).

“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,” Glenn P. Sblendorio, Iveric’s president and CEO, said in the release. “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.”

In addition, those in the 2 mg group had a mean change in best corrected visual acuity from baseline of –7.90 ETDRS letters compared with –9.29 letters in the sham group, whereas those in the 4 mg group had a mean change of –3.79 letters compared with –3.51 letters in the sham group.

Change in low luminance BCVA from baseline was –1.03 letters in the 2 mg group compared with –1.41 letters in the sham group and 1.53 letters in the 4 mg group compared with 2.97 letters in the sham group.