Iveric bio announced the design of a second pivotal trial for Zimura, a complement C5 inhibitor in development for the treatment of geographic atrophy.
Following the positive results of a phase 2b trial, the company plans to randomly assign 400 patients to receive monthly doses of either Zimura (avacincaptad pegol) 2 mg or a controlled sham, according to a press release.
“In the first trial, both the Zimura 2 mg and Zimura 4 mg doses met the primary efficacy endpoint at month 12 with statistical significance and similar efficacy as compared to sham. Since Zimura 2 mg is administered as a single intravitreal injection, as compared to two intravitreal injections for Zimura 4 mg, the upcoming trial will compare the safety and efficacy of the Zimura 2 mg dose to sham control in patients with GA,” Kourous A. Rezaei, MD, Iveric chief medical officer, said in the release.
Consistent with the previous trial design, doses will be administered over a 12-month period in which geographic atrophy growth will be measured by fundus autofluorescence at three separate time points. After the initial 12 months of the trial, patients in the Zimura 2 mg group will again be randomized to receive doses either monthly or every other month. The final evaluation will take place at the end of 24 months.