IVERIC bio, Inc. (NASDAQ:ISEE) today announced that the positive Phase 3 results from its GATHER1 clinical trial with Zimura® (avacincaptad pegol), a novel complement C5 inhibitor, in development for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) were published in Ophthalmology®, the Journal of the American Academy of Ophthalmology. Zimura met its pre-specified primary efficacy endpoint at 12 months and reached statistical significance in GATHER1, which was an international, multicenter, randomized, double masked, sham controlled clinical trial. The reduction in the mean rate of GA growth over 12 months was 27.38% (p-value = 0.0072) for the Zimura 2 mg group as compared to the corresponding sham control group and 27.81% (p-value = 0.0051) for the Zimura 4 mg group as compared to the corresponding sham control group. The data for both dose groups were statistically significant. Zimura was generally well tolerated in the GATHER1 clinical trial.
The published article, entitled "C5 Inhibitor Avacincaptad Pegol for Geographic Atrophy Due to Age-Related Macular Degeneration: A Randomized Pivotal Phase 2/3 Trial," is now available online at https://www.aaojournal.org/article/S0161-6420(20)30845-9/fulltext?dgcid=raven_jbs_aip_email.
"These published data bring Zimura one step closer as a potential treatment for patients with GA secondary to AMD, who currently do not have any treatment options available to them," said Glenn Jaffe, M.D., lead author and Robert Machemer Professor of Ophthalmology, Chief of the Department of Ophthalmology Retina Division, Duke University. "Because Zimura inhibits C5 which is downstream in the complement cascade, upstream homeostatic complement activities including C3 are preserved. Zimura had a favorable safety profile. A treatment effect for the Zimura 2 mg and 4 mg groups was observed as early as 6 months. GATHER1 is currently the only Phase 3 clinical trial I am aware of showing early suppression of GA growth which continued throughout the trial with continuous treatment out to 18 months."
"We are privileged to have the positive results of the Zimura GATHER1 clinical trial published in Ophthalmology, the highly-respected and peer-review publication of the American Academy of Ophthalmology," stated Kourous A. Rezaei, M.D., Chief Medical Officer of IVERIC bio. "Our second Phase 3 clinical trial, GATHER2, is currently underway to further evaluate the efficacy and safety of Zimura in patients with geographic atrophy. If the primary efficacy endpoint is met at 12 months in the GATHER 2 trial, we plan to file for registration with the US and European regulatory authorities following receipt of that data. The absence of treatment options for geographic atrophy represents an area of urgent unmet medical need and a major public health concern for the expanding aging population."
"We want to thank all the patients, clinical trial investigators and their staffs for their support and participation in this well conducted trial. We believe these robust, published, Phase 3 clinical data should further increase the enthusiasm for our ongoing GATHER2 clinical trial," stated Glenn P. Sblendorio, Chief Executive Officer and President of IVERIC bio.
In the Company's second Phase 3 clinical trial for Zimura in GA secondary to AMD, known as GATHER2, approximately 400 patients will be randomized to receive either monthly administration of Zimura 2 mg or sham during the first 12 months of the trial, at which time the primary efficacy analysis of the mean rate of change of GA growth at 12 months will be performed. At month 12, the Company plans to re-randomize patients in the Zimura 2 mg arm to receive either monthly or every other month administration of Zimura 2 mg. The final evaluation will take place at month 24.