Iveric bio provided further clinical details and its development strategy for Zimura (avacincaptad pegol), a novel complement C5 inhibitor, for the treatment of geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD). Based on the study design and the robustness of the recently announced topline data from a randomized, double masked, sham controlled Zimura clinical trial, the company believes that only one additional pivotal, randomized, double masked, sham controlled clinical trial would potentially be needed to demonstrate the safety and efficacy of Zimura in GA secondary to dry AMD in a manner sufficient to support regulatory approval, assuming that Zimura’s safety and efficacy profile remains consistent with the findings observed to date and subject to regulatory review, according to a company news release.
The company also announced that it has begun to identify U.S. and international clinical trial sites for the second pivotal clinical trial in GA secondary to dry AMD and plans to start enrolling patients in the first quarter of 2020.
On October 28, 2019, the company announced that Zimura met its prespecified primary efficacy endpoint and reached statistical significance in a randomized, double masked, sham controlled clinical trial in GA secondary to dry AMD. Zimura was generally well tolerated after 12 months of administration. Iveric bio provided further details supporting the positive results from the clinical trial in the company’s Quarterly Report on Form 10-Q filed on November 12, 2019.
“This is an exciting milestone for Iveric bio as we are moving Zimura forward for GA secondary to dry AMD expeditiously,” Glenn P. Sblendorio, Chief Executive Officer and President of Iveric bio, said in the news release. “We are extremely pleased with the totality of the Zimura data to date and the potential for providing a treatment option to patients and their physicians, where there is an urgent unmet medical need. We are initiating the second pivotal clinical trial with the goal of enrolling our first patient in the first quarter of 2020. We plan to continue to explore all options for the future development and potential commercialization of Zimura, including potential collaboration and out-licensing opportunities, while we commence phase 3 activities.”
“AMD is a leading cause of vision loss in people over the age of 50, typically affecting both eyes. Dry AMD is reported to account for 85% to 90% of all AMD cases. Although we have various anti-VEGF treatment options available for wet AMD, which represents approximately 10% to 15% of AMD cases, we currently have no FDA or European Medicines Agency approved treatment options available for patients with dry AMD or GA, which is the advanced stage of dry AMD,” Kourous A. Rezaei, MD, Chief Medical Officer of Iveric bio, said in the news release. “The Zimura clinical data to date in GA secondary to dry AMD are very encouraging and we will seek to leverage our efficient execution and deep expertise in retinal drug development with the goal of bringing Zimura to patients as soon as feasibly possible.”