The Food and Drug Administration (FDA) has granted Fast Track designation to Zimura® (avacincaptad pegol; Iveric Bio) for the treatment of geographic atrophy secondary to dry age-related macular degeneration (AMD).
Zimura is an investigational complement C5 inhibitor that is designed to decrease the activation of inflammasomes and the formation of membrane attack complex (MAC). The Company believes Zimura could treat geographic atrophy secondary to dry AMD by preventing or slowing the degeneration of retinal pigment epithelial cells.
The Fast Track designation is supported by data from an ongoing double-masked, sham-controlled phase 2b study evaluating the efficacy and safety of Zimura in 286 patients with geographic atrophy secondary to dry AMD. The 2-part study randomized patients to receive monthly intravitreal injections of Zimura 1mg, 2mg, or 4mg, or sham injections. The mean rate of change in geographic atrophy measured by fundus autofluorescence over 12 months was designated as the primary end point.
Initial topline results announced in October 2019 showed that patients treated with the 2mg and 4mg dose achieved a 27.38% (P =.0072) and 27.81% (P =.0051) reduction, respectively, in the mean rate of geographic atrophy growth over 12 months compared with the corresponding sham control group. Additionally, the analysis showed the mean rate of geographic atrophy growth with the 1mg dose over 12 months was observed to be less than with sham control.
“With no treatment options available for patients with geographic atrophy secondary to dry age-related macular degeneration the FDA’s Fast Track designation recognizes the potential of Zimura to address this unmet medical need,” stated Glenn P. Sblendorio, CEO and President of IVERIC bio. “Should the positive results from our initial Zimura pivotal clinical trial be confirmed by our second pivotal clinical trial, we believe this important designation may help expedite the registration of Zimura as a treatment option for our patients.”
In light of the recent COVID-19 pandemic, the Company has decided to delay the initiation of its second pivotal clinical trial (ISEE2008) of Zimura for geographic atrophy secondary to dry AMD. Zimura is also being investigated for the treatment of Stargardt disease.
For more information visit ivericbio.com.