The FDA has officially granted approval to Iveric Bio’s intravitreal avacincaptad pegol, now under the name Izervay, as a viable solution for addressing geographic atrophy secondary to age-related macular degeneration. This regulatory triumph arrives just three months subsequent to Astellas Pharma’s acquisition of the biotechnology enterprise based in New Jersey, a transaction that amounted to $5.9 billion and was successfully completed last month.
This recent endorsement of Izervay stands as a noteworthy accomplishment, marking it as the first authorized therapy for geographic atrophy (GA) that exhibits a significant reduction in the progression of GA over the course of a year. This was attested by outcomes from two Phase III studies, according to an official statement released by Astellas. Pravin Dugel, President of Iveric Bio, went on to emphasize that this ocular injection not only opens up innovative treatment avenues for medical practitioners but also offers new hope to patients throughout the United States.
The brainchild of Iveric, Izervay operates as an intravitreally administered inhibitor with a focal point on the complement C5 protein. Its influence extends beyond merely obstructing C5 cleavage; it also interjects in downstream mechanisms, specifically targeting the formation of the membrane attack complex and the inflammasome. Both of these processes are pivotal in instigating the defining symptoms of geographic atrophy.
The efficacy of Izervay’s mode of operation underwent scrutiny during the Phase III GATHER1 and GATHER2 trials. GATHER1, a Phase II/III trial of prospective, randomized, and sham-controlled nature, uncovered that at both the 2-mg and 4-mg dose levels, Izervay successfully curbed the growth of GA by 27.4% and 27.8%, respectively, over a 12-month span. This outperformed the effectiveness of the placebo treatment. These findings were further corroborated by the Phase III GATHER2 study, wherein patients who received Izervay displayed significantly subdued expansion of the GA area compared to their counterparts in the control group.
The safety record of Izervay stood out as favorable in both these trials. Within the GATHER program, instances of bleeding beneath the transparent lining of the eye emerged as the most frequently reported side effect among patients treated with Izervay, followed by heightened intraocular pressure and instances of blurred vision. The packaging and informational labeling of Izervay reflect these safety considerations, encompassing cautions against potential complications like retinal detachment, elevated intraocular pressure, neovascular age-related macular degeneration, and eye infections. It’s worth noting the absence of a boxed warning associated with Izervay.
The anticipation shared by both Astellas and Iveric foresees Izervay becoming accessible within a span of two to four weeks, marking its arrival on U.S. shelves approximately six months after the FDA granted approval to its counterpart, Apellis’ Syfovre (pegcetacoplan). Both of these treatments, administered intravitreally, operate on a shared premise of disrupting the cascade of complement activation to impede the progression of lesions. However, it’s pertinent to underscore that as of now, neither of these treatments has provided substantial evidence of conferring significant advantages pertaining to visual functionality.