Iveric Bio’s Zimura for Advanced Dry AMD Meets Endpoint in Second Phase 3 Clinical Trial
Eye On the Cure Research News
The company plans to seek FDA approval for the emerging therapy in first quarter of 2023
Iveric Bio has reported that its emerging treatment Zimura® has met the primary endpoint in the GATHER2 Phase 3 clinical trial for people with geographic atrophy (GA), the advanced form of dry age-related macular degeneration (AMD). Injected monthly into the vitreous, the soft gel in the middle of the eye, Zimura reduced the growth of the lesion associated with GA by 14.3 percent at 12 months of treatment. In GATHER1, the company’s previous Phase 3 clinical trial, Zimura met the primary endpoint, slowing GA lesion growth by 27.7 percent at 12 months. GATHER2 enrolled 286 participants. GATHER1 enrolled 448 participants. Both are global studies.
Iveric Bio plans to file a New Drug Application (NDA) with the US Food and Drug Administration (FDA) by the end of the first quarter of 2023.
While there are several FDA-approved therapies for wet AMD, there are currently none for the dry form of AMD.
Zimura is designed to work by inhibiting the C5 protein, which is part of the complement system. Researchers believe that the overactive complement system, part of the innate immune system, is a key culprit in the development of AMD. While the complement system plays an important role in fighting off viruses, bacteria, and other pathogens, it can be damaging when overactive.
More than 10 million people in the US and 150 million worldwide have AMD. Vision loss from dry AMD is caused by the accumulation of toxic deposits underneath the retina called drusen. The condition can cause loss of retinal pigment epithelial (RPE) cells which provide essential support for photoreceptors, the retinal cells that process light to make vision possible. The degeneration of RPE cells ultimately leads to loss of photoreceptors and central vision loss. In AMD, the macula, the central region of the retina, is affected most.
“The success of Iveric Bio’s GATHER1 and GATHER2 clinical trials is excellent news for dry AMD patients who currently have no treatment options,” says Claire Gelfman, PhD, chief scientific officer, Foundation Fighting Blindness. “We look forward to the company’s planned FDA filing. We need to get dry AMD treatments across the finish line and out to the millions who need them.”
In a post-hoc analysis of GATHER2, the company looked at the performance of Zimura in US patients only and found that the therapy reduced GA lesion growth by 25.5 percent. Iveric Bio hypothesizes that the better US outcomes may be due to US patients having entered the trial earlier in their disease course than patients in other countries.