IVERIC bio has reported positive initial results from an ongoing Phase IIb clinical trial of Zimura (avacincaptad pegol) in patients suffering from dry age-related macular degeneration (AMD).
Zimura targets and inhibits complement factor C5, which is linked to the development and progression of dry AMD. The drug is believed to work by preventing or slowing down the degeneration of retinal pigment epithelial (RPE) cells.
Dry AMD is characterised by moderate and severe loss of central vision, along with the thinning of RPE cells. Geographic atrophy (GA) is the advanced stage of the disease and leads to further vision loss.
According to top-line results, the trial met its prespecified primary endpoint, where Zimura decreased the GA growth rate compared to sham control.
Over 12 months, the 2mg and 4mg doses of the drug led to a 27.38% and 27.81% statistically significant decrease in the mean GA growth rate respectively.
A preliminary descriptive analysis showed that the average percent GA growth from baseline to month 12 was less with the 1mg dose than the corresponding sham control.
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IVERIC bio noted that the results indicate a dose-response relationship across treatment arms.
Zimura was generally well tolerated, without any related inflammation and or trial discontinuations. No ocular serious adverse events and zero endophthalmitis cases were reported for the study eye.
IVERIC bio CEO and president Glenn Sblendorio said: “This is a major milestone for IVERIC bio and a potentially significant advancement for patients with GA secondary to dry AMD who currently have no treatment options.
“Based on these data, we intend to explore all options for the future development of Zimura, including the possibility for collaboration opportunities, licensing and / or potentially further internal development.”
The international, randomised, multi-centre Phase IIb trial enrolled a total of 286 patients.
In addition to GA growth rate, the trial will evaluate mean change in best-corrected visual acuity and low luminance best-corrected visual acuity.