Astellas company IVERIC bio has reported positive two-year-data from the Phase III GATHER2 clinical trial of IZERVAY (avacincaptad pegol intravitreal solution) to treat geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
The sham-controlled, multicentre, double-masked, randomised study evaluated the efficacy and safety of the C5 inhibitor IZERVAY.
A total of 448 patients were enrolled who received avacincaptad pegol (ACP) intravitreally or sham monthly for 12 months.
Out of these patients, 96 were re-randomised to receive ACP every month (EM), 93 were given the dosage every other month (EOM) and 203 continued to receive sham for another 12 months.
The IZERVAY monthly dosing regimen met the primary objective of reducing the GA growth rate (slope) compared to sham, at 24 months.
Similar reduction in GA growth was also observed in patients who received EOM dose of IZERVAY.
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No new safety signals were identified and overall safety of IZERVAY was consistent at 24 months of treatment compared to prior 12-month data.
The rate of choroidal neovascularisation was found to be 12% in the treatment group while it was 9% in the sham group.
No cases of occlusive or non-occlusive retinal vasculitis or ischemic neuropathy were reported.
However, one case of non-serious intraocular inflammation and culture-positive endophthalmitis were reported.
Iveric Bio senior vice-president and chief development officer Dhaval Desai said: “We are excited about these results, which show that IZERVAY continued to slow the rate of GA growth with a consistent safety profile after two years of treatment.
“We look forward to sharing results at a future scientific congress and with regulatory agencies.”