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New injections for late-stage AMD

Phase III trial shows efficacy for reducing GA area growth rate

Cheryl Guttman Krader

Posted: Thursday, December 3, 2020


Frank G Holz MD

Intravitreal avacincaptad pegol (Zimura, IVERIC bio) has shown signs of efficacy for the treatment of geographic atrophy (GA) due to age-related macular degeneration (AMD) in a Phase III clinical trial, reported Frank G Holz MD, at the 2020 EURETINA Virtual meeting.

“Zimura targets complement 5 in the complement pathway. Groups treated with either the 2mg or 4mg dose of Zimura in GATHER1 showed a statistically significant reduction in GA growth rate over 12 months of approximately 27% compared with sham-treated controls.

The reduction in lesion growth was already present at six months in both dose groups, and both dosages were well tolerated over a period of 18 months,” said Dr Holz, Professor and Chair, Department of Ophthalmology, University of Bonn, Germany.

GATHER1 consisted of two parts and randomised 286 participants who were treated with sham or avacincaptad pegol 1mg, 2mg or 4mg. The 1mg dose was not included in the prespecified primary statistical analysis.

The study’s eligibility criteria required that subjects have nonfoveal GA secondary to dry AMD with a total GA lesion area between 2.5 and 17.5mm2 and at least one focal lesion of 1.25mm2 if the GA was multifocal. BCVA in the study eye had to be between 20/25 and 20/320 on the ETDRS chart. Patients with choroidal neovascularisation (CNV) in either eye were excluded.

REDUCTION IN LESION GROWTH RATE
The primary efficacy endpoint was mean rate of change in GA lesion size over 12 months measured by fundus autofluorescence imaging. Data collected at 18 months showed that compared with the sham group, there was a 28% reduction in lesion growth rate in the group treated with avacincaptad pegol 2mg and a 30% difference for the 4mg group.

The investigational treatment was well tolerated, without any drug-related adverse events or drug-related inflammation.

“The most frequently reported ocular adverse events were related to the injection procedure,” said Dr Holz.The rate of CNV development in study eyes in the sham, avacincaptad pegol 2mg, and avacincaptad pegol 4mg arms was 2.7%, 9% and 9.6%, respectively. The overall incidence of CNV development in untreated fellow eyes was 3.5%.

The GATHER1 results were recently published in the journal Ophthalmology (August 31, 2020).

GATHER2, a confirmatory pivotal trial, is now under way. GATHER2 has a planned enrolment of approximately 400 patients. Patients will receive their assigned treatment every four weeks. The primary efficacy endpoint is the same as in GATHER1.

Frank Holz: frank.holz@ukb.uni-bonn.de