IVERIC bio has reported that its investigational drug, avacincaptad pegol (ACP), met its primary endpoint in Phase III GATHER1 and the ongoing GATHER2 clinical trials for geographic atrophy (GA).
The randomised, double-masked, placebo-controlled, multi-centre pivotal Phase III trials assessed the efficacy and safety of monthly 2mg intravitreal ACP administration in patients with GA secondary to age-related macular degeneration (AMD).
For the initial 12 months, subjects were randomised to receive either ACP or a placebo monthly.
GATHER1 and GATHER2 enrolled 286 and 448 participants, respectively. Their primary efficacy endpoints were based on GA area measured by fundus autofluorescence at baseline, month six, and month 12.
The mean rate of growth (slope) in GA area to month 12 from baseline using observed data was found to be 35% in GATHER1 and 18% in GATHER2.
The clinical trials’ post-hoc analysis combined data showed a relationship between GA growth and worsening vision loss.
The data also signalled a risk reduction of 56% in the rate of persistent vision loss in GA patients receiving ACP 2mg against a placebo over the treatment period of the first 12 months.
Rand Eye Institute Vitreo-Retinal Services director Carl Danzig presented the findings at the Association for Research in Vision and Ophthalmology (ARVO) in the US.
Danzig said: “This is the first time a relationship between disease progression and worsening visual acuity has been observed in GA, connecting anatomy and function.
“These data suggest that in the ACP-treated group, the reduction in growth of GA resulted in an overall lower rate of vision loss.”