Astellas announced new findings from a post hoc analysis of the GATHER1 and GATHER2 studies showing that treatment with Izervay (avacincaptad pegol intravitreal solution) reduced the risk of progressing to loss of driving eligibility in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The data were presented at the Association for Research in Vision and Ophthalmology (ARVO) annual meeting in Denver, Colorado.

The analysis evaluated 403 patients who were eligible to drive at baseline, defined as having a best-corrected visual acuity (BCVA) score of at least 70 ETDRS letters. Researchers assessed the risk of patients progressing to loss of driving eligibility, defined as a BCVA score of 60 letters or fewer at two consecutive post-baseline visits over a 24-month period.

At study initiation, patients treated with Izervay and those receiving sham treatment had comparable vision scores, averaging 76.2 and 76.0 letters, respectively.

By month 24, the risk of progressing to loss of driving eligibility was 12.6% among patients receiving Izervay either monthly (EM) or every other month (EOM), compared with 20.1% in the sham group. The results represented a 41% relative risk reduction for Izervay treatment, with a nominal P-value of 0.0594. Patients who transitioned from monthly dosing to every-other-month dosing demonstrated similar outcomes.

When researchers evaluated only the monthly dosing cohort against sham treatment, the risk of progressing to loss of driving eligibility was 15.1% for Izervay versus 20.1% for sham, reflecting a 35% relative risk reduction, though the nominal P-value of 0.1584 did not reach statistical significance.

Investigators emphasized that, because the analysis was exploratory and conducted post hoc, the findings should be interpreted cautiously and are not considered conclusive.

The GATHER1 study evaluated monthly Izervay dosing versus sham treatment over 18 months, while GATHER2 treated patients monthly for 12 months before re-randomizing them to monthly or every-other-month dosing through month 24.

In a separate oral encore presentation at ARVO, Astellas also shared results from the open-label extension (OLE) phase of the GATHER2 study. The company reported that Izervay remained well tolerated with no new safety signals identified. Investigators observed no cases of retinal vasculitis or occlusive vasculitis and no increased risk of intraocular inflammation.

Longer-term exploratory data from the GATHER2 OLE study further demonstrated sustained slowing of GA lesion growth over time, with earlier treatment associated with greater preservation of healthy retinal tissue.

Between months 24 and 42, mean GA lesion growth area was reduced by 40.5% versus projected sham in patients who switched from monthly or every-other-month dosing to monthly Izervay treatment at 3.5 years. In patients who initially received sham before transitioning to monthly Izervay, lesion growth was reduced by 37% versus projected sham. Both findings achieved statistical significance with p-values below 0.001.

Izervay is currently approved for the treatment of GA in the United States, Australia and Macau, and conditionally approved in Japan. Astellas said it continues to work with regulatory authorities globally to expand access to the therapy for GA patients worldwide.