Conference Presentation

Astellas to present GATHER1 driving-eligibility and EZ integrity data for IZERVAY at ASRS

New biomarker and functional analyses from the completed GATHER1 trial extend evidence behind the only approved complement inhibitor for geographic atrophy.

By AppliedXLJuly 14, 2026Trial NCT02686658

Executive Summary

Astellas is presenting additional biomarker and functional-outcome analyses from a trial that already met its primary endpoint and already supports an approved drug, extending rather than testing the evidence base.
The data bear on how photoreceptor-level biomarkers and real-world outcomes like driving eligibility translate into patient-relevant benefit, which matters for how the drug's profile is understood against the field's other complement-targeting programs.
IZERVAY remains the only approved complement inhibitor for this indication, with the nearest direct comparator, a cemdisiran-based Regeneron regimen, still in Phase 3 testing.
This is a maturation event on an established therapy, not a binary or hypothesis-testing catalyst, and its value is incremental evidence rather than a new decision point.

The presentation

Astellas announced on July 9, 2026 that it will deliver a podium presentation examining the relationship between ellipsoid zone integrity, an early biomarker of photoreceptor health, and low-luminance visual deficit in patients treated with IZERVAY. Additional presentations will cover a time-to-event analysis of driving eligibility maintenance, IZERVAY's effect on hyper transmission progression as a geographic atrophy biomarker, and real-world treatment patterns in patients receiving concomitant anti-VEGF therapy. The underlying trial, NCT02686658 (GATHER1), enrolled 286 participants across the United States, Hungary, Israel, Czechia, Estonia, Croatia, and Latvia, and completed with a primary completion date of September 26, 2019. Astellas+1

What the trial already established

GATHER1 tested avacincaptad pegol against sham injection, with change in geographic atrophy area by fundus autofluorescence at 12 months as the primary endpoint. The sponsor reported in November 2021 that the trial met that primary endpoint with statistical significance. A later pooled post hoc analysis of GATHER1 and its companion Phase 3 trial GATHER2 (NCT04435366), presented at ARVO in May 2026, found IZERVAY reduced the 24-month risk of progressing to loss of driving eligibility compared with sham, 12.6% versus 20.1%, a 41% relative risk reduction with a nominal p-value of 0.0594. Open-label extension data in that same analysis showed sustained 40.5% and 37% reductions in geographic atrophy growth against projected sham, both with p<0.001, and no new safety signals. IZERVAY subsequently received FDA approval for geographic atrophy in the United States, with additional approvals in Australia, Macau, and a conditional approval in Japan. NCT02686658+1

Quote

"Through IZERVAY, we continue to generate evidence that deepens our understanding of disease progression and patient-relevant outcomes," said Marci English, Senior Vice President, Biopharma and Ophthalmology Development at Astellas Pharma. The July 2026 ASRS presentations extend that evidence into biomarker mechanics, tying an anatomical marker, ellipsoid zone integrity, to a functional outcome, low-luminance visual deficit, rather than reporting a new controlled comparison. Astellas

The competitive frame

IZERVAY is the only industry asset that has reached Phase 3 with the C5 target specifically in geographic atrophy, with just four industry trials total spanning two sponsors in that indication-target pairing. The nearest direct comparator is Regeneron Pharmaceuticals' cemdisiran, in Phase 3 testing for geographic atrophy under NCT06541704, sharing both the C5 target and RNA-therapy modality. Of the two completed C5 programs in geographic atrophy on record, neither terminated, a small base that offers limited predictive weight given the small-denominator count. Given a field where no other C5 inhibitor for geographic atrophy has yet reached a completed readout, the informative bar for future disclosures is whether IZERVAY's functional-outcome gains, on driving eligibility and low-luminance vision, persist and extend as more patients accumulate longer follow-up, and whether Regeneron's cemdisiran-based regimen can reproduce a comparable functional signal when its own Phase 3 data mature.

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