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Ixoberogene soroparvovec (Ixo-vec) intravitreal gene therapy for neovascular age-related macular degeneration (nAMD): Program update

Presenter:

Glenn Yiu, MD, PhD

Authors:

Glenn Yiu, MD, PhD

Department of Ophthalmology & Vision Science, University of California, Davis Health, Sacramento, CA 95817

Affiliation:

Purpose:

Frequent injections and vision decline limit long-term outcomes in patients with nAMD. Ixoberogene soroparvovec (Ixo-vec) gene therapy delivers sustained levels of aflibercept (AFL) with a single intravitreal (IVT) injection. The 5-year OPTIC trial (2 years plus a 3-year extension) evaluated the long-term safety and durability of Ixo-vec, whereas LUNA is a multicenter, randomized, double-masked, Phase 2 study in previously treated patients with nAMD who have demonstrated response to anti-vascular endothelial growth factor (anti-VEGF) therapy. Here, we report updates to the efficacy and safety of Ixo-vec in the OPTIC and LUNA trials.

Methods:

In OPTIC (NCT04645212), patients with nAMD and a high anti-VEGF treatment burden received a single IVT injection of Ixo-vec at 2x1011 (2E11) vg/eye with steroid prophylaxis. In LUNA (NCT05536973), patients with nAMD were randomized across two Ixo-vec doses, 6x1010 vg/eye (6E10) and 2E11, with different corticosteroid prophylactic regimens. We report the best-corrected visual acuity (BCVA), change in central subfield thickness (CST), patient treatment preference, adverse events (AEs), and aqueous AFL levels in these studies.

Results:

Prior to OPTIC and LUNA, patients were heavily treated, receiving approximately 10.0 mean annualized anti-VEGF injections. In OPTIC, patients demonstrated an 87% reduction in annualized injection burden, with 47% of patients becoming anti-VEGF injection-free over 4 years. Ixo-vec maintained a mean BCVA of -2.9 ETDRS letters and mean CST improvement of -117.7µm from baseline. In LUNA, previously treated patients showed a reduction in treatment burden with 54% (6E10) and 69% (2E11) of patients remaining injection free at week 52. BCVA and CST remained stable with least-squares-mean change of -2.1 (6E10) and -1.8 (2E11) ETDRS letters and -10.2µm (6E10) and ‑21.9µm (2E11), respectively. 93% of patients preferred Ixo-vec over their prior anti-VEGF therapy. All Ixo-vec-related AEs were mild or moderate, with no serious AEs across both trials. Long-term aqueous AFL levels were sustained in both OPTIC and LUNA patients.

Conclusions:

In OPTIC and LUNA, Ixo-vec was well tolerated and maintained visual and anatomic endpoints in patients with nAMD, even with the lowest dose (6E10). Injection burden was meaningfully reduced in patients who previously needed frequent anti-VEGF treatment.

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