Arshad Khanani, MD: Two-Year Results from GATHER2 Trial

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Phase 3 results from the GATHER2 trial show the treatment effect of avacincaptad pegol for geographic atrophy more than doubled over 2 years compared to year 1 of study.

New data from the phase 3 GATHER2 clinical trial showed avacincaptad pegol (IZERVAY) continued to reduce the rate of geographic atrophy (GA) lesion growth over 2 years, with both every-month and every-other month dosing versus sham in patients with GA secondary to age-related macular degeneration (AMD).

According to the study results, presented at the 127th Annual American Academy of Ophthalmology (AAO) Meeting in San Francisco, California, the treatment benefit with avacincaptad pegol was noted as early as 6 months, continued to increase over time through 2 years, and more than doubled over 2 years, compared to year 1.

“The two-year data from the GATHER2 study shows that every-other-month dosing can continue to benefit our patients with GA, and that’s important, as it can decrease the treatment burden,” said presenting investigator Arshad M. Khanani, MD, director of clinical research at Sierra Eye Associates, in an interview with HCPLive.

Avacincaptad pegol was approved by the US Food and Drug Administration (FDA) in August, marking the second approval for a complement inhibitor for GA secondary to AMD in 2023. The therapy is currently under review by the European Medicines Association.

The primary GATHER2 analysis endpoint at 2 years showed every-month avacincaptad pegol showed a statistically significant year-over-year reduction of 14% in the mean rate of GA growth from baseline versus sham (P = .0165). Every-other-month dosing, after a year of monthly dosing, led to a reduction of 19% in the mean GA growth rate at 2 years versus sham (P = .0015). Overall, the treatment effect was shown to more than double over 2 years, compared to 1 year.

A prespecified endpoint of reduction in the rate of ≥15-letter persistent vision loss with avacincaptad pegol, compared to sham, over 2 years, was found to be non-statistically significant. Safety analyses showed the therapy was well-tolerated over 2 years, with no cases of ischemic neuropathy or retinal vasculitis.

Serious ocular treatment-emergent adverse events over 2 years were equivalent between the avacincaptad pegol and sham groups (1.8% vs. 0.9%).A single case of culture-positive endophthalmitis and non-serious intraocular inflammation were observed in year 2 of GATHER2 for the avacincaptad pegol group, compared to no cases in the sham group.

For more insight into the GATHER2 two-year results, watch the full interview with Dr. Khanani.

References

IzervayTM (avacincaptad Pegol Intravitreal Solution) monthly or every other month reduced geographic atrophy lesion growth through 2 years. Iveric. November 4, 2023. Accessed November 9, 2023. https://ivericbio.com/izervay-avacincaptad-pegol-intravitreal-solution-monthly-or-every-other-month-reduced-geographic-atrophy-lesion-growth-through-2-years/.

Khanani AM, Patel SS, Staurenghi G, Tadayoni R, Danzig CJ, Eichenbaum DA, Hsu J, Wykoff CC, Heier JS, Lally DR, Mones J, Nielsen JS, Sheth VS, Kaiser PK, Clark J, Zhu L, Patel H, Tang J, Desai D, Jaffe GJ. GATHER2: Two-Year Data. Presented at the 2023 American Academy of Ophthalmology Annual Meeting, November 3 – 6, 2023.

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