These OLE analyses help us better understand IZERVAY’s role in GA management.”

– Dr. Arshad M. Khanani, Vitreoretinal Surgeon

IZERVAY was assessed in two Phase 3 trials and an OLE study through 3.5 years^2,5

EM=every month; EOM=every other month; FAF=fundus autofluorescence; IOP=intraocular pressure; LLD=low luminance deficit; LLVA=low luminance visual acuity; OE=ophthalmic examination.

*Patient re-randomization.

^†All participants, regardless of prior GATHER2 treatment (IZERVAY or sham), received IZERVAY in the study eye. All participants were to have a final follow-up visit or follow-up procedure at Month 42 if the study was terminated early. The end of the study was defined as the date of the last study assessment for the last participant in the study globally.

^‡Exploratory endpoints include the following ophthalmic variables: BCVA, LLVA, LLD, IOP, OE, and GA area.

The recommended dose for IZERVAY is 2 mg once monthly (approximately 28 +/- 7 days)²

The primary endpoint in GATHER1 and 2 evaluated the mean rate of GA growth (slope) from baseline to Month 12, measured by FAF at 3 time points (baseline, Month 6, and Month 12). In GATHER2, the mean rate of GA growth (slope) measured by FAF was evaluated at 2 additional time points (Month 18 and Month 24).²

Reductions in mean rate of growth (MMRM analysis) at 12 months vs sham²

CI=confidence interval; MMRM=mixed models for repeated measures.

^§6-month time point was not part of the primary analysis, is observational in nature and should be interpreted with caution, and cannot be considered conclusive.

^||Percent difference is calculated by 100×(difference)/(least squares mean from sham).

The annualized rate of GA growth (MMRM analysis)^# at 24 months in GATHER2²

The recommended dose for IZERVAY is 2 mg once monthly (approximately 28 ± 7 days)²

^¶Analysis is based on MMRM assuming a piecewise linear trend at Month 6, 12, 18, including effects for treatment, time, and time by treatment interaction.

^#Non-transformed GA growth slope analysis.

**Percent difference is calculated by 100×(difference)/(least squares mean from sham).

IZERVAY is the only FDA-approved GA treatment with no warning and precaution for intraocular inflammation or retinal vasculitis^2,4

• ≤1% of patients treated with IZERVAY for up to 24 months across the GATHER trials reported experiencing photopsia, ischemic optic neuropathy, vitreous hemorrhage, vitreal cells, vitritis, and endophthalmitis^2§§

No cases of retinal vasculitis were reported in the GATHER trials⁵

^††Blurred vision includes visual impairment, vision blurred, visual acuity reduced, visual acuity reduced transiently (and blindness transient for GATHER2 24 months).

^‡‡Punctate keratitis includes punctate keratitis and keratitis.

^§§Culture positive.

^||||As of 02/26. Based on samples and commercially distributed vials.

IZERVAY treatment duration⁵:

• IZERVAY to IZERVAY: 42 months
• Sham to IZERVAY: 18 months

Given the exploratory nature of the data, these results should be interpreted with caution and cannot be considered conclusive. The OLE analysis used a projected sham and may not reflect rate of change for all GA patients. Although prespecified, there was no statistical testing hierarchy. Open-label studies can allow for selection bias; clinical significance is not established.

Reductions in mean rate of growth (MMRM analysis) from Months 24 to 42 vs projected sham⁵

Methodology: For projected sham, GA growth rate from Month 24 to Month 42 was first calculated as the average transformed growth rates across four 6-month intervals (baseline through Month 24) in the GATHER2 sham group and subsequently converted to the untransformed scale.⁵

For the IZERVAY groups, a separate piecewise MMRM was applied using square root transformed GA area data. The least squares mean of the square root transformed GA area was calculated and converted to the untransformed scale.⁵