Astellas Pharma reported findings from a post hoc analysis of the GATHER1 and GATHER2 clinical trials showing that IZERVAY (avacincaptad pegol intravitreal solution) reduced the risk of patients with geographic atrophy (GA) progressing to loss of driving eligibility over 24 months.
The analysis, presented at the Association for Research in Vision and Ophthalmology Annual Meeting, pooled data from 403 patients with GA secondary to age-related macular degeneration who were eligible to drive at baseline. At study initiation, visual acuity was similar between treatment groups, with patients receiving IZERVAY or sham measuring 76.2 and 76.0 letters, respectively.
After 24 months, 12.6% of patients treated with IZERVAY monthly or every other month progressed to loss of driving eligibility, compared with 20.1% in the sham group, representing a 41% relative risk reduction. In a separate analysis of monthly dosing alone, the risk was 15.1% for IZERVAY versus 20.1% for sham, a 35% relative risk reduction. The company noted the findings are exploratory and should be interpreted with caution.
The trials defined loss of driving eligibility as best-corrected visual acuity of 60 letters or fewer at two consecutive visits. Patients in GATHER1 received IZERVAY or sham for 18 months, while GATHER2 included a 12-month treatment period followed by re-randomization to monthly or every-other-month dosing through 24 months.
“Geographic atrophy is a progressive disease associated with vision loss that can affect many aspects of daily life, including the ability to drive,” said Margaret Chang, MD, of Retinal Consultants Medical Group. “Findings from this study suggest IZERVAY slows GA progression, which could allow some patients to continue to do the things they love for longer.”
Additional data from the GATHER2 open-label extension study showed IZERVAY was well tolerated, with no new safety signals and no reported cases of retinal vasculitis, occlusive vasculitis, or increased intraocular inflammation. Longer-term results indicated sustained slowing of GA lesion growth, with earlier treatment associated with greater preservation of healthy retinal tissue.
From months 24 to 42, GA lesion growth was reduced by 40.5% versus projected sham in patients who switched to monthly IZERVAY dosing at 3.5 years, and by 37% in those who had previously received sham before transitioning to IZERVAY (p<0.001 for both comparisons).
“Findings highlighting sustained slowing of disease progression and the potential impact on vision-dependent functions like driving reflect our focus on developing therapies that can make a meaningful difference for people living with GA,” said Marci English, senior vice president of biopharma and ophthalmology development at Astellas.
IZERVAY is approved for the treatment of GA in the United States, Australia, Macau, and conditionally in Japan, with ongoing regulatory engagement in additional markets.
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