TOKYO (dpa-AFX) - Astellas Pharma Inc. (ALPMY) on Tuesday reported results from a post hoc analysis of its GATHER1 and GATHER2 pivotal studies, showing that treatment with IZERVAY reduced the risk of patients progressing to loss of driving eligibility compared with sham over 24 months in geographic atrophy (GA) associated with age-related macular degeneration.
The analysis focused on patients who were still eligible to drive at baseline, defined by best-corrected visual acuity of at least 70 ETDRS letters. Loss of driving eligibility was defined as a decline to 60 letters or less on two consecutive visits.
Across the two studies, patients received IZERVAY or sham, and the pooled long-term data suggested that the treatment benefit increased over time, with a lower risk of vision decline affecting driving eligibility.
Separately, long-term safety data from the GATHER2 open-label extension indicated that IZERVAY was generally well tolerated, with no new safety concerns observed. Importantly, there were no reported cases of retinal vasculitis or occlusive vasculitis, and no increase in intraocular inflammation, reinforcing the therapy's safety profile in patients with geographic atrophy secondary to age-related macular degeneration.
The findings were presented at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting in Denver, Colorado.
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