Astellas reported post hoc Phase 3 GATHER trial data showing IZERVAY reduced the risk of loss of driving eligibility by up to 41% in patients with geographic atrophy secondary to AMD, with sustained long-term efficacy and no new safety signals observed through 42 months.
Written By: Sana Khan, BPharm
Reviewed By: Pharmacally Editorial Team
Astellas Pharma presented post hoc analysis results from the Phase 3 GATHER1 (NCT02686658) and GATHER2 (NCT04435366) trials at the Association for Research in Vision and Ophthalmology Annual Meeting showing that IZERVAY (avacincaptad pegol intravitreal solution) reduced the risk of progressing to loss of driving eligibility in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The findings suggested treatment benefits increased over time.
The analysis included 403 patients eligible to drive at baseline, defined as best-corrected visual acuity (BCVA) of at least 70 Early Treatment Diabetic Retinopathy Study (ETDRS) letters in the study eye. Baseline BCVA was similar between the IZERVAY and sham groups. At 24 months, 12.6% of patients receiving monthly or every-other-month IZERVAY progressed to driving ineligibility, defined as BCVA of 60 ETDRS letters or fewer at two consecutive visits, compared with 20.1% in the sham group, representing a 41% relative risk reduction. In the monthly dosing arm alone, the risk was 15.1% versus 20.1% with sham, corresponding to a 35% relative risk reduction. Investigators noted that the findings were exploratory and post hoc and should be interpreted cautiously.
In GATHER1, patients received monthly 2 mg IZERVAY or sham for 18 months. In GATHER2, patients initially received monthly dosing for 12 months before re-randomization to monthly or every-other-month treatment through month 24.
Margaret Chang, MD, MS, Retinal Consultants Medical Group, Sacramento, Calif said the findings suggest that slowing GA progression may help patients maintain vision-dependent daily activities, including driving, for longer periods.
Data from the GATHER2 open-label extension study through month 42 showed that IZERVAY remained well tolerated, with no new safety signals and no cases of retinal vasculitis or occlusive vasculitis. From months 24 to 42, GA lesion growth was reduced by 40.5% in patients switched to monthly IZERVAY dosing and by 37% in patients who switched from sham to monthly IZERVAY, compared with projected sham treatment (p<0.001 for both).
Marci English, Senior Vice President, Biopharma and Ophthalmology Development, Astellas Pharma said the results further support IZERVAY’s long-term effect on slowing GA progression and preserving vision-related function.
IZERVAY, a complement C5 inhibitor, is approved for the treatment of GA secondary to AMD in the United States, Australia, Macau, and conditionally in Japan. Geographic atrophy is an advanced form of dry AMD that causes irreversible vision loss through progressive retinal degeneration.
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About the Writer
Sana Jamil Khan (LinkedIn) is a B. Pharm graduate with a strong interest in medical writing and scientific communication. Her work focuses on interpreting clinical research, exploring developments in pharmaceutical science, and presenting complex medical information in a clear and accessible manner. She is particularly interested in topics related to human clinical studies, drug safety observations, and emerging therapeutic research.