Astellas Pharma US, Inc. announced results from a post hoc analysis showing its drug IZERVAY reduced the risk of progressing to loss of driving eligibility in patients with geographic atrophy secondary to age-related macular degeneration.

The analysis pooled data from the GATHER1 and GATHER2 pivotal studies and was presented at the Association for Research in Vision and Ophthalmology Annual Meeting in Denver, Colorado. The study included 403 patients who were eligible to drive at baseline, defined by best-corrected visual acuity of at least 70 letters.

At 24 months, the risk of progressing to loss of driving eligibility was 12.6% for patients receiving IZERVAY monthly or every-other-month compared to 20.1% for those receiving sham treatment, representing a 41% relative risk reduction. For patients receiving IZERVAY monthly dosing only versus sham, the risk was 15.1% compared to 20.1% for sham, a 35% reduction in relative risk.

The company noted that given the exploratory post hoc nature of the data, results should be interpreted with caution and cannot be considered conclusive.

Separately, data from the GATHER2 open-label extension study showed IZERVAY was well-tolerated with no new safety signals, no cases of retinal vasculitis or occlusive vasculitis, and no increased risk of intraocular inflammation.

The extension study data also demonstrated sustained slowing of geographic atrophy lesion growth over time. Mean change in lesion growth area from months 24 to 42 was reduced by 40.5% versus projected sham in participants who switched from IZERVAY to monthly dosing at 3.5 years, and by 37% versus projected sham in the monthly group who previously received sham.

IZERVAY is approved for the treatment of geographic atrophy in the United States, Australia, Macau and conditionally in Japan. Astellas Pharma (Tokyo: 4503) continues to engage with regulatory authorities worldwide to bring the treatment to patients globally.