Astellas Pharma Inc. announced plans to present significant new data on geographic atrophy (GA) at two major ophthalmology conferences in May 2025. The company will showcase findings from its IZERVAY™ (avacincaptad pegol intravitreal solution) clinical program at the Association for Research in Vision and Ophthalmology Annual Meeting (ARVO) in Salt Lake City, Utah (May 4-8) and the Retina World Congress (RWC) in Fort Lauderdale, Florida (May 8-11).
The presentations will feature nine abstracts, including two oral presentations, highlighting analyses on biomarkers, patient experience, and mechanism of disease from the GATHER Phase 3 clinical studies of IZERVAY for the treatment of GA secondary to age-related macular degeneration (AMD).
"Recognizing the early indicators and disease pathways of geographic atrophy are critical to helping patients preserve their existing vision for longer," said Marci English, Senior Vice President of Biopharma and Ophthalmology Development at Astellas Pharma. "We look forward to engaging with the retina community at ARVO and RWC to discuss the latest scientific insights in early diagnosis and effective management of GA."
Key Research Highlights
The scientific presentations will cover several important aspects of GA research:
- Structure-function relationship between baseline central subfield ellipsoid zone (EZ) integrity and visual acuity at baseline and future vision loss (oral presentation)
- Baseline EZ integrity features linked to GA progression in eyes with differential shifts in GA growth rate (oral presentation)
- Multiple poster presentations evaluating imaging data from the GATHER1 and GATHER2 studies, which link structure and function in GA
- Two preclinical posters providing structural insights that refine the mechanism of action, pharmacokinetics, and pharmacodynamics of avacincaptad pegol (ACP)
- Data from qualitative studies assessing the experience of patients with GA in the United States, Spain, Germany, and France, including the impact of disease symptoms on health-related quality of life and coping mechanisms
Understanding Geographic Atrophy
Geographic atrophy represents an advanced form of dry age-related macular degeneration, which is the major cause of moderate and severe central vision loss in aging adults. The condition typically affects both eyes in most patients.
The disease process involves the progressive loss of retinal cells and underlying blood vessels in the macula—a small area in the central portion of the retina responsible for central vision. This deterioration results in marked thinning and atrophy of retinal tissue, leading to irreversible vision loss.
IZERVAY Treatment for Geographic Atrophy
IZERVAY (avacincaptad pegol intravitreal solution) is a C5 inhibitor approved in the United States for the treatment of GA. The drug is administered as an intravitreal injection and works by targeting the complement cascade, a key pathway implicated in the pathogenesis of GA.
The efficacy and safety of IZERVAY were established in the GATHER1 and GATHER2 clinical trials, both randomized, double-masked, sham-controlled, multicenter Phase 3 studies. These trials evaluated monthly 2 mg intravitreal administration of IZERVAY in patients with GA secondary to AMD.
The GATHER1 trial enrolled 286 participants, while GATHER2 included 448 participants. The primary efficacy endpoints in both pivotal studies were based on GA area measured by fundus autofluorescence at baseline, month 6, and month 12. Safety was evaluated in over 700 patients with GA across the two trials.
Clinical Trial Design and Results
In the first year of both GATHER trials, patients were randomized to receive either IZERVAY 2 mg or sham monthly. For the second year of the GATHER2 study, patients previously treated with IZERVAY were re-randomized to receive either monthly dosing (EM, n=96) or every other month dosing (EOM, n=93), while those who received sham in year 1 continued with sham treatment (n=203).
IZERVAY met its primary endpoint in both the GATHER1 and GATHER2 clinical trials. The drug is currently being evaluated in an ongoing open-label extension study.
Safety Considerations
As with any intravitreal injection, IZERVAY carries risks of side effects. The most common adverse reactions reported in clinical trials included blood in the white of the eye, increased eye pressure, blurred vision, and development of wet age-related macular degeneration.
Patients are advised not to receive IZERVAY if they have an infection or active swelling in or around the eye. Healthcare providers should monitor patients for potential complications such as eye infection (endophthalmitis), retinal detachment, and increased intraocular pressure following injection.
Advancing Understanding of GA
The upcoming presentations at ARVO and RWC represent Astellas' ongoing commitment to advancing the scientific understanding of GA and improving patient outcomes. By sharing insights on biomarkers, disease mechanisms, and patient experiences, the company aims to enhance early diagnosis and effective management strategies for this progressive and vision-threatening condition.
For healthcare professionals treating patients with GA, these new data may provide valuable insights into predicting disease progression, optimizing treatment approaches, and better understanding the patient experience with this challenging condition.
