Phase 111 GATHER 2 Clinical Trial shows Astellas' IZERVAY™ reduces GA lesion growth
Published on MedED: 23 January 2024
Originally published: 23 November 2023
Source: Astellas Press Release
Type of article: Novel Drug & Emergent Therapy News
MedED Catalogue Reference: MNDN006
Category: Ophthalmology
Crossreference: AMD, Global Atrophy
Category tags: Chronic retinal conditions, AMD, global atrophy
Originally published: 23 November 2023
Source: Astellas Press Release
Type of article: Novel Drug & Emergent Therapy News
MedED Catalogue Reference: MNDN006
Category: Ophthalmology
Crossreference: AMD, Global Atrophy
Category tags: Chronic retinal conditions, AMD, global atrophy
| Product Category | Product Name | Company | Status |
|---|---|---|---|
| Phase 3 Trials |
Astellas Press Release, 23 November 2024
Astellas Pharma Inc. announced results from the GATHER2 Phase 3 clinical trial for IZERVAY™ (avacincaptad pegol intravitreal solution), showing continued reduction in geographic atrophy (GA) lesion growth in patients with age-related macular degeneration (AMD) over two years. Key findings include:
IZERVAY™ significantly reduced the rate of GA lesion growth compared to sham, with a 14% reduction in the every-month (EM) dosing group and a 19% reduction in the every-other-month (EOM) dosing group at two years.
Treatment benefits were observed as early as six months and continued to increase over time, more than doubling over two years compared to year one.
The study did not meet its primary objective of demonstrating a reduction in ≥15-letter persistent vision loss over two years, but further analyses will be conducted.
IZERVAY™showed a favorable safety profile over two years, with no new safety signals identified. Adverse events were consistent with those observed in year one.
The most common ocular adverse events were conjunctival haemorrhage, increased intraocular pressure, and choroidal neovascularization.
IZERVAY™was approved by the FDA in August 2023 for GA secondary to AMD and is currently under review by the European Medicines Agency.
Clinical Trials & Supporting Information
| Clinical Study | ClinicalTrial.gov Registration | ClinicalTrial.gov Registration |
|---|---|---|
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This article is compiled from a variety of resources. Every effort has been made to correctly attribute quotes and content. Where possible all information has been independently verified. The Medical Education Network bears no responsibility for any inaccuracies which may occur from the use of third-party sources. If you have any queries regarding this article contact us
Fact-checking Policy
The Medical Education Network makes every effort to review and fact-check the articles used as source material in our summaries and original material. We have strict guidelines in relation to the publications we use as our source data, favouring peer-reviewed research wherever possible. Every effort is made to ensure that the information contained here is an accurate reflection of the original material. Should you find inaccuracies, out of date content or have any additional issues with our articles, please make use of the contact us form to notify us.
