Iveric Bio to Present Top-line Results for Avacincaptad Pegol from Phase 3 GATHER2 Clinical Trial in Geographic Atrophy at AAO 2022 Annual Meeting
“We look forward to engaging with the professional eye care community at AAO 2022 and presenting findings from GATHER2, our second pivotal study of avacincaptad pegol in geographic atrophy,” stated
The findings will be presented during an oral session titled, “First-time Results of Clinical Trials,” as part of Retina Subspecialty Day 1. Details of the presentations are as follows:
Presentation Title: GATHER2 Pivotal Phase 3 Study Results: Efficacy of Intravitreal Avacincaptad Pegol in Geographic Atrophy
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Presenter:
Arshad M. Khanani , MD, MA, FASRS, Director of Clinical Research atSierra Eye Associates ,Reno, Nevada -
Date/Time:
September 30, 2022 /4:18 PM
Presentation Title: GATHER2 Pivotal Phase 3 Study Results: Safety of Intravitreal Avacincaptad Pegol in Geographic Atrophy
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Presenter:
Jeffrey S. Heier , MD, Co-President & Medical Director,Ophthalmic Consultants ofBoston ,Boston, MA -
Date/Time:
September 30, 2022 /4:24 PM
“We would like to thank the
About Geographic Atrophy
Age-related macular degeneration (AMD) is the major cause of moderate and severe loss of central vision in aging adults, affecting both eyes in the majority of patients. The macula is a small area in the central portion of the retina responsible for central vision. As AMD progresses, the loss of retinal cells and the underlying blood vessels in the macula results in marked thinning and/or atrophy of retinal tissue. Geographic atrophy, the advanced stage of AMD, leads to further irreversible loss of vision in these patients. There are currently no
About Avacincaptad Pegol
Avacincaptad pegol (also known as ACP or Zimura®) is an investigational drug that has not been evaluated for safety or efficacy in any country. ACP is a novel complement C5 protein inhibitor. Overactivity of the complement system and the C5 protein are suspected to play a critical role in the development and growth of scarring and vision loss associated with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). By targeting C5, ACP has the potential to decrease activity of the complement system that causes the degeneration of retinal cells and potentially slow the progression of GA.
About the GATHER2 Clinical Trial
In GATHER2, 448 participants were enrolled in the international, randomized, double-masked, sham-controlled, multicenter clinical trial to measure the efficacy and safety of monthly 2 mg intravitreal administration of ACP in patients with GA. For the first 12 months, patients were randomized to receive either ACP 2 mg or sham monthly. At 12 months, participants in the ACP arm were re-randomized to either receive ACP 2 mg once monthly or every other month until month 23 of the study. The final evaluation will take place at month 24.
About
Forward-looking Statements
Any statements in this press release about the Company’s future expectations, plans and prospects constitute forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Forward-looking statements include any statements about the Company’s strategy, future operations and future expectations and plans and prospects for the Company, and any other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend”, “goal,” “may”, “might,” “plan,” “predict,” “project,” “seek,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions. In this press release, the Company’s forward-looking statements include statements about its expectations regarding the results and implications of the clinical data from its GATHER2 trial of ACP in geographic atrophy, its development and regulatory strategy for ACP, including its plans to submit a new drug application to the
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Senior Vice President, Investor Relations
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