Iveric Bio to Present Top-line Results for Avacincaptad Pegol from Phase 3 GATHER2 Clinical Trial in Geographic Atrophy at AAO 2022 Annual Meeting

Rhea-AI Summary

Iveric Bio (Nasdaq: ISEE) announced that top-line efficacy and safety results from its GATHER2 Phase 3 clinical trial of avacincaptad pegol (Zimura) will be presented at the American Academy of Ophthalmology 2022 annual meeting from September 30 to October 3 in Chicago. This marks the first public presentation of GATHER2 results, which demonstrated meeting the pre-specified primary endpoint of slowing geographic atrophy (GA) progression at 12 months. The company plans to submit a new drug application to the FDA by the end of Q1 2023.

Positive

• Achieved positive top-line results in the GATHER2 Phase 3 trial.
• Met primary endpoints at 12 months, indicating effectiveness in slowing GA progression.
• Plans to submit a new drug application to the FDA by Q1 2023.

Negative

• None.

 

PARSIPPANY, N.J.--(BUSINESS WIRE)-- IVERIC bio, Inc. (Nasdaq: ISEE) announced today that top-line efficacy and safety results from GATHER2, the Company’s second Phase 3 clinical trial of avacincaptad pegol (ACP, also known as Zimura^®), an investigational complement C5 inhibitor being evaluated for the treatment of geographic atrophy (GA), will be presented at the American Academy of Ophthalmology 2022 annual meeting (AAO 2022) in Chicago, September 30 – October 3. Following previously announced positive topline findings, this is the first time GATHER2 results for avacincaptad pegol will be presented at a medical congress.

“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 Glenn P. Sblendorio, Chief Executive Officer of Iveric Bio. "We are excited to have achieved something that has never been done before in GA – deliver two Phase 3 studies that met their pre-specified, primary endpoint at 12 months of slowing GA progression. We are committed to moving forward with our plan to submit a new drug application to the FDA by the end of the first quarter of 2023 and bringing a potential new treatment for GA to physicians and their patients.”

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

• Presenter: Arshad M. Khanani, MD, MA, FASRS, Director of Clinical Research at Sierra 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

• Presenter: Jeffrey S. Heier, MD, Co-President & Medical Director, Ophthalmic Consultants of Boston, Boston, MA
• Date/Time: September 30, 2022 / 4:24 PM

“We would like to thank the American Academy of Ophthalmology for the opportunity to share the results of GATHER2 with eye care specialists from around the world at the 2022 annual meeting,” said Pravin U. Dugel, MD, President of Iveric Bio. “Geographic atrophy is a debilitating disease, for which there are no currently approved treatments. We believe avacincaptad pegol has the potential to be life-changing for patients with GA.”

Iveric Bio will make the slide presentations available in the Investors section of the company’s Web site following the presentations.

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 U.S. Food and Drug Administration (FDA) or European Medicines Agency (EMA) approved treatment options available for patients with geographic atrophy.

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 Iveric Bio

Iveric Bio is a science-driven biopharmaceutical company focused on the discovery and development of novel treatments for retinal diseases with significant unmet medical needs. The Company is committed to having a positive impact on patients’ lives by delivering high-quality, safe and effective treatments designed to address debilitating retinal diseases including earlier stages of age-related macular degeneration. For more information on the Company, please visit www.ivericbio.com.

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 U.S. Food and Drug Administration, and the potential utility of ACP in treating geographic atrophy. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company’s development programs, future results, performance, or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, those related to expectations for regulatory matters, interpretation of clinical trial results by the scientific and medical community, developments from the Company’s competitors and the marketplace for the Company’s products, and other factors discussed in the “Risk Factors” section contained in the quarterly and annual reports that the Company files with the Securities and Exchange Commission. Any forward-looking statements represent the Company’s views only as of the date of this press release. The Company anticipates that subsequent events and developments may cause its views to change. While the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so except as required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220926005525/en/

Investor:

Kathy Galante

Senior Vice President, Investor Relations

kathy.galante@ivericbio.com

or

Media:

Jeannie Neufeld

Senior Director, Public Relations & Communications

jeannie.neufeld@ivericbio.com

Source: IVERIC bio, Inc.

FAQ

What are the results of the GATHER2 trial for avacincaptad pegol?

The GATHER2 trial showed positive top-line efficacy and safety results in slowing geographic atrophy progression.

When will Iveric Bio present GATHER2 trial results?

Iveric Bio will present the GATHER2 trial results at the American Academy of Ophthalmology meeting from September 30 to October 3, 2022.

What is the next step for Iveric Bio after the GATHER2 trial?

Iveric Bio plans to submit a new drug application to the FDA by the end of the first quarter of 2023.

What is avacincaptad pegol being developed for?

Avacincaptad pegol is being developed as a treatment for geographic atrophy secondary to age-related macular degeneration.

How many participants were involved in the GATHER2 trial?

The GATHER2 trial enrolled 448 participants.