PARSIPPANY, N. J. –( BUSINESS WIRE )– IVERIC bio, Inc. (Nasdaq: ISEE) announced today that top-line efficacy and safety results through 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 a few. Following previously announced positive topline findings, this is the first time GATHER2 results for avacincaptad pegol is going to be presented at a medical congress.

“We look forward to engaging with the professional eye care community at AAO 2022 and presenting results from GATHER2, our following pivotal study of avacincaptad pegol inside 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 three or more studies that will 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 associated with the first quarter of 2023 plus bringing a potential new treatment for GA to physicians and their own patients. ”

The findings will be presented during an oral session titled, “First-time Results of Medical 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 associated with Clinical Research at Sierra Eye Associates, Reno, Nevada
• Date/Time: September 30, 2022 / 4: 18 PM

Demonstration Title: GATHER2 Pivotal Stage 3 Research Results: Safety of Intravitreal Avacincaptad Pegol in Geographic Atrophy

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

“We would like to thank the particular American School of Ophthalmology for the opportunity to share the results of GATHER2 with eye care specialists from around the world in the 2022 annual meeting, ” said Pravin U. Dugel, MD, President associated with 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 with regard to patients along with GA. ”

Iveric Biography will make the slide presentations available in the particular 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 within aging adults, affecting both eyes in the majority associated with patients. The macula will be a small area within the central portion of the retina responsible regarding central vision. As AMD progresses, the loss of retinal cells and the underlying blood vessels in the macula results within marked thinning and/or atrophy of retinal tissue. Geographic atrophy, the particular advanced stage of ADVANCED MICRO DEVICES, leads to further irreversible reduction of eyesight in these patients. There are currently no Circumstance. S. Food and Drug Administration (FDA) or European Medicines Agency (EMA) approved treatment options available intended for patients with geographic atrophy.

Regarding Avacincaptad Pegol

Avacincaptad pegol (also known as ACP or Zimura ^® ) is an investigational drug that has not been evaluated for security or effectiveness in any country. ACP is a novel complement HANDSET protein inhibitor. Overactivity associated with the complement system as well as 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 in order to decrease activity of the complement system that causes the deterioration of retinal cells plus potentially slow the progression of GA.

About the GATHER2 Scientific Trial

In GATHER2, 448 participants were enrolled in the international, randomized, double-masked, sham-controlled, multicenter clinical test to measure the efficacy and safety of monthly 2 mg intravitreal administration associated with ACP inside patients along with GA. For the first a year, patients were randomized to receive either ACP 2 mg or sham monthly. At 12 months, participants in the ACP arm had been re-randomized to either receive ACP two mg once monthly or even every other month until month 23 of the research. The final evaluation will take place from month twenty-four.

About Iveric Bio

Iveric Bio will be a science-driven biopharmaceutical company focused on the discovery and advancement of novel treatments to get retinal diseases with significant unmet medical needs. The Company is devoted 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 plus prospects constitute forward-looking statements for purposes of the particular safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Forward-looking statements include any claims about the Company’s strategy, future operations and future expectations and plans plus prospects pertaining to 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 claims about its expectations regarding the results and implications from the clinical data from the GATHER2 demo of ACP in geographic atrophy, its development plus regulatory technique for ACP, including the plans in order to submit a brand new drug software to the particular U. H. As well as Drug Administration, and the potential utility associated with ACP in treating geographic atrophy. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company’s growth programs, long term results, performance, or achievements to differ significantly through those expressed or implied by the forward-looking statements. Such risks plus uncertainties consist of, among others, those related to anticipation for regulatory matters, interpretation of clinical trial outcomes from the scientific and clinical community, developments from the Company’s competitors and the marketplace for the particular Company’s products, and other factors discussed in the “Risk Factors” section contained within the quarterly and yearly reports that the Company files with the Securities plus Exchange Commission. Any forward-looking statements represent the Company’s views only as of the particular date of this pr release. The Organization anticipates that will subsequent events and advancements may cause its views to change. While the Company may elect in order to update these types of forward-looking statements at some point in the future, the Business specifically disclaims any obligation to do so except as required by law.