On July 5, 2022 IVERIC bio, Inc. (Nasdaq: ISEE) and DelSiTech Ltd, reported an exclusive global license agreement providing Iveric Bio with the right to develop and commercialize new formulations of Zimura (avacincaptad pegol) using DelSiTech’s silica-based sustained release technology (Press release, Ophthotech, JUL 5, 2022, View Source [SID1234616472]). As part of Iveric Bio’s lifecycle expansion plan for Zimura, the Company is committed to developing sustained release technologies for the treatment of age-related macular degeneration (AMD). These technologies potentially could address patients being treated for geographic atrophy (GA) and intermediate AMD.
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"We are thrilled to collaborate with the DelSiTech team on investigating additional sustained release formulations for Zimura with their drug delivery expertise and advanced technology and look forward to evaluating a sustained release formulation in GA and potentially earlier stages of AMD," stated Pravin U. Dugel, MD, President of Iveric Bio. "Previously reported post-hoc analyses from GATHER1 suggest that Zimura may have the potential to impact AMD in early stages before atrophy occurs in patients. We believe Zimura, which is a chemically synthesized RNA aptamer, is amenable to injectable sustained release formulations."
"As a leading developer of long-acting controlled release formulations for small molecules and biological entities, we are excited about collaborating with Iveric Bio on bringing innovative solutions to patients living with AMD," stated Lasse Leino, PhD, Chief Executive Officer of DelSiTech. "We are inspired by the opportunity to leverage our drug delivery technology to potentially help AMD patients early and improve their treatment experience."
"This agreement underscores our commitment to invest in lifecycle initiatives for Zimura," said Glenn P. Sblendorio, Chief Executive Officer of Iveric Bio. "We are excited about the possibilities to expand Zimura into earlier stages of AMD and potentially allow for a next-generation treatment to help patients with GA."
"We are proud to bring our competencies into this promising alliance and contribute to Iveric Bio’s mission to address unmet needs for patients," said Dr. Frederic Dargelas, Head of Business Development and Alliance Management for DelSiTech.
Under the terms of the license agreement, Iveric Bio will pay DelSiTech an upfront payment of €1,250,000, as well as development and commercial milestones and royalties on net sales of licensed products.
In addition to working with DelSiTech, Iveric Bio plans to explore the potential for Zimura in earlier stages of AMD by initiating a clinical trial studying the current formulation of Zimura in patients with intermediate AMD in the fourth quarter of 2022. The development strategy in this indication is subject to global regulatory feedback from the U.S. Food and Drug Administration (FDA) and other regulatory authorities, which Iveric Bio plans to obtain before initiating this trial.
About Zimura GATHER1 and GATHER2 Clinical Trials
Iveric Bio previously announced that GATHER1, the Company’s first Phase 3 clinical trial for Zimura (avacincaptad pegol) for GA, met its pre-specified primary efficacy endpoint with statistical significance. The most frequently reported ocular adverse events in this trial were related to the injection procedure. The Company expects topline data for GATHER2, the Company’s second Phase 3 clinical trial for Zimura for GA, to be available in the third quarter of 2022, approximately one year after the enrollment of the last patient in the trial plus the time needed for database lock and analysis. If 12-month results from GATHER2 are positive, the Company plans to submit applications with the FDA and the European Medicines Agency (EMA) for marketing approval of Zimura for GA. There are no FDA or EMA approved treatments available for patients with GA.
About Zimura
Zimura (avacincaptad pegol) is an investigational drug product and has not been approved for use anywhere globally. Zimura is designed to target and inhibit the cleavage of complement protein C5 and the formation of its downstream fragments, C5a and C5b. By inhibiting the formation of these fragments, Zimura is believed to decrease or slow the chronic inflammation and cell death associated with the retinal aging process by decreasing the formation of membrane attack complex (MAC) and inflammasome activity, thereby potentially avoiding or slowing the degeneration of retinal pigment epithelial cells. This potential mechanism is the rationale for Zimura as a potential therapy for GA and earlier stages of AMD.