Avacincaptad pegol

AMD is a significant cause of central vision loss in the elderly, often affecting both eyes. Credit: GBJSTOCK/Shutterstock. Astellas Pharma has announced the withdrawal of its marketing authorisation application for avacincaptad pegol intravitreal solution (ACP) to treat geographic atrophy (GA) secondary to age-related macular degeneration (AMD) from the European Medicines Agency (EMA). The withdrawal follows discussions with the EMA’s Committee for Medicinal Products for Human Use (CHMP). AMD is a significant cause of central vision loss in the elderly, often affecting both eyes. ACP, an investigational synthetic aptamer, inhibits the complement C5 protein. The overactivity of the complement system and C5 protein contributes to the scarring and vision loss associated with GA secondary to AMD. See Also: Pharma companies must adapt to keep pace with AI developments, say experts AF stroke patients could benefit from earlier anticoagulant administration By acting on C5, ACP reduces the activity of the complement system, which is implicated in the degeneration of retinal cells, potentially slowing the progression of GA. Astellas ophthalmology development vice-president and head Marci English stated: “We would like to emphasise our confidence in ACP’s clinical profile as demonstrated in two randomised sham-controlled trials and its potential to benefit people living with geographic atrophy (GA). “While we are disappointed with the CHMP’s response, we have seen the impact this medicine has had for GA patients in the US and remain committed to serving unmet patient needs globally.” Astellas is examining the possible financial effects of this issue for the fiscal year ending 31 March 2025. Despite the withdrawal, Astellas maintains a positive stance on ACP. The company continues to have confidence in ACP’s clinical profile and its potential to slow the disease. There are no currently approved treatments for GA secondary to AMD outside the US, where ACP was approved under the name IZERVAY in August 2023. Astellas will work with regulatory authorities to explore all available options to make ACP accessible to patients with GA globally, including those in Europe. Astellas recently received US Food and Drug Administration approval for VYLOY (zolbetuximab-clzb), in conjunction with chemotherapy, for the treatment of advanced gastric and gastroesophageal junction cancer.

CAMBRIDGE, Mass.--( BUSINESS WIRE )-- Aviceda Therapeutics , a private, clinical-stage biotech company focused on developing next-generation immunomodulators with a proprietary HALOS™ nanotechnology platform to alleviate chronic, non-resolving inflammation, announced today that the company completed enrollment of the Phase 2b SIGLEC study that compares the safety and efficacy of AVD-104 versus avacincaptad pegol (Izervay) in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). “We would like to thank our investigators and clinical development team for their extraordinary study execution achieving full enrollment the Phase 2b SIGLEC study in record time,” Mohamed Genead, MD, Aviceda’s Co-founder and CEO said. “We see the rapid enrollment as a reflection of the enthusiasm surrounding AVD-104 and its potential to significantly improve outcomes for patients with geographic atrophy.” “The current GA landscape contains a number of unmet needs,” commented David Callanan, MD , Aviceda’s Chief Medical Officer. “Based on our differentiated dual mechanisms of action and strong Phase 2a results, we believe AVD-104 has the potential to meaningfully alter the course of GA progression by enabling tangible functional benefits and neuroprotection of retinal tissue.” SIGLEC is a two-part clinical trial comprised of a Phase 2a and a Phase 2b study. Both studies are being conducted in the United States and are designed to evaluate the safety and efficacy of intravitreally administered AVD-104 in patients with GA secondary to AMD. In Phase 2a, researchers observed no drug-related ocular or systemic serious adverse reactions at 3 months following a single intravitreal injection of AVD-104 and concluded that the drug was well tolerated. Compared with untreated fellow eyes with GA at 3 months, as well as natural history, researchers also found that AVD-104 treatment led to greater reduction in GA lesion progression, improved hyperautofluorescence imaging outcomes in the junctional zone at the border of growing GA lesions, and stabilization or gain of best-corrected visual acuity (BCVA). SIGLEC Phase 2b is a multi-center, double-masked, randomized, controlled trial assessing the safety and efficacy of AVD-104 versus avacincaptad pegol (ACP) for the treatment of GA secondary to AMD. Approximately 300 participants with GA secondary to AMD, BCVA ≥20/320, and GA lesions ranging from 2.5 mm 2 to 17.5 mm 2 in size have been enrolled. Patients with exudative AMD, choroidal neovascularization, or any other ocular condition other than GA were excluded. Patients will be dosed for 12 months, with an opportunity to remain in the study for an additional 12 months. Participants will receive either high-dose AVD-104 every other month, low-dose AVD-104 monthly, or ACP monthly. The primary endpoint is the difference in growth rate of the GA area at 12 months in patients treated with AVD-104 versus those receiving ACP as measured by fundus autofluorescence. Further information regarding Phase 2b of SIGLEC can be found HERE . About Aviceda Therapeutics and AVD-104 Aviceda is a private, clinical stage biotechnology company located in Cambridge, MA, with a proprietary HALOS™ nanotechnology platform and a clinical stage ophthalmic candidate, AVD-104, for the treatment of geographic atrophy secondary to age-related macular degeneration (AMD). AVD-104 is a promising intravitreal glycan-coated nanoparticle with a dual mechanism of action that modulates critical inflammatory cellular and complement pathways through 1) direct deactivation of inflammatory microglia/macrophages’ phagocytic activity and repolarization of these activated microglia/macrophages to their healing state and 2) inhibition of complement cascade amplification. Along with AVD-104, Aviceda has a broad pipeline of products in development in ophthalmology and multiple other therapeutic areas, including immunology, fibrosis, oncology, and neurology. Learn more about Aviceda Therapeutics .