Avacincaptad pegol

Despite the fail, Aviceda still plans to test its lead asset in two sham-controlled phase 3 trials in 2026.\n Aviceda Therapeutics has hit a snag in its goal to deliver a new treatment for geographic atrophy (GA), an advanced form of dry age-related macular degeneration. The biotech’s lead asset, AVD-104, failed to beat Astellas’ Izervay (avacincaptad pegol) at slowing the rate of retina lesion growth, missing the primary endpoint of a phase 2 trial.The trial enrolled 300 patients with GA and treated them with monthly eye injections of either Izervay or AVD-104 at low or high doses.\"The study did not meet its primary endpoint, which was designed to assess non-inferiority,\" a company spokesperson told Fierce Biotech. \"No statistical differences in GA lesion growth rates were observed across the three study arms.\"AVD-104 led to no serious adverse events, Aviceda reported in a Dec. 15 release, with the most common side effect being eye floaters. AVD-104 is a nanoparticle adorned with polysialic acid, designed to bind to receptors on the surfaces of overactive immune cells like macrophages that cause eye inflammation in GA.Though it failed to top Izervay, AVD-104 did reduce the growth rate of GA lesions by 31% compared to previously published sham-treatment rates from Izervay’s phase 3 trial, according to Aviceda. The company described this finding as “clinically meaningful.” In addition, the company highlighted that patients given AVD-104 were able to read an average of 0.6 more letters in a visual acuity test after 12 months of treatment.“These results reinforce our belief that AVD-104 can provide meaningful functional vision benefit while reducing lesion progression, and has the potential to become a differentiated therapy addressing a significant unmet medical need for patients living with GA,” Aviceda CEO Jeffrey Nau, Ph.D., said in the release. Despite the failure, which Aviceda attributed to “imbalances in key baseline lesion characteristics across treatment arms,” the company still plans to test its lead asset in two sham-controlled phase 3 trials in 2026, according to the release. The Massachusetts-based biotech closed a $207.5 million series C in January to support its phase 3 vision.Aviceda was also testing the nanoparticle in a phase 2 trial for diabetic macular edema, but halted the study early due to “insufficient study drug supply and study funding constraints,” according to the clinicaltrials.gov database.GA has been a tough indication for pharma to crack. Roche blockbuster hopeful lampalizumab flopped in a critical phase 3 trial in 2017, with the Swiss pharma subsequently ditching the asset. Novartis scrapped its own GA candidate, acquired from Gyroscope Therapeutics, in September 2023 because of weak data.And in September 2024, Alkeus Pharmaceuticals reported that its oral candidate failed to reduce GA lesion growth in a phase 3 trial, with the company nevertheless declaring the results “clinically meaningful.”Apellis\' Syfovre (pegcetacoplan) was the first GA drug to break through, securing FDA approval in February 2023. However, the med was flagged by the agency for rare cases of severe eye inflammation that can lead to blindness just months later. Astellas picked up Izervay through the $5.9 billion acquisition of Iveric Bio in March 2023, garnering an approval of its own that August.Neither Izervay nor Syfovre is able to restore vision, and injections of both come with the risk of side effects like inflammation, bleeding and blurred sight.Outside of therapeutics, Science Corp. announced in October that its retinal implant was able to give GA patients some vision back in a clinical trial.Editor\'s note: This story was updated at 4:00 p.m. ET with a statement from Aviceda.