UK-based Oxular Limited announced the US Food and Drug Administration has accepted its Investigational New Drug (IND) application for suprachoroidal OXU-001 for the treatment of diabetic macular oedema (DMO).
OXU-001 is dexamethasone formulated in Oxuspheres, a novel biodegradable drug preparation, for delivery to the posterior suprachoroidal space via Oxulumis, Oxular’s illuminated microcatheter. According to Oxular, this in-office treatment could lead to enhanced efficacy, favourable tolerability and extended durability to address key unmet needs for people with DMO and other retinal disorders.
In preclinical studies, OXU-001 was well-tolerated and pharmacokinetic data confirmed that therapeutic drug levels were consistently maintained in target retinal tissues for up to 12 months. The IND will enable advancement of the OXEYE phase 2 trial, which will evaluate the safety and efficacy of OXU-001, said Thomas Cavanagh, Oxular CEO. “Today’s treatment approaches have limited durability, requiring frequent anti-VEGF injections. Also, typically more than two Ozurdex implants per year may be required. The opportunity to provide patients with a targeted, in-office treatment just once a year could be a game-changer for this prevalent disease.”
