OXU-001 is being developed to provide retinal specialists with a potent, long-lasting, safe, and broad-acting anti-edema and anti-inflammatory for the treatment of DME, RVO and uveitis. Given this product profile, there is potential to expand OXU-001 development to radiation maculopathy and specifically to radiation-induced macular edema.
OXU-001 are dexamethasone-containing Oxuspheres that are designed to be delivered via Oxulumis to the posterior suprachoroidal space as a highly efficacious, well-tolerated and durable treatment.
In 12-month GLP preclinical studies, OXU-001 was well-tolerated, and related pharmacokinetic data confirmed that therapeutic drug levels were consistently maintained in target retinal tissues. Throughout the study period, only low drug levels were observed in off-target tissues associated with steroid side effects, including the vitreous and lens. This data supports expectations that OXU-001 will provide long-lasting treatment effects, with a meaningfully improved clinical safety profile.
DME patients are likely to have several underlying health issues and are often managed by multiple healthcare professionals. The burden of medical visits for these patients, who are typically of working age, frequently results in missed treatments and suboptimal treatment outcomes. OXU-001 has the potential to address the significant unmet needs of these patients through (i) long treatment durability and significantly fewer injections; (ii) better efficacy through sustained treatment benefits; (iii) better safety through tissue-specific delivery and minimized off-target side effects; and (iv) routine administration through minimally invasive microcatheterization to the suprachoroidal space.