FDA Accepts Oxular’s IND Application for the Treatment of Diabetic Macular Edema
The U.S. Food and Drug Administration has approved Oxular Limited's investigational new drug application (IND) for suprachoroidal OXU-001 for the treatment of diabetic macular edema (DME).
The IND permits the OXEYE Phase 2 trial to proceed, which will assess the OXU-001 drug's efficacy and safety as well as its potential to offer retinal specialists a potent, long-lasting, secure, and broadly-acting anti-edema and anti-inflammatory treatment for retinal disorders with a high prevalence, starting with DME.
OXU-001 is dexamethasone formulated in a novel biodegradable drug preparation known as Oxuspheres®. OXU-001 will be delivered to the posterior suprachoroidal space of the eye via Oxulumis®, Oxular’s proprietary illuminated microcatheter. This in-office treatment could lead to enhanced efficacy, favorable tolerability, and extended durability to address key unmet needs for people with DME and other retinal disorders.
OXU-001 was well tolerated in 12-month preclinical tests, and related pharmacokinetic results supported that therapeutic drug levels were reliably maintained in the target retinal tissues. These findings imply that a single OXU-001 therapy could result in treatment effects lasting up to a year and a better clinical safety profile.
“The IND clearance for OXU-001 marks a significant milestone for Oxular,” said Thomas Cavanagh, Chief Executive Officer of Oxular. “DME is the most common and sight-threatening complication of diabetic eye disease and can be debilitating for patients who are often of working age. Today’s treatment approaches have limited durability, requiring frequent anti-VEGF injections into the eye. 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. We look forward to advancing OXU-001 into the clinic and evaluating its therapeutic impact in 2023.”
