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FDA Accepts Oxular’s IND Application for the Treatment of Diabetic Macular Edema

January 26, 2023

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.”