Oxular Limited Announces Acceptance of IND for Suprachoroidal OXU-001 for the Treatment of Diabetic Macular Edema

OXU-001 represents potential best-in-class treatment for DME with just one, targeted administration per year

Initiation of OXEYE Phase 2 clinical trial of OXU-001 in DME patients on-track for first quarter of 2023; Initial clinical data on safety and durability expected in 2023

OXFORD, United Kingdom--(BUSINESS WIRE)--Oxular Limited, a clinical-stage ophthalmic company developing long-lasting targeted treatments for retinal disorders to improve patients’ vision, today announced that the U.S. Food and Drug Administration has accepted its Investigational New Drug Application (IND) for suprachoroidal OXU-001 for the treatment of diabetic macular edema (DME). The IND enables advancement of the OXEYE Phase 2 trial, which will evaluate the safety and efficacy of OXU-001 and the potential to provide retinal specialists with a potent, long-lasting, safe, and broad-acting anti-edema and anti-inflammatory treatment for high-prevalence retinal disorders, beginning 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.

In 12-month preclinical studies, OXU-001 was well-tolerated and related pharmacokinetic data confirmed that therapeutic drug levels were consistently maintained in target retinal tissues. These data suggest that a single treatment of OXU-001 may provide up to twelve-month treatment effects with an improved 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.”

About Oxular

Oxular is a biotechnology company developing long-lasting retinal treatments, delivered suprachoroidally, to improve patients’ vision so they can live better lives. The company has engineered sustained-release drug formulations designed to last up to one year following single dosing and delivery technology to access tissues in the posterior suprachoroidal space via routine, in-office administration. This unique combination aims to substantially improve patients’ vision by increasing therapeutic effectiveness, while reducing side-effects and minimizing the frequency of treatments. Oxular is developing a deep portfolio of product candidates that includes treatments for prevalent retinal diseases, such as diabetic macular edema and diabetic retinopathy. For more information, please visit Oxular.com.