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.

Contacts

Monique Allaire

THRUST Strategic Communications

[email protected]