Oxular Limited announced that the FDA has accepted its investigational new drug (IND) application for the suprachoroidal OXU-001 to treat diabetic macular edema (DME).
Tell me about OXU-001.
OXU-001 is a sustained release dexamethasone formulation consisting of a novel biodegradable microsphere preparation called “Oxuspheres.” These microspheres are posited to deliver a precision daily dose of the medication to the target retinal and choroidal tissues.
It’s designed to be delivered to the eye’s posterior suprachoroidal area via OxuluUmis—Oxular’s proprietary, semi-automated ocular administration device that utilizes an illuminated microcatheter. While it’s currently being studied for DME, the company has plans for also using it to treat retinal vein occlusion (RVO) and uveitis. (via)
How did it perform in pre-clinical trials?
Twelve-month studies found OXU-001 to be well-tolerated. Pharmacokinetic data for the drug established its levels to be consistently maintained in target retinal tissues. There were also low drug levels present in off-target tissues related to steroid side effects, such as the vitreous and lens. (via)
What does that suggest?
The pre-clinical trial data proposed that just one OXU-001-administered treatment could supply up to 12 months of anti-inflammatory and anti-edema effects, along with an improved clinical safety profile.
What’s next?
The IND acceptance allows Oxular to move forward with their OXEYE phase 2 trial that will further assess OXU-001’s safety and efficacy for treating DME.
Significance?
The potential for OXU-001 as an in-office treatment, administered just once a year—compared to standard treatments of frequent anti-VEGF injections into the eye—has the potential to offer patients a longer-lasting, more efficient option for patients diagnosed with sight-threatening retinal diseases.