Oxular Limited Announces Acceptance of IND for Suprachoroidal OXU-001 for the Treatment of Diabetic Macular Edema
24.1.2023 16:00:00 EET | Business Wire | Press release
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.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230124005116/en/
Contact information
Monique Allaire
THRUST Strategic Communications
monique@thrustsc.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Philip Morris International’s Moira Gilchrist Positions Human Judgment as a Critical Leadership Advantage Amid Rapid AI Adoption at Wall Street Journal Forum8.5.2026 11:00:00 EEST | Press release
Philip Morris International’s (PMI) (NYSE:PM) Chief Global Communications Officer, Moira Gilchrist, joined global thought leaders at The Wall Street Journal’s Future of Everything conference in New York to examine why human cognition—judgment, context, creativity, and ethical reasoning—is becoming the most valuable asset in an age of artificial intelligence. “The AI boom is putting a premium on distinctly human capabilities,” said Gilchrist, who took part in the session “Cognition: The New Currency – Why Human Judgment Matters More Than Ever.” Speaking to attendees, she emphasized that, “As knowledge is getting democratized, human judgment, intuition, and creativity become the true differentiators that leaders need to nurture across all levels of their organizations.” Philip Morris International is today a different company, built with a singular objective: achieving a smoke-free future. It has evolved its product portfolio, reskilled its workforce, and adopted new ways of working to e
Fortegra Appoints Iwan Röpcke as Chief Executive Officer, Belgium8.5.2026 10:30:00 EEST | Press release
The Fortegra Group, Inc., a global specialty insurer, today announced the appointment of Iwan Röpcke as Chief Executive Officer, Belgium. Mr. Röpcke brings more than 25 years of insurance industry experience to the role, spanning broking, commercial leadership, and executive management across the Benelux and broader European markets. He joins Fortegra from Lloyd’s Insurance Company S.A., where he served as Country Manager for Belgium and the Netherlands, building out the operation from its early stages and overseeing both business strategy and development. Prior to Lloyd's, Mr. Röpcke held senior leadership positions at Willis Towers Watson (via Gras Savoye), where he served as Head of Sales and Head of the Competence Center. His career also includes roles at Inter Partner Assistance (AXA Assistance) as Commercial Director Benelux, Winterthur Europe Assurances, AIG Europe, Aon Belgium, and Marsh. Mr. Röpcke’s industry expertise spans a range of specialty risk areas, with deep relations
KAYTUS Launches All-QLC Flash Storage at AI EXPO 2026 for 10,000-GPU Clusters8.5.2026 10:02:00 EEST | Press release
At AI EXPO KOREA 2026, KAYTUS officially launched its All-QLC Flash Storage Solution, engineered to deliver high performance, massive scalability, and cost efficiency for 10,000-GPU clusters. The solution addresses data-delivery bottlenecks in ultra-large-scale AI training, helping maximize GPU resource utilization. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260508313130/en/ Based on the KR2280 and KR1180 server platforms, the solution is deeply integrated with industry-leading AI-native parallel file systems to eliminate data silos inherent in traditional tiered storage. Purpose-built for read-intensive AI workloads, it overcomes the horizontal scaling limitations of massive clusters. Verified test-data shows that, at exabyte-scale deployment, the solution delivers 10 TB/s aggregate bandwidth and 100 million IOPS. In addition, it reduces five-year TCO by 70% compared with traditional TLC-based solutions, accelerating mo
Beneq Appoints Dr. Jason Harrison as Chief Executive Officer8.5.2026 10:00:00 EEST | Press release
Beneq Oy, the home of atomic layer deposition (ALD), today announced the appointment of Dr. Jason Harrison as Chief Executive Officer. Dr. Harrison succeeds Dr. Tommi Vainio and will lead Beneq into its next phase of growth across semiconductor, optical, and emerging technology markets. A Strategic Leadership Transition Beneq enters its next phase of growth from a position of strong commercial momentum. Recent milestones include the qualification of the Beneq Transform® cluster tool for volume production of GaN power and RF filter devices; the introduction of Beneq Transmute™ and Beneq Transform® XP, both engineered for high-volume manufacturing (HVM) of specialty semiconductors; growing adoption of the P-Series for coating critical chamber parts in advanced node devices; and selection of the C2R™ for AR waveguide production in next-generation XR optics. Against this backdrop, the Board of Directors has determined that the time is right to align executive leadership with the company's
World Employment Confederation’s 59th Annual Conference to Address Critical Global Labour Market Concerns8.5.2026 08:12:00 EEST | Press release
Taking place on 12-13 May in Toronto and entitled ‘Grow With Talent’, this year’s World Employment Conference – co-organised with ACSESS – arrives at a time of profound economic uncertainty. This gathering of leaders and experts will help define the path forward for the global labour market and set the stage for discussions at the 114th Session of the International Labour Conference (ILC) in June. Bettina Schaller, President of World Employment Confederation (WEC) says: “The question at the heart of this year’s World Employment Conference is: how will we mobilise the world’s talent to drive growth in an era of disruption?At a time of accelerating AI adoption, rapid demographic change and an uncertain global economic outlook, pressure on labour markets is intensifying. The issue is no longer simply shortages, but how effectively talent is developed, deployed and matched to where it is needed most.” As advocates for the private employment services industry, WEC brings together policymake
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom