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
Revolutionizing Performance Measurement: Industry-First Methodology for Testing 5G Network Slices Enabled by Ookla and Ericsson23.2.2026 13:00:00 EET | Press release
Ookla®, a global leader in connectivity intelligence, and Ericsson, a world leader in communications technology, demonstrate an innovative solution allowing users to measure and validate 5G network slicing performance. This collaboration marks a major milestone in the 5G-Advanced era, providing a way to validate the Quality of Experience (QoE) essential for the next generation of mobile applications and use cases. Historically, measuring the performance of an individual network slice from a consumer or enterprise device has been a significant technical challenge. Traditional speed tests measure the default internet connection. Through this collaboration, Ookla and Ericsson developed a methodology that enables the Speedtest app to identify and test specific network slices. This breakthrough demonstrates how Service Level Agreements (SLAs) for differentiated services can finally be verified in real-time by both consumers using the Speedtest app and service providers. Crucially, this puts
Lenovo Unlocks Data Potential with Next Generation of AI-Driven ThinkEdge Solutions23.2.2026 13:00:00 EET | Press release
Lenovo™ expanded its ThinkEdge portfolio with a new generation of AI-driven edge computing solutions, including the compact and reliable ThinkEdge SE10n Gen 2, the AI-ready ThinkEdge SE30n Gen 2, the AI-powerhouse ThinkEdge SE60n Gen 2, and Lenovo’s first industrial all-in-one (AIO) Panel PC, the ThinkEdge SE50a. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260223166717/en/ ThinkEdge SE10n Gen 2 As enterprises push intelligence closer to operations to improve resilience, reduce latency, and keep sensitive data local, edge computing has become a critical layer between devices, infrastructure, and cloud. Lenovo’s ThinkEdge solutions are purpose-built, industrial-grade edge systems designed to run reliably in harsh, space-constrained environments where traditional servers or PCs are impractical. Powered by Intel Core processors with scalable AI options, the fanless rugged lineup features industrial design ideal for 24/7 opera
Ant Group’s Alipay AI Pay and AI Health App AQ Each Surpass 100 Million Users During CNY as AI Adoption Accelerates in China23.2.2026 11:48:00 EET | Press release
As AI adoption gained momentum during the 2026 Chinese New Year, Ant Group announced today that both Alipay AI Pay and its AI health app AQ have each surpassed the 100 million user milestone. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260223266559/en/ A Chinese consumer paying with Alipay AI payment solution while ordering coffee AI Payment Adoption Accelerates amid CNY AI Shopping Boom From ordering bubble tea and coffee to buying movie tickets, Chinese consumers embraced AI-powered services in everyday scenarios during this year’s holiday, driving a surge in Alipay AI Pay usage. Alipay AI Pay has surpassed 100 million users on February 23, becoming the world’s first AI-native payment product to reach this milestone. This surge highlights the broad commercial adoption of AI-powered payments. During the week of February 5-11, Alipay AI Pay processed over 120 million transactions. Launched in 2025, Alipay AI Pay is an inn
Australian Motoring Service Adds Support for Apple’s Roadside Assistance via Satellite through Infobip23.2.2026 11:43:00 EET | Press release
Global cloud communication platform Infobip supports Apple’s Roadside Assistance via satellite feature through Australian Motoring Service (AMS).* The groundbreaking technology enables drivers with iPhone 14 or later to request help and text with AMS — even in areas without cellular coverage — marking a significant advancement in automotive safety and customer service in Australia. According to the Australian Government, many parts of Australia’s regional and remote areas have no or poor mobile reception, which can make roadside assistance challenging. By leveraging Apple’s Roadside Assistance via satellite on Infobip's Cloud Contact Center solution, AMS provides critical support to stranded motorists in remote locations, including isolated highways, national parks, and mountainous regions. Rebecca Stenhouse, Chief Executive Officer at AMS, said: “At AMS, our priority is ensuring the safety and security of drivers across Australia. With Apple’s Roadside Assistance via satellite and Inf
AOP Health on Rare Diseases: Information. Collaboration. Innovation.23.2.2026 11:00:00 EET | Press release
Between 27 and 36 million1 people in Europe are living with a rare disease, yet only around six percent currently have access to an approved treatment2. Progress in diagnosis and treatment is often slowed by knowledge gaps, including the lack of clear, reliable, and patient-friendly information needed to support informed decision-making. Drawing on 30 years of experience in researching and developing therapies for rare diseases, AOP Health underscores the importance of collaboration across the healthcare community. On Rare Disease Day 2026, the company joins healthcare professionals, researchers and patient representatives in highlighting the need for closer cooperation to generate, share and better use scarce data to improve care for people living with rare diseases. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260223167500/en/ Rare Diseases: Collaboration is key. image: AdobeStock_1308212316 “Working in rare diseases sin
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