OXULAR-LIMITED
24.1.2023 14:01:39 CET | 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/
About Business Wire
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
New Pipistrel Voyager Brings Next Generation Training Capabilities and Access to Flight Schools20.7.2026 15:00:00 CEST | Press release
Debuting at EAA AirVenture 2026 in Oshkosh, the world’s largest aviation gathering Pipistrel, a Textron Inc. (NYSE: TXT) company and an affiliate of Textron Aviation Inc., today introduced the Pipistrel Voyager, a next-generation training aircraft designed to expand capability for flight schools while maintaining the efficiency and simplicity owners and operators expect from Pipistrel. Purpose-built for evolving pilot training requirements, the Voyager is designed to align with anticipated Modernization of Special Airworthiness Certification (MOSAIC) regulations. This positions the aircraft to support broader training missions while improving access to pilot development. The aircraft is expected to enter into service in 2027. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260720673571/en/ New Pipistrel Voyager brings next generation training capabilities and access to flight schools (Photo Credit: Pipistrel, a Textron Inc. c
86% Of Enterprises Have Deployed AI Agents. Just 34% Trust Them, Boomi Study Finds.20.7.2026 15:00:00 CEST | Press release
Boomi-commissioned independent study finds integration, not smarter models, separates enterprises that trust their AI agents from those stuck in “agentic chaos” Boomi, the data activation company for AI, today announced new research conducted by Forrester Consulting on behalf of Boomi showing that despite rapid enterprise adoption of AI agents, trust hasn't kept pace with ambition. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260720652115/en/ Boomi-commissioned independent study finds integration, not smarter models, separates enterprises that trust their AI agents from those stuck in “agentic chaos” The Forrester survey of 409 director-and-above IT and technology decision-makers across North America, Europe, and APAC found that 86% of organizations have moved beyond the AI agent pilot stage, yet just 34% say they trust the actions their AI agents are taking. Among organizations in a state of "agentic chaos" (the bottom qu
Expensify Launches Corporate Card in Europe20.7.2026 15:00:00 CEST | Press release
Finance teams across the UK and EU can now issue Expensify Visa® Commercial Cards for real-time spend visibility, built-in policy controls, and fewer reimbursements. Expensify, Inc. (Nasdaq: EXFY), the easiest way to manage expenses, corporate cards, and travel, today announced that the Expensify Card is available to businesses of all sizes in the UK and select European markets, including Spain, Ireland, Poland, and the Netherlands. “The Expensify Card works quietly in the background to keep your business spend controlled, compliant, and ready for accounting,” said David Barrett, founder and CEO of Expensify. “It’s a preaccounting assistant that eliminates hours of reconciling transactions, chasing receipts, and reimbursing employees. One of our US customers, Pivot Bio, cut down on their expense report audit times by 90%. We can’t wait to share that same time savings with millions of businesses in the UK and EU.” Key benefits of the Expensify Card include: Real-time spend visibility: T
HistoSonics Opens Expanded Histotripsy Training Center in Hong Kong20.7.2026 14:00:00 CEST | Press release
HistoSonics today announced the opening of its expanded Histotripsy Training Center in Hong Kong, reinforcing the city's position as a leading hub for physician education, clinical collaboration, and innovation in Asia. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260720812810/en/ Pictured at the expanded Histotripsy Training Center in Hong Kong. Front row (left to right): Dr. Angus Yuen, Chief Medical Officer, Gleneagles Hospital Hong Kong; Prof. Albert Chan, Director of Liver Cancer Surgery Centre, Gleneagles Hospital Hong Kong; Dr. Kenneth Tsang, Regional Chief Executive Officer, IHH Healthcare North Asia, and Chief Executive Officer, Gleneagles Hospital Hong Kong; Dr. Vince Lau, Director of Interventional Radiology Centre, Gleneagles Hospital Hong Kong; Dr. Joe Herman, Vice President, Medical Affairs, HistoSonics. Back row (left to right): Jay Lee, APAC Regional Manager, HistoSonics; Eric Kwong, Hong Kong Sales Manager
Shaping a Generation Through Dialogue: Inside the Doha Debates Ambassador Program20.7.2026 13:29:00 CEST | Press release
Applications are open for young people from around the world to learn to engage and lead through truth-seeking conversations about complex global issues In a world shaped by change and competing narratives, the ability to listen, question and engage in constructive dialogue has never been more critical. Through the Doha Debates Ambassador Program, a production of Qatar Foundation, young people from around the world are not only learning these skills, but actively applying them in their communities, careers and areas of study. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260720452437/en/ Shaping a Generation Through Dialogue: Inside the Doha Debates Ambassador Program. Applications are open for young people from around the world to learn to engage and lead through truth-seeking conversations about complex global issues. (Photo: AETOSWire) This online educational program teaches young people from across the globe to debate d
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