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
Tax Systems Rebrands as Alphatax16.7.2026 10:00:00 CEST | Press release
New brand unveiled at Tax Tech Live 2026 as company sets out AI-powered vision to become the trusted intelligence powering modern tax Tax Systems, a global tax and accounting software provider, today announced it is rebranding as Alphatax, aligning the company with its flagship corporation tax compliance solution and marking the next stage in its evolution as an AI-first technology business. The rebrand reflects the company's ambition to redefine how tax professionals work through connected, AI-powered technology. As Alphatax, the business is bringing together compliance, data, governance and intelligence into a single platform, creating the foundations for the world’s first tax operating system: a connected environment where tax data, decisions, approvals, filings and evidence can come together. The new identity builds on the strong reputation of Alphatax, a market-leading corporation tax software trusted by tax professionals across the world. Bringing the company’s expanding portfoli
SWISSto12 Closes US$70 Million Series C to Meet Growing Multi-Orbit Demand16.7.2026 09:00:00 CEST | Press release
Swiss satellite and payload manufacturer announces close of Series C on the back of 110% CAGR since 2022 and a total of more than $500 million in contracted orders. SWISSto12, a leading enabler of the new space economy, today announced the close of its $70 million (€61 million) Series C. This news follows the award of $84.8 million (€73 million) from European Space Agency (ESA) Member States to the HummingSat ARTES partnership project, through which ESA supports SWISSto12 in the development and in-orbit validation of HummingSat. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260716342732/en/ SWISSto12 will scale its manufacturing and integration capacity to meet accelerating demand from commercial and sovereign government customers. The Series C fundraise follows a period of sustained commercial growth for the company, with revenues of $140 million (€121 million) for 2025 and total contract values now exceeding $500 million
AMINA Becomes the First Regulated Bank to Integrate Leading Crypto Payments Network, Mesh16.7.2026 08:30:00 CEST | Press release
With connectivity across 300+ providers, Mesh’s verified deposit technology eliminates friction from digital asset deposits for AMINA clients AMINA Bank AG (“AMINA”), a Swiss Financial Market Supervisory Authority (FINMA)-regulated crypto bank with global reach, today becomes the first regulated bank to integrate Mesh, the leading crypto payments network. The integration embeds Mesh’s verified deposit technology directly into AMINA’s online banking platform. This allows clients to verify wallet ownership, and deposit stablecoins and digital assets in a single, streamlined flow across more than 300 wallet providers. No more copying wallet addresses by hand, switching between external tools, or completing the multi-step verification the process historically required. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260715917516/en/ AMINA is the first regulated bank on Mesh. Myles Harrison, Chief Product Officer at AMINA, said: “
Garvan Institute of Medical Research Joins Parse Biosciences’ Certified Service Provider Network15.7.2026 22:00:00 CEST | Press release
Researchers across Asia-Pacific gain a new option for high-quality single cell sequencing through Garvan's Evercode WT services Parse Biosciences, a QIAGEN company, and the leader in scalable and accessible single cell sequencing, today announced that the Genomics Platform Core Facility within the Garvan Institute of Medical Research has joined its Certified Service Provider (CSP) Program. The partnership broadens access to high-quality, scalable single cell sequencing across Australia, the wider Asia-Pacific region, and beyond. Garvan is one of Australia's preeminent medical research institutions, with the Genomics Platform having deep experience in cell sorting, capture, and sequencing. As a Certified Service Provider, Garvan will offer Parse's Evercode WT kits to researchers across the region. "We see a growing number of requests for Parse projects and find the technology easy to implement and run, generating great data," said Chris O'Keeffe, Cellular Genomics Lead at the Garvan Ins
Grafana Labs Named a Leader in 2026 Gartner® Magic Quadrant™ for Observability Platforms and Positioned Furthest in Completeness of Vision15.7.2026 20:21:00 CEST | Press release
Named a Leader for the third consecutive year and placed furthest in vision for the second year in a row, the company has had a landmark year of innovation as observability becomes essential infrastructure for teams building and running AI at scale. Grafana Labs, the company behind the open observability cloud, today announced it has been named a Leader in the Gartner® Magic Quadrant™ for Observability Platforms for the third consecutive year, and positioned furthest on the Completeness of Vision axis for the second year running. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260715814984/en/ 2026 Gartner® Magic Quadrant™ for Observability Platforms We believe this placement reflects where the market is headed: toward open, composable observability that helps teams in the AI era understand systems that are increasingly complex and agentic, and rapidly scaling thanks to AI-assisted engineering. A Platform Built for the AI Era
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