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
Fuji Electric Joins Helical Fusion as Strategic Investor and Official Partner as Series B Second Close Raises JPY 3.23 Billion8.10.2026 02:00:00 CEST | Press release
Major Japanese industrial players join Helical Fusion as construction of Helix HARUKA advances through a public-private partnership spanning government, national research infrastructure, and Japan’s manufacturing sector Helical Fusion Co., Ltd., a fusion energy company developing a Helical Stellarator with the goal of achieving commercially viable fusion power in the 2030s, today announced the completion of a JPY 3.23 billion (approximately USD 20.6 million) Series B second close. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261007813917/en/ Helical Fusion and new investors for the Series B 2nd close The round marks another expansion of the industrial coalition forming around Helical Fusion’s Helix Program. Fuji Electric Co., Ltd., one of Japan’s major electrical and industrial equipment manufacturers, has joined Helical Fusion as both an investor and an Official Partner of the Helix Program. Other new investors in the sec
New INRIX Parking Scorecard Reveals Cities with the Most Parking, Highest Prices, and Lowest Availability7.10.2026 22:16:00 CEST | Press release
The Scorecard analyzes more than 120 downtown areas across North America and Europe, comparing parking availability, prices and curb use policies INRIX, a leader in transportation analytics and mobility intelligence, today released its first-ever INRIX Parking Scorecard, the largest comparative analyses of downtown parking conditions across North America and Europe. Drawing on parking availability, curb regulations, pricing data and parking infrastructure from more than 120 downtown areas in 14 countries, the report reveals significant differences in parking conditions and how cities allocate curb space. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261007322796/en/ New INRIX Parking Scorecard: Where Downtown Parking Costs Most The Scorecard examines parking availability: the probability of finding a parking space alongside on-street and off-street parking pricing, and curb use policies. The findings show that parking condi
Lattice Collaborates with Arm to Advance Secure, Adaptable AI Data Center Infrastructure7.10.2026 22:00:00 CEST | Press release
Lattice Semiconductor (NASDAQ: LSCC), the low power programmable and platform firmware leader, today announced a collaboration with Arm to enable secure control, management, and platform adaptability for AI infrastructure. Combining Arm® AGI CPU server platforms with Lattice FPGAs and AMI firmware creates a solution that provides advanced security, manageability, connectivity, and flexibility for next-generation AI data center infrastructure. In Arm AGI CPU server platforms, Lattice FPGAs work alongside the CPU and baseboard management controller, with AMI firmware providing platform boot and management capabilities. The Lattice FPGAs act as companion chips providing secure control and management capabilities, enabling platform trust, connectivity, and infrastructure adaptability. Lattice FPGA technology also enables Open Compute Project (OCP)-compliant connectivity between the Host Processor Module (HPM) and Datacenter Secure Control Module (DC-SCM) through the LVDS Tunneling Protocol
Bentley Systems Announces Winners of the 2026 Year in Infrastructure Awards7.10.2026 19:55:00 CEST | Press release
New cycle of AI-enabled innovation is helping engineers solve harder problems faster (The Bentley Systems 2026 Year in Infrastructure Event) – Bentley Systems, Incorporated (Nasdaq: BSY), the infrastructure engineering software company, today announced the winners of the 2026 Year in Infrastructure Awards. For more than 20 years, the awards have honored the extraordinary work of infrastructure professionals and their innovative use of Bentley software to improve how infrastructure is designed, built, and operated. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261007964087/en/ Bentley Systems announced the winners of the 2026 Year in Infrastructure Awards on October 7, 2026 (Photo courtesy of Bentley Systems) In 2026, over 300 projects were nominated by organizations in 53 countries. Winners were selected across 12 categories spanning the infrastructure lifecycle, industries, and disciplines by a panel of independent judges
Day One Strategy Founders Recognised in The LDC Top 50 Most Ambitious Business Leaders for 20267.10.2026 19:00:00 CEST | Press release
Hannah Mann and Abigail Stuart, Co-Founders of Day One Strategy have been recognised as one of The LDC Top 50 Most Ambitious Business Leaders for 2026. The programme was created by private equity investor LDC, part of Lloyds Banking Group, in partnership with The Times. Since 2018, it has celebrated the ambition and achievements of hundreds of exceptional entrepreneurs. This year The LDC Top 50 attracted more than 620 nominations from across the UK, highlighting the depth of ambition among leaders building successful businesses in every region and sector. The leaders featured are driven by an appetite for growth that is helping to build stronger, more sustainable businesses and a more competitive UK economy. They are expanding internationally, developing new products and services, challenging established markets and investing in their people. Together, their businesses generate £1.4bn in annual revenues and employ almost 8,500 people. Headquartered in 55 towns and cities, they demonstr
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