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
Airship Announces 2026 Elevate Customer Experience Award Winners4.5.2026 16:00:00 EEST | Press release
Airship, the mobile-first customer experience company, today announced the winners of the 2026 Elevate Customer Experience Awards. Global brand leaders from The Economist, Southwest Airlines, and OneFootball were among those honored at the Elevate’26 Customer Experience Summit. The Elevate Awards spotlight global companies that have developed exceptional mobile-first customer experiences for their customers, created innovative campaigns, leveraged AI agents to reach new levels of productivity, and achieved real business results. "Evolving mobile-first consumer behaviors and unprecedented advancements in AI are driving a seismic shift that is reshaping how brands interact with their customers," said Brett Caine, CEO, Airship. "The 2026 Elevate Award winners aren’t just adapting, they’re leading transformative and meaningful customer experiences. These leading organizations are turning everyday interactions into seamless, cross-channel journeys that deliver meaningful business impact and
Tigo Energy Breaks Global Growth Benchmark; Boosts U.S. Energy Feature in Predict+4.5.2026 16:00:00 EEST | Press release
Tigo Energy, Inc. (NASDAQ: TYGO) (“Tigo” or “Company”), a leading provider of intelligent solar and energy solutions, today announced that the Predict+ platform now offers integrated real-time spot market pricing for ISO customers in the United States. Predict+ provides utilities with deep insights into grid demand, renewable generation, and energy market dynamics, enhancing the precision, scalability, and robustness of energy forecasting to up to 97.5% accuracy through machine learning and artificial intelligence. For energy providers, Predict+ helps streamline operations, reduce volatility, and maximize performance. Predict+ empowers utility operators to adapt to real-world demand challenges when balancing renewable and baseload generation sources, particularly during extreme weather events and market disruptions. On the demand side, with smart meter integration, Predict+ models each meter individually and performs extensive calculations on actual, historical, and average data to acc
Alnylam to Present New Analyses at Heart Failure 2026 Underscoring Consistent Clinical Profile of Vutrisiran in ATTR-CM4.5.2026 15:30:00 EEST | Press release
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced it will present new data analyses for vutrisiran in patients with the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) at Heart Failure 2026, a scientific congress of the European Society of Cardiology, taking place May 9-12, 2026, in Barcelona, Spain. ATTR-CM is a heterogeneous and rapidly progressive disease, and patients often present with complex clinical profiles. At Heart Failure 2026, Alnylam will present multiple new analyses from the Phase 3 HELIOS-B study of vutrisiran, which continue to support its use as a first-line treatment for patients with ATTR-CM, and further characterize its clinical profile across patients with a high disease burden, and in the context of concomitant therapies. Vutrisiran is the first and only transthyretin (TTR) silencer for ATTR-CM that delivers rapid knockdown of TTR at the source. Additional analyses being pr
Takeda Announces Positive Topline Results from Pivotal Phase 2/3 Clinical Trial of TAK-881 in Primary Immunodeficiency Disease (PID)4.5.2026 15:00:00 EEST | Press release
Takeda (TSE:4502/NYSE:TAK) today announced that TAK-881-3001, a pivotal Phase 2/3 clinical trial in patients with Primary Immunodeficiency Disease (PID), met its primary endpoint, which demonstrated pharmacokinetic (PK) comparability between the investigational TAK-881 [Immune Globulin Subcutaneous (Human), 20% Solution (SCIG 20%) with Recombinant Human Hyaluronidase] and HYQVIA [Immune Globulin Infusion (Human) 10% with Recombinant Human Hyaluronidase]. Additionally, secondary endpoints showed that TAK-881, a SCIG 20% facilitated with hyaluronidase, demonstrated safety, efficacy and tolerability profiles comparable to HYQVIA, an established SCIG 10% facilitated with hyaluronidase. These findings support the potential of TAK-881 to deliver the required immunoglobulin (IG) dose for PID patients in half the volume of HYQVIA, reducing infusion duration while maintaining flexible, up to once-monthly dosing for patients (every three or four weeks for PID). The TAK-881-3001 clinical trial ev
Ouster Releases The REV8 OS Family: The World’s First Native Color Lidar4.5.2026 13:00:00 EEST | Press release
Ouster, Inc. (Nasdaq: OUST) (“Ouster” or the “Company”), a leader in sensing and perception for Physical AI, announced today its new family of OS digital lidar sensors, Rev8, powered by its next-generation L4 Ouster Silicon. Ouster Rev8 features the world’s first patented native color lidar sensors, provides up to double the range and resolution of the previous generation, and is designed for functional safety, reliability, affordability, and scale. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260504718668/en/ The REV8 OS Family: The World's First Native Color Lidar. L4 Ouster Silicon: Ouster’s breakthrough L4 architecture doubles the range and resolution of its lidar over the prior generation, adds native-color sensing, and is designed for functional safety. Based on patented Ouster Silicon with embedded Fujifilm color science, the L4 chip results in exquisite color data and hardware-enabled HDR. It boasts 42.9 GMACs of p
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