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
NIQ and Similarweb Advance Agentic Commerce Measurement for the AI Shopping Era2.9.2026 12:45:00 CEST | Press release
New solution will connect AI-driven discovery to consumer intent, product content, AI-driven traffic and sales conversion NIQ (NYSE: NIQ), a leading consumer intelligence company, today announced further advancements in its Agentic Commerce Measurement strategy through a collaboration with Similarweb (NYSE: SMWB). The companies are collaborating on a new solution to help brands, retailers and technology platforms understand how products are purchased in an increasingly agentic economy. The work adds a measurement component to NIQ's Commerce Intelligence strategy, focused on deploying NIQ’s world-class, AI-ready content directly into agentic commerce workflows and equipping brands and retailers with the signals they need to react effectively. AI agents are moving beyond product discovery to become part of the purchase itself. New infrastructure, including Google's Universal Commerce Protocol and OpenAI's Agentic Commerce Protocol, is enabling consumers to complete the entire buying jour
MEX Exchange, part of MultiBank Group, Strengthens Global Operations and Technology Leadership with Three Senior Promotions2.9.2026 12:38:00 CEST | Press release
Jeremy Pearce and Beth White promoted to regional COO roles, with James Longo named CTO MEX Exchange, the institutional electronic trading platform of MultiBank Group, has announced three senior promotions as it strengthens its operational and technology leadership to support the continued development and international growth of its institutional trading business. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260902298207/en/ Jeremy Pearce has been promoted to COO – Middle East, Africa & Asia, Beth White to COO – Americas & Europe, and James Longo to Chief Technology Officer (CTO). Jeremy Pearce has been promoted to COO – Middle East, Africa & Asia, Beth White to COO – Americas & Europe, and James Longo to Chief Technology Officer (CTO). The appointments establish dedicated operational leadership across MEX Exchange’s key international markets, supported by experienced technology leadership as the company continues to devel
Compass Pathways Recognized as a 2026 Fierce 50 Breakthrough Honoree2.9.2026 12:30:00 CEST | Press release
Compass Pathways, a biotechnology company dedicated to unlocking urgently needed new treatment options in mental health care, has been named a 2026 Fierce 50 Breakthrough honoree by Fierce Pharma, Fierce Biotech and Fierce Healthcare. The Fierce 50 recognizes 50 individuals and organizations driving advancements in medicine, fostering innovation and shaping the future of biopharma and healthcare. Compass is leading a profound shift in the development of new treatment options in mental health care – moving beyond daily or frequent administration toward an option that could potentially provide durable efficacy with just a few treatments a year that could be life changing for patients. Supported by robust clinical data from three late-stage trials involving more than 1,000 participants living with treatment-resistant depression (TRD), COMP360 psilocybin, if approved by the U.S. Food & Drug Administration (FDA), has the potential to establish a new standard of care for a condition affectin
Exeon Analytics expands management team for next growth phase2.9.2026 10:00:00 CEST | Press release
Exeon Analytics is expanding its management team with two new roles. Wayne Jennings takes on the newly created position of Chief Solutions Officer, and Johan Roman becomes Chief Revenue Officer. The appointments fall in the company’s anniversary year, ten years after its founding as an ETH Zurich spin-off, and create the structure for the next growth phase. Exeon Analytics delivers holistic security analytics for organizations facing growing blind spots, encrypted traffic and regulatory pressure. Wayne Jennings joined Exeon Analytics in July 2024 and initially led Support and Engineering. As Chief Solutions Officer, he is responsible for the technical customer lifecycle, from pre-sales and proof of concept through implementation to long-term technical account management, and for the technical enablement of partners. Before joining Exeon Analytics, he was a Senior Manager in Cybersecurity & Privacy at PwC Switzerland, focusing on threat intelligence and incident response. Johan Roman br
euroAtlantic Airways Expands Long-Haul Fleet With a New Airbus A330-300 Aircraft2.9.2026 09:00:00 CEST | Press release
euroAtlantic Airways (“EAA”), a Njord Partners portfolio company and a leading Portuguese aircraft wet-leasing and charter business, is pleased to announce the induction of a new Airbus A330-300 aircraft into its fleet, further strengthening its long-haul widebody capabilities and reinforcing the Company's growth trajectory in the ACMI and charter markets. The Airbus A330-300 is leased from Jackson Square Aviation (JSA). Only 15 years old, the aircraft is configured in a three-class layout of Business, Premium Economy and Economy, accommodating a total of 290 passengers, and features full lie-flat seating in Business Class along with personal in-seat entertainment monitors fitted across the entire cabin. The aircraft, which will be registered as CS-TGI after completing its normal process of approval with authorities, has already completed its delivery journey, departing Kuala Lumpur (KUL) and arriving into Beja, Portugal (BYJ) on 17 August 2026. This aircraft type is known for its effi
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