Oxular Ltd.

Initial safety, efficacy and durability data expected in 2H’24 OXFORD, United Kingdom & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Oxular Limited, a clinical-stage ophthalmic company developing long-lasting treatments for retinal disorders, today announces that it has begun dosing in its OXEYE Phase 2 clinical trial evaluating the company’s lead product candidate, suprachoroidal OXU-001, for the treatment of diabetic macular edema (DME). OXEYE is designed to evaluate the safety, efficacy, and durability of OXU-001 as an innovative treatment option, combining potent broad-acting anti-edema and anti-inflammatory effects with up to one-year durability for high-prevalence retinal disorders, beginning with DME. “We are thrilled to have started dosing patients with suprachoroidal OXU-001 in our OXEYE clinical trial, which will evaluate the potential for once-a-year treatment by leveraging our Oxusphere™ sustained-release technology. OXEYE builds on the positive clinical experience to date with our Oxulumis® illuminated microcatheter for in-clinic posterior suprachoroidal delivery,” said Dr. Friedrich Asmus, MD, Chief Medical Officer of Oxular. “This marks Oxular’s most significant milestone to date and brings us closer to our goal of developing safe and highly effective treatments to reduce the treatment burden for patients and retinal specialists. We look forward to clinical data from the OXEYE trial next year.” OXU-001 is dexamethasone formulated in a novel biodegradable drug preparation known as Oxuspheres™. OXU-001 is optimized for delivery to the posterior suprachoroidal space of the eye via Oxulumis®, Oxular’s proprietary illuminated microcatheter. This in-office treatment enables routine access closer to the ocular tissues with high disease activity, which could lead to enhanced efficacy, favorable tolerability, and extended durability of up to one-year. The OXEYE trial is a two-part, randomized Phase 2 trial in patients with DME that is designed to evaluate a single administration of suprachoroidal OXU-001 over 52 weeks. Part A of the trial is expected to randomize 18 patients in the U.S. who have been previously treated with anti-VEGF therapy to one of two dose levels of OXU-001. Gated by interim read-outs from Part A, Part B will be a masked evaluation of 110 DME patients who have either been previously treated with anti-VEGF therapy or are treatment-naïve, randomized to one of the two dose levels of OXU-001 or Ozurdex® (dexamethasone intravitreal implant). Primary endpoints at Week 24 are safety and efficacy, and patients will continue to be monitored monthly for 52 weeks. “Today’s standard-of-care treatments for DME require frequent injections, which create adherence challenges resulting in suboptimal vision outcomes for many patients,” stated Dr. Anat Loewenstein, MD, Director of the Department of Ophthalmology at the Tel Aviv Medical Center. “It is very exciting that we will soon see patient data of suprachoroidal OXU-001, a potential treatment option with the goal of one treatment a year.” Oxular expects to report 24-week data from Part A, including safety and durability, in the second half of 2024. About Oxular Oxular is a biotechnology company developing safe, long-lasting suprachoroidal retinal treatments to improve patients’ vision so they can live better lives. The company has engineered its sustained-release drug formulations to last up to one year following single dosing and delivery technology to access tissues in the posterior suprachoroidal space via a routine, in-office administration. This unique combination aims to improve patients’ vision by increasing therapeutic effectiveness, while reducing side-effects and minimizing the frequency of treatments.

OXFORD, United Kingdom & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Oxular Limited, a clinical-stage ophthalmic company developing long-lasting targeted treatments for retinal disorders to improve patients’ vision, today announces that Mark Gaffney has been appointed as chief executive officer (CEO) and member of the Board of Directors. Mr. Gaffney succeeds Thomas Cavanagh, who has transitioned from his role as CEO role to pursue other opportunities. “This is an exciting time of clinical development at Oxular, the only clinical-stage company that is posteriorly delivering sustained-release therapies to the back of the eye, which should allow for fewer injections and a favorable safety pro with current treatment options,” said Mr. Gaffney. “I’ve seen first-hand what the challenges and burdens from retina diseases and progressive vision loss can have on a person and their loved ones. I am deeply committed to Oxular’s mission and look forward to collaborating with the leadership team and Board to maximize the full potential of Oxular’s pipeline.” “On behalf of the Board, we are thrilled to benefit from Mark’s extensive experience as we advance to the next phase of growth,” said David Fellows, chair of Oxular’s Board of Directors. “We want to thank Tom for his many contributions in evolving Oxular to this point. As we transition to mid-stage development with our programs and look to optimize the application of our technologies, Mark’s background in business development, operations and finance will be invaluable. The retina continues to be an exciting target for innovation, and we are confident in Mark’s ability to advance our lead asset for diabetic macular edema, OXU-001, to market.” Mark Gaffney brings over 20 years of biotech leadership experience to Oxular. He previously served as chief business officer and chief operating officer at Vedere Bio, a private ophthalmic-focused gene therapy company, where he oversaw business development, finance, legal, human resources, program management, information technology and facilities. Mr. Gaffney was part of the team that led the sale of Vedere’s original lead program to Novartis in 2020 for up to $280 million. Prior to Vedere, he served as head of external innovation and corporate development at Cyclerion Therapeutics, and he held multiple leadership roles at Ironwood Pharmaceuticals, Inc., including head of corporate development and deputy general counsel. Mr. Gaffney also served for five years as an intelligence officer in the United States Air Force. Mr. Gaffney holds a Bachelor of Science in mechanical engineering from the University of Pennsylvania and a juris doctor degree from Boston University. About Oxular Oxular Limited 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. For more information, please visit oxular.com.

OXU-001 represents potential best-in-class treatment for DME with just one, targeted administration per year Initiation of OXEYE Phase 2 clinical trial of OXU-001 in DME patients on-track for first quarter of 2023; Initial clinical data on safety and durability expected in 2023 OXFORD, United Kingdom--(BUSINESS WIRE)-- 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.