Regeneron Pharmaceuticals has acquired UK-based company Oxular Limited, the biotech firm behind therapeutic candidate OXU-001. The news was first reported by Fierce Biotech1 following a LinkedIn post by Oxular’s former CEO and board member Mark Gaffney2 and has not been confirmed in a press release by Regeneron or Oxular.
According to his LinkedIn profile, Gaffney served as the CEO of Oxular from September 2023 to June 2024, when he shifted into a strategic advisor position. Gaffney’s profile notes that he also served as a board member for the duration of his tenure there, which ended upon Oxular’s acquisition in December 2024.
“I am happy to report that Oxular has been acquired by Regeneron,” Gaffney wrote in an early-January announcement.2 “The ophthalmology team at Regeneron is uniquely positioned to maximize the use of Oxular’s proprietary technologies.”
The Oxular portfolio includes the therapeutic candidate, OXU-001, as well as the proprietary suprachoroidal microcatheter delivery device, Oxulumis. On the product page3 Oxular describes OXU-001 as a broad-acting anti-inflammatory for the treatment of diabetic macular edema (DME), retinal vein occlusion (RVO) and uveitis. The dexamethasone-containing Oxuspheres are designed for delivery by the Oxulumis system to the posterior suprachoroidal area, in a once-per-year routine delivery. Past and current trials indicate up to 12-month durability, sustained vision gain and retinal thickness reduction, according to Oxular.
In an email to Fierce Biotech, a Regeneron spokesperson confirmed that, while some Oxular employees are “helping short-term with tech transfer and transition work in consulting roles,” the employees will not join Regeneron going forward.1 The spokesperson also reportedly told Fierce Biotech that more information on the acquisition will become available at the time of Regeneron’s next quarterly filing.
In October 2024, Oxular announced that it began dosing patients in its OXEYE phase 2 clinical trial, evaluating the safety, efficacy and durability of OXU-001 in patients with DMO. The two-part, randomized OXEYE trail is designed to evaluate a single suprachoroidal administration of OXU-001 over 52 weeks. In a press release from October 20244, Oxular said that in Part A, 18 patients in the US who had already been treated with anti-VEGF therapy would be randomized to one of two dose levels of OXU-001. In Part B, gated by interim readouts from Part A, 110 patients with DME who had been previously treated with anti-VEGF therapy or were treatment-naïve would be randomized to one of two dose levels of OXU-001 or a dexamethasone intravitreal implant (Ozurdex) in a masked evaluation. In Part B, patients will be monitored for 52 weeks, with safety and efficacy as primary endpoints for week 24.
Ophthalmology Times Europe has reached out to Regeneron for comment.
References
-
Masson G. Regeneron acquires UK biotech, adding Oxular’s eye disease delivery tech to portfolio. Fierce Biotech. Published January 2, 2025. Accessed January 6, 2025. https://www.fiercebiotech.com/biotech/regeneron-acquires-uk-biotech-adding-oxulars-eye-disease-delivery-tech-portfolio
-
Gaffney M. I am happy to report that Oxular has been acquired by Regeneron. The ophthalmology team at Regeneron is uniquely positioned[…] LinkedIn. Published January 2, 2025. Accessed January 6, 2025. https://www.linkedin.com/posts/mark-gaffney-b97a7812b_i-am-happy-to-report-that-oxular-has-been-activity-7280624147506892801-iOOB/
-
OXU-001. Oxular. Accessed January 6, 2025. https://oxular.com/oxu-001/
-
Oxular Doses First Patients in OXEYE Phase 2 Clinical Trial of Suprachoroidal OXU-001 as a Long-Acting Treatment for Diabetic Macular Edema. Oxular Limited. Press release. Published October 24, 2024. Accessed January 6, 2025. https://www.businesswire.com/news/home/20231024987114/en/Oxular-Doses-First-Patients-in-OXEYE-Phase-2-Clinical-Trial-of-Suprachoroidal-OXU-001-as-a-Long-Acting-Treatment-for-Diabetic-Macular-Edema%22
Leave a Reply