Regeneron Pharmaceuticals, Inc. has reportedly acquired the United Kingdom-based Oxular, a biotechnology company specializing in developing sustained-release formulations for retinal disease.
Though there’s been no official word confirming this, the news was announced by Regeneron CEO Mark Gaffney via a Jan. 2 LinkedIn post.
First, what do we know about this deal?
Aside from Gaffney’s social media announcement, no further details have been released on this acquisition. In fact, neither company has commented on the news.
Take note: Glance reached out to Regeneron for comment; as of 2 pm EST on Jan. 6, the company has not yet responded.
So let’s get a rundown on Oxular.
Launched in 2014 and headquartered in Oxford, England, the biotech company’s product pipeline is based on technologies “designed to provide retinal specialists with innovative treatment approaches, to solve serious and persistent issues facing retinal patients,” according to Oxular.
These technologies include:
- Oxuspheres
- What it is: A proprietary, drug-containing, biodegradable polymer system
- Its purpose: To deliver clinically therapeutic drug levels over prescribed treatment periods to target tissues involved in retinal disorders
- Simultaneously: This system is intended to maintain low drug levels elsewhere in the eye—minimizing off-target drug side effects
- See here for its key features and benefits
- Simultaneously: This system is intended to maintain low drug levels elsewhere in the eye—minimizing off-target drug side effects
- Oxulumis
- What it is: A minimally-invasive, semi-automated administrated device
- Its purpose: To routinely deliver therapeutics via an illuminated microcatheter to the posterior suprachoroidal space within the eye.
- See here for its key features and benefits.
And the potential for these technologies?
With oxuspheres, Oxular has noted that drug products incorporating this tech could ”provide sustained drug treatments and have the potential to address significant unmet needs.”
- How: by improving patient outcomes and dramatically reducing the unsustainably high treatment burden for patients, retinal specialists, and healthcare systems.
And with oxulumis, the minimally-invasive, in-office procedure uses a small-gauge needle insertion to deliver drugs only after visual confirmation of the correct microcatheter placement (via semi-automated deployment) to ensure accurate drug delivery.
Among its intended results:
- Safe and routine drug administration
- No need to penetrate the intraocular space
- Products are delivered alongside the posterior retina and macula
So what’s in the company’s pipeline?
Included in Regeneron’s purchase of Oxular is the biotech’s lead investigational candidate: OXU-001—which has already made clinical advancements with the FDA.
What it is: A sustained-release dexamethasone formulation consisting of oxuspheres.
- In relation to this therapeutic: The microspheres are posited to deliver a precision daily dose of the medication to the target retinal and choroidal tissues via Oxular’s Oxulumis technology.
And what indications is OXU-OO1 under clinical development for?
Three key retinal diseases:
- Diabetic macular edema (DME)
- Retinal vein occlusion (RVO)
- Uveitis
Let’s talk clinical data. Anything to note yet?
Indeed there is. OXU-001 has undergone clinical investigation in 12-month preclinical trials for its DME indication.
The findings from those: Oxular reported OXU-001 to be well tolerated, with pharmacokinetic data for the drug establishing its levels to be consistently maintained in target retinal tissues.
- Plus: Low drug levels were present in off-target tissues related to steroid side effects, such as the vitreous and lens.
And what did that suggest?
When reporting this preclinical data, the company stated that the data suggests “a single treatment of OXU-001 “may provide up to 12-month treatment effects with an improved clinical safety profile.”
The in-office treatment was also noted for its potential to lead to “enhanced efficacy, favorable tolerability, and extended durability to address key unmet needs for people with DME and other retinal disorders.”
How does this compare to current DME treatment?
Standard treatment approaches typically involved limited durability and frequent anti-vascular endothelial growth factor (VEGF) injections into the eye, noted former Oxular CEO Thomas Cavanagh in 2023.
Case in point: Abbvie’s OZURDEX (dexamethasone intravitreal implant) 0.7 mg, a popular treatment on the market indicated for DME as well as RVO and posterior uveitis, usually requires more than two implants per year.
“The opportunity to provide patients with a targeted, in-office treatment just once a year could be a game-changer for this prevalent disease,” Cavanagh previously stated.
Anything else?
As a result of that preclinical data, the FDA accepted Oxular’s investigational new drug (IND) application for suprachoroidal OXU-001 to treat DME (back in January 2023 … see our coverage).
As a bonus: The FDA’s acceptance enabled the company to move forward with its phase 2 OXEYE trial, designed to further assess OXU-001’s safety and efficacy for treating DME.
Nice! So what do we know about this trial?
The two-part, randomized phase 2 study (NCT05697809) began patient dosing (of DME participants) in October 2023.
Its purpose: To evaluate a single administration of suprachoroidal OXU-001 over a 52-week period.
Its design:
- Part A: Randomization of 18 participants in the U.S. who were previously treated with anti-VEGF therapy to one of two dose levels of OXU-001
- Part B: Masked evaluation of 110 DME patients—previously treated with anti-VEGF therapy or are treatment-naïve—randomized to one of two dose levels of OXU-001 or OXURDEX
And what’s being measured?
Evaluated at Week 24, the primary endpoints include safety and efficacy.
To note: Patients will continue monitoring on a monthly basis for 52 weeks.
And when can we expect data?
While the company initially stated clinical data would be released in 2024, no results have been posted as of yet. Per Clinical Trials, the study’s estimated completion date is March 2025.
And in the meantime, let’s hope we hear some official word from Regeneron and/or Oxular on next steps for this acquisition.