France-based SeaBeLife and Unither Pharmaceuticals are collaborating on the development and manufacturing of clinical and commercial batches of an investigational topical ophthalmic formulation for retinal degenerative disorders.
Chief among these retinal targets: geographic atrophy (GA) and dry age-related macular degeneration.
First, a look at these players.
We’ll begin with Unither Pharma.
With locations across Brazil, China, and the United States (in Rochester, New York), Unither operates as a contract development and manufacturing organization (CDMO) of pharmaceutical products.
At its U.S. location: The pharmaceutical laboratory is responsible for developing liquid formulations (sterile single doses, especially) for pharma companies producing phase 1-3 products, generics, over-the-counter (OTC) medications, branded products, and medical devices.
- See here for a look at its technologies, services, and other innovations.
And SeaBeLife?
Founded in 2019, the biotechnology company is developing small molecules that simultaneously target two regulated cell death pathways: necroptosis and ferroptosis (and notably not the all-too-commonly-targeted complement pathway).
- Take note: These forms of regulated necrosis can cause inflammation and oxidative stress, contributing to an associated disease.
The intent: To block cellular necrosis and address major unmet medical needs in acute, rare, and chronic indications that can be impacted.
- Examples of these: Dry AMD and chronic hepatitis—the focus of SeaBeLife’s two flagship programs.
Explain the science and technology behind these programs.
Based on a bespoke technological platform, the company’s small molecules are designed to simultaneously fight those aforementioned forms of regulated necrosis and, as a result, protect organs under attack.
The clinical evidence of this: Is reportedly based on the molecules’ performance in both in vitro and in vivo models conducted among mouse models of hepatotoxicity, renal failure, and ocular pathologies, according to SeaBeLife.
- We’ll get to more data later on …
And which molecule will this partnership be focusing on?
That would be SBL03, formulated as an ophthalmic gel for non-invasive topical (eye drop) delivery to target retinal cell necrosis in GA and dry AMD.
More about it: The asset is a dual inhibitor of regulated necrotic cell death that blocks the cellular necrosis pathways involved in retinal degeneration—effectively infiltrating eye tissues and protecting the retina from degeneration.
- The intended result: To prevent patients from experiencing vision loss associated with retinal degeneration.
So what’s the plan for its development?
The purpose behind SeaBeLife and Unither’s joint development agreement is to accelerate the pharmaceutical and regulatory preclinical development of SBL03 prior to the launch of clinical trials.
- To note: These trials are expected to kick off in 2027.
Per the companies, the partnership covers:
- Development and industry scale-up of SBL03
- Manufacturing of preclinical and Good Manufacturing Practices (GMP) batches
- Analytical development
- Preparation of the Chemicals, Manufacturing, and Controls (CMC) application or submission to regulatory authorities to begin phase 1 clinical trials
And what roles will each company have?
While SeaBeLife is expected to retain ownership, Unither will be responsible for the "pharmaceutical development and manufacture of preclinical batches” of SBL03.
Collectively: “The agreement provides for joint work on testing the formulation and process development to start immediately, as well as the setup of a shared steering committee to monitor progress and collectively approve major milestones.”
Nice! Now let’s circle back to that pre-clinical data you mentioned earlier.
Ah yes. SeaBeLife reported those in vivo findings in January 2025.
The purpose behind this research: To evaluate the efficacy of SBL03 in an in vivo animal model of induced retinal degeneration—including confirming its potential for treating GA.
The research itself: Involved repeated topical doses of SBL03 over several days, with its therapeutic effects analyzed via functional and structural analysis (see here for specifics)
What was determined?
Investigators found that the SBL03-treated animal eyes showed significant protection of the structural and functional integrity of the retina, according to the company.
Further: “The various parameters examined were correlated and (demonstrated) that repeated topical ocular treatment with SBL03 has a protective effect against retinal degeneration compared with placebo,” SeaBeLife stated.
And the potential?
With intravitreal injections, the current standard of care for retinal degeneration treatment, SBL03’s topical delivery represents a promising alternative therapy.
Stay tuned for updates on its clinical journey!