Ophthalmic Gel Shows Promising Results for Geographic Atrophy Treatment
French biotech, SeaBeLife, has announced promising preclinical trial results for its drug candidate, SBL03, an ophthalmic gel aimed at treating geographic atrophy (GA), a severe form of age-related macular degeneration (dry AMD). The gel - a dual inhibitor of regulated necrotic cell death - demonstrated significant protection of retinal structure and function after repeated topical applications.
SeaBeLife plans to continue development with regulatory preclinical studies this year, with aims to begin human trials in 2026. With geographic atrophy affecting millions of people worldwide, the non-invasive treatment could offer a more comfortable alternative to current injections, which are used in the U.S. but not available in Europe and could become a breakthrough treatment for this leading cause of blindness in those over 50.
SeaBeLife, a biotechnology company developing innova- tive drug candidates intended to block cellular necrosis, today announces significant in vivo results for its SBL03 drug candidate, an innovative ophthalmic gel to combat necrotic retinal cell death in geographic atrophy (GA), an advanced form of dry AMD (age-related macular degeneration). These data can be regarded as a major step forward on a high-stakes journey to provide a solution for the millions of patients faced with irreversible sight loss, for whom there is no available treatment in Europe.
The primary aim of the study was to evaluate the efficacy of the SBL03 drug candidate in an in vivo preclinical model of induced retinal degeneration. It involved confirming the therapeutic potential of SBL03 in the treatment of geographic atrophy, a severe form of age-related macular degeneration (dry AMD) using a groundbreaking, non-invasive, well-tolerated solution.
SBL03 is a dual inhibitor of regulated necrotic cell death. It is formulated as an ophthalmic gel for topical delivery in the form of eyedrops and is therefore non-invasive. This solution would prevent patients from experiencing sight loss associated with retinal degeneration, by directly targeting the cells affected by the disease, whatever its origin.
The efficacy of SBL03, an ophthalmic gel formulation, was evaluated using a preclinical animal model reproducing the key clinical characteristics of geographic atrophy seen in patients. These include degeneration of the retinal pigment epithelium, resulting in progressive, irreversible loss of the photoreceptor cells responsible for sight.
After retinal degeneration was induced, the preclinical models were treated with repeated topical instillations of SBL03 over several days. The therapeutic effects were evaluated using functional and structural analysis in vivo (electroretinography – ERG; optical coherence tomography – OCT; fundus autofluorescence – FAF), along with post mortem quantitative histological testing.
The data highlights the ability of SBL03 to infiltrate the different parts of the eye and reach its target tissue, the retina, in adequate concentration. Analysis found that the SBL03-treated eyes show significant protection of the structural and functional integrity of the retina. The various parameters examined were correlated and show that repeated topical ocular treatment with SBL03 has a protective effect against retinal degeneration compared with placebo.
“The preclinical results achieved with SBL03 are highly promising and open up new opportunities in the treatment of degenerative retinal disorders. The combination of targeted action and topical delivery makes it a particularly promising solution for preserving patients’ sight and therefore their quality of life,” said Prof. Jean-François Korobelnik, professor of ophthalmology at the Bordeaux University Hospital, France.
“Compared with current treatments, available only in the US, including intravitreal injections, the topical method of delivery used for SBL03 could considerably improve patient comfort and adherence for this chronic disorder, which requires life-long treatment. It would provide a
promising alternative that could transform the care of patients who currently lack a satisfactory or well-tolerated treatment option,” said Morgane Rousselot, PhD, CEO and co-founder of SeaBeLife. “With the series A funding round that we’re preparing for at the moment, we will be able to continue the development of SBL03 in treating this disorder which affects millions of people worldwide.”
To date, SeaBeLife is the only company to develop a therapeutic solution with topical delivery that contains a regulated necrotic cell death inhibitor to treat geographic atrophy. This positions SBL03 as a breakthrough innovation. SeaBeLife plans to ramp up the development of SBL03 by introducing a standard production process. Regulatory preclinical studies are expected to start in 2025, with the aim of conducting an initial clinical trial in humans in 2026.
Geographic atrophy is a severe, advanced form of dry (or atrophic) AMD which is characterized by progressive, irreversible sight loss. The disorder results from the destruction of the photoreceptors and the cells in the retinal pigment epithelium; it affects five million people worldwide. Owing to population aging, this figure is expected to reach ten million by 2040. In both Europe and the United States, it is the leading cause of blindness in patients aged over 50. Currently, there is no medication or treatment available in Europe for dry AMD.
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