SeaBeLife announces preclinical efficacy results for SBL03 topical ophthalmic gel

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The gel addresses necrotic retinal cell death in dry age-related macular degeneration and geographic atrophy without requiring injections

An elderly woman undergoes an eye exam. Image credit: ©kasto – stock.adobe.com

SeaBeLife said the company plans to begin regulatory preclinical studies in 2025. Image credit: ©kasto – stock.adobe.com

SeaBeLife, a biotechnology company based in France, announced in vivo results for its drug candidate SBL03, a topical ophthalmic gel designed to combat necrotic retinal cell death in dry age-related macular degeneration (AMD) and geographic atrophy (GA). The preclinical study aimed to evaluate the efficacy and tolerability of SBL03 in a model of induced retinal degeneration, according to a press release from SeaBeLife.

The therapeutic candidate SBL03 is a dual inhibitor of regulated necrotic cell death, formulated as an ophthalmic gel for non-invasive, topical delivery. It was evaluated using an animal model reproducing the key clinical characteristics of geographic atrophy seen in patients, including degeneration of the retinal pigment epithelium. The gel is designed to prevent sight loss associated with retinal degeneration by targeting the photoreceptor cells responsible for sight which are impacted by retinal disease.

According to SeaBeLife, the study findings highlight the ability of SBL03 to infiltrate the eye and reach its target retinal tissue in adequate concentration.The therapeutic effects were evaluated using functional and structural analysis in vivo, including electroretinography, optical coherence tomography and fundus autofluorescence. The researchers also performed post-mortem quantitative histological testing. Analysis of the results demonstrated that eyes treated with SBL03 showed significant protection of the structural and functional integrity of the retina. Repeated topical ocular treatment with SBL03 demonstrated a protective effect against retinal degeneration when compared with a placebo.

Jean-François Korobelnik, professor of ophthalmology at the Bordeaux University Hospital, France, was quoted in the press release from SeaBeLife. “The preclinical results achieved with SBL03 are highly promising and open up new opportunities in the treatment of degenerative retinal disorders,” he said. “The combination of targeted action and topical delivery makes it a particularly promising solution for preserving patients’ sight and therefore their quality of life.”

Morgane Rousselot, PhD, CEO and co-founder of SeaBeLife, addressed the position of SBL03 in the broader market of therapeutics for AMD and GA. “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. 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.”

SeaBeLife said the company plans to ramp up development of SBL03 by introducing a standard production process and begin regulatory preclinical studies in 2025. SeaBeLife aims to conduct an initial clinical trial in humans in 2026.

Reference

Dry AMD: SeaBeLife achieves highly promising preclinical efficacy results for SBL03, without injections into eye. Andrew Lloyd & Associates. Press release. Published 29 January, 2025. Accessed 30 January, 2025. https://ala.associates/clinical/dry-amd-seabelife-achieves-highly-promising-preclinical-efficacy-results-for-sbl03-without-injections-into-eye/
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