Topical ESBA105 Demonstrates Efficacy in the Back of the Eye to Inhibit Neovascularization

26-Mar-2009 - Switzerland
ESBATech AG announced preclinical results, which demonstrate efficacy of topical ESBA105, an anti-Tumor Necrosis Factor (TNF) single-chain antibody fragment, in a model for choroidal neovascularization (CNV). In wet age-related macular degeneration (wet AMD), CNV causes the formation of new blood vessels growing behind the retina, which can lead to bleeding, scarring and sight loss in patients. Anti-Vascular Endothelial Growth Factor (VEGF) therapies are successfully used in AMD; however, only 30-40% of patients benefit from an anti-VEGF therapy with improvement in visual acuity. ESBATech's results confirm that CNV is not exclusively driven by VEGF, but also by inflammatory mediators such as TNF alpha. Findings from this study show that ESBA105, when applied as eye drops, can significantly reduce CNV. The preclinical study was designed to evaluate the pathophysiological relevance of TNF, and the effect of topical ESBA105 in a primate model for CNV and compare its efficacy against an intravitreal injection of the marketed TNF antagonist, Humira® and VEGF antagonist, Avastin®, which have both shown efficacy in this model. The model selected for this study measures severity of lesions in the macula, which are generated by photocoagulation using a laser. The surrogate injury model for AMD has been proven successful in predicting therapies that are efficacious like Lucentis® in the treatment of AMD. David Urech, Ph.D., Head of Research and Development of ESBATech commented on the preclinical results, "These results confirm our previous pharmacokinetic studies, showing that topical ESBA105 efficiently migrates to the posterior or the back segments of the eye, and leads to therapeutically effective concentrations even in the retina. In addition, our results suggest that TNF alpha plays an important role in a variety of ocular neovascular disorders." ESBATech continues to progress clinical candidates in ophthalmology with a series of studies relating to the treatment of inflammatory ocular diseases. In February 2009, ESBATech initiated a Phase Ia/IIb study for cataract surgery and a Phase IIa trial for acute anterior uveitis. Earlier this year, ESBATech initiated a Phase I/IIa study to explore clinical activity of ESBA105 in osteoarthritis of the knee.

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