Squalamine eye drops granted fast track designation in the US for wet AMD

Source: BioSpace
Area: News
According to BioSpace, squalamine eye drops have been granted Fast Track designation by the US FDA for the potential treatment of the wet form of age-related macular degeneration (wet AMD).   Squalamine is s small molecule inhibitor of multiple growth factors implicated in angiogenesis, including Vascular Endothelial Growth Factor (VEGF) and Platelet Derived Growth Factor (PDGF); the latter has recently been identified as an additional key target for the treatment of wet AMD.  An intravenous formulation of squalamine has been found in Phase I and II testing maintain or improved visual acuity outcomes in wet-AMD, with both early and advanced lesions responding.  A novel eye drop formulation has now been developed, and preclinical testing has demonstrated that it is safe to ocular tissues and achieves in excess of target anti-angiogenic concentrations in the tissues of the back of the eye.  The Company anticipate commencing a Squalamine Eye Drop phase II ...