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Ohr Pharmaceutical wins fast track designation for wet AMD product candidate

Monday, May 14 2012 | Comments
Evidence Grade 0 What's This?
The Food and Drug Administration granted Ohr Pharmaceutical Inc.'s squalamine eye drops fast track status for the treatment of wet age-related macular degeneration (AMD).

Squalamine inhibits vascular endothelial growth factor and other angiogenic growth factors, such as platelet-derived growth factor, which Ohr said has been identified as an additional key target for the treatment of wet AMD. The compound is expected to enter Phase II testing in the third quarter.

Ohr recently presented findings from a biodistribution and safety study of its squalamine eye drops at the 2012 annual meeting of the Association for Research in Vision and Ophthalmology. Trial data indicated the "potential therapeutic value of the squalamine eye drop program in treating wet AMD and ophthalmic neovascular disorders," according to Ohr.

Irach Taraporewala, Ohr's chief executive officer, said squalamine eye drops could provide "tremendous benefit" to patients who use Genentech Inc.'s Lucentis (ranibizumab) or Regeneron Pharmaceuticals Inc.'s Eylea (aflibercept), both of which are administered via intravitreal injection.

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