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Lpath submits investigational new drug application of retinal disease drug
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SAN DIEGO — Lpath has filed an investigational new drug application with the U.S. Food and Drug Administration to conduct a phase 1 trial evaluating the efficacy of a drug for treating wet age-related macular degeneration, the company announced in a press release.
The drug, called iSONEP, is the ocular formulation of sonepcizumab, a humanized monoclonal sphingosine-1-phosphate antibody that has shown anti-angiogenic, anti-inflammatory, anti-vascular permeability and anti-fibrosis mechanisms of action in ocular models of retinal diseases — including diabetic retinopathy, dry AMD, uveitis, glaucoma-related surgery and proliferative retinopathy, according to the release.
"Results of Lpath's ocular discovery program suggest that iSONEP may be a valuable therapeutic in the treatment of diabetic retinopathy, dry AMD and uveitis, and in the prevention of scar formation associated with many glaucoma-related surgeries. These disorders, besides representing significant market potential, also represent significant unmet medical needs at the present time," said Roger A. Sabbadini, Lpath's founder and chief scientific officer.
Lpath expects to commence the phase 1 study in the third quarter of 2008, the release said.