Telios Pharmaceuticals Inc. announced today that it has filedan investigational new drug application with the Food and DrugAdministration to begin Phase I clinical trials of its firstophthalmic product to promote healing of the cornea.
The trials will test the safety of OcuNex in healthy volunteers.More advanced trials will then test the efficacy of OcuNex intreating the corneal damage caused by severe dry eye, achronic condition that affects about 4 million peopleworldwide. Dry eye is caused by insufficient production oftears.
The privately held, San Diego-based company also plans todevelop OcuNex to treat corneal injuries and post-surgicalhealing. Telios estimates the combined market for dry eye andthese applications at more than $100 million worldwide.
OcuNex, which contains a proprietary peptide, stimulates theattachment and growth of epithelial cells in damaged areas ofthe eye's surface. The peptide forms a scaffold to which newcells attach. It also attracts growth factors that promote cellgrowth.
The same peptide is the active ingredient in Telio-Derm, whichis in advanced clinical trials to heal severe burns and chronicdermal wounds.
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