BioTime, Inc. (BTX) and its subsidiary Cell Cure Neurosciences Ltd. today announced that the U.S. Food and Drug Administration has granted Fast Track designation for OpRegen.
OpRegen is a cell-based therapeutic product consisting of retinal pigment epithelial cells designed to block the progression of the severe dry-form of age-related macular degeneration, a leading cause of blindness in an aging population.
Cell Cure is now enrolling patients at Hadassah University Medical Center in Jerusalem, Israel, in a clinical Phase I/IIa dose-escalation study evaluating the safety and efficacy of OpRegen for geographic atrophy, the severe stage of the dry form of age-related macular degeneration.
The first patient was treated earlier this year and Cell Cure expects to provide interim data in early 2016.
The FDA grants Fast Track designation if it determines that a drug fills an unmet medical need in a serious condition.
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