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ACT gets approval to initiate phase 1/2 study for treatment of myopia

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Advanced Cell Technology Inc. and the University of California, Los Angeles, have received approval from the U.S. Food and Drug Administration to initiate a phase 1/2 study using ACT’s retinal pigment epithelial cells derived from human embryonic stem cells to treat myopia, according to a company press release.

The primary focus of the study will be to evaluate the safety in patients with severe myopia of the type that causes fissures in the retinal pigment epithelium (RPE) layer of the eye, the release said.

The trial is a prospective, open-label study designed to determine the safety and tolerability of human embryonic stem cells-derived RPE cells following subretinal transplantation into patients with myopia at 12 months, according to the release.