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Refocus Group granted go-ahead for phase 2 presbyopia trial

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DALLAS — U.S. regulators have granted approval for initiation of a phase 2 trial of Refocus Group’s scleral implants and spacing procedure for the treatment of presbyopia, according to a press release from the company.

The Food and Drug Administration’s approval is conditional on the company’s submission of additional documentation concurrent with the initiation of the clinical study, according to the release.

The phase 2 trial will be a multicenter, randomized study, with 100 patients receiving the company’s Scleral Spacing Procedure and another 50 patients designated as controls. Refocus Group has approval to begin enrollment at up to 10 sites in the United States.