US FDA Requires RegeneRx to Conduct Third Phase III Trial for Dry Eye Candidate RGN-259

April 13, 2018: By Jon Swedien

The US FDA will require a third Phase III clinical trial for RegeneRx Biopharmaceuticals’ dry eye candidate before the agency will consider approving its new drug application, the Rockville, Maryland, company reported April 9.

The additional Phase III trial is needed for RGN-259 to further demonstrate efficacy in both signs and symptoms of dry eye in a larger patient population, RegeneRx said.

RegeneRx licensed the US rights to RGN-259 to ReGenTree—a joint venture between GtreeBNT and RegeneRx. RegeneRx retains full ownership of the intellectual property related to RGN-259 in the European Union.

ReGenTree plans to start a new trial, ARISE-3, this year, said President and CEO Won Yang.

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