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FDA requires third phase 3 trial of dry eye treatment candidate RGN-259

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The FDA has accepted all safety data from two phase 3 trials of dry eye treatment candidate RGN-259, but it is requiring an additional phase 3 trial to further demonstrate efficacy, RegeneRx Biopharmaceuticals announced in a press release.

Chemistry and manufacturing control plans for RGN-259 are acceptable for submission of a new drug application, and ReGenTree will begin the third phase 3 trial, ARISE-3, this year, Won Yan, president and CEO of ReGenTree, said in the release.

ReGenTree is a joint venture company, owned by RegeneRx and GtreeBNT, that is developing RGN-259 in the United States and Canada. In 2015, it licensed the rights for RGN-259 from RegeneRx.

“We are pleased that we are moving forward with development of RGN-259 for dry eye and that our partner has effectively completed the comprehensive and expensive ancillary work required for an NDA, including the numerous toxicology, stability and manufacturing studies required to bring a new drug to the market,” J.J. Finkelstein, president and CEO of RegeneRx, said in the release.