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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
Original Article: FDA requires third phase 3 trial of dry eye treatment candidate RGN-259NEXT ARTICLE
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