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March 25, 2021

LoA Update: ReGenTree’s US approval chance for timbetasin in dry eye drops six points after Phase III miss

As of 19 March, the FDA likelihood of approval (LoA) for ReGenTree’s timbetasin acetate in dry eye disease dropped six points, according to GlobalData’s LoA data.

By Sean Rai-Roche

As of 19 March, the FDA likelihood of approval (LoA) for ReGenTree’s timbetasin acetate in dry eye disease dropped six points, according to GlobalData’s LoA data. The change is down to the company announcing that its Phase III ARISE-3 trial did not meet its primary outcome measures.

While timbetasin acetate previously had a 28% LoA, this has fallen to 22% after the topline results using GlobalData’s analysis using a combination of machine learning and its proprietary algorithm. According to an 18 March press release, timbetasin acetate did not meet its primary outcome measure of reducing corneal staining 15 days after dosing or alleviating ocular discomfort.

ARISE-3 is a randomised, quadruple-masked, placebo-controlled trial to evaluate timbetasin acetate in 700 patients with a subject reported history of dry eye for at least six months. In the trial, timbetasin acetate, a sterile eye drop, was administered four times a day for 14 days.

Sean Rai-Roche is a Reporter for Clinical Trials Arena parent company GlobalData’s investigative journalism team. A version of this article originally appeared on the Insights module of GlobalData’s Pharmaceutical Intelligence Center. To access more articles like this, visit GlobalData.

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