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April 19, 2021

LoA Update: Ortho Dermatologics’ FDA approval potential for its acne gel jumps 12 points after Phase III meets primary endpoint

Ortho Dermatologics’ topical gel IDP-120 for moderate-to-severe acne vulgaris saw a 12-point increase in its Likelihood of Approval (LoA) due to its Phase III trial meeting its primary endpoint.

By Reynald Castañeda

Ortho Dermatologics’ topical gel IDP-120 for moderate-to-severe acne vulgaris saw a 12-point increase in its Likelihood of Approval (LoA) due to its Phase III trial meeting its primary endpoint. The 608-patient Phase III has a primary endpoint investigating inflammatory lesion count reduction. Specifically, it is further defined as superiority in absolute change versus a vehicle control from baseline to week 12.

IDP-120 previously had a 46% LoA, which jumped to 58%, as of 12 April, according to GlobalData analysis that uses a combination of machine learning and a proprietary algorithm. While it’s been announced the trial has been completed, more data is yet to be revealed. The Phase III update was revealed in a quarterly report by Bausch Health (NYSE:BHC), the parent company of Ortho Dermatologics, covering the period ending 30 September 2020, which was filed to the SEC on 11 November 2020.

IDP-120 features a fixed-dose combination of benzoyl peroxide and tretinoin. On a 3 March call at the JPMorgan Global High Yield & Leveraged Finance Conference, Bausch Health Chief Financial Officer Paul Herendeen said it is exploring next steps for IDP-120.

Reynald Castaneda is an Associate Editor 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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