Trial Profile

A Multi-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Safety and Efficacy of RGN-259 Ophthalmic Solutions for the Treatment of Dry Eye (ARISE-3)

Status: Completed

Phase of Trial: Phase III

Latest Information Update: 18 May 2022

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At a glance

02 May 2022 Status changed from active, no longer recruiting to completed.
02 Mar 2022 According to a ReGenTree Media Release, the pre-BLA (Biologics License Application) meeting was held by the Office of New Drugs/Office of Specialty Medicine in CDER and the Department of Ophthalmology/Office of Specialty Medicine, including specialists from statistics, safety, pharmacology, CMC, GCP and RA at FDA on 28 Feb 2022 to discuss a potential BLA submission for RGN-259 for dry eye syndrome.
15 Sep 2021 Planned End Date changed from 30 Apr 2021 to 30 Dec 2021.

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