Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

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-1

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-1

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 20 May 2021

Price : $35 *
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

  • Drugs Timbetasin (Primary)
  • Indications Dry eyes
  • Focus Registrational; Therapeutic Use
  • Acronyms ARISE-1
  • Sponsors ReGenTree
  • Most Recent Events

    • 13 May 2021 According to a ReGenTree Media Release, based on recent reclassification of RGN-259 to a Biologics License Application and the draft guidance for dry eye from the FDA, the company has started discussions with regulatory consulting firms to explore the prospects of a pre-BLA meeting with the FDA using these comprehensive data from ARISE-1, ARISE-2, and ARISE-3 studies. The company will proceed with a request for a pre-BLA meeting and future development steps will depend on the discussion results.
    • 13 May 2021 Pooled results from ARISE-1, ARISE-2, and ARISE-3 studies published in the ReGenTree Media Release.
    • 18 Mar 2021 According to a RegeneRx Biopharmaceuticals media release, the company look forward to completing the analyses, reporting results, and meeting with the FDA as soon as practicable.
Subscriber content

You need to be a logged in subscriber to view this content.

If your organization has a subscription then there are several options available to help you access AdisInsight, even while working remotely.

  • IP authentication when working within your organization’s network.
  • with username/password or try via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days.
  • Contact us at AsktheExpert.AdisInsight@springer.com for assistance.

If your organization does not have a subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Buy a PDF version of the profile.
  • Request a free trial
Back to top