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 Phase III Double-Blind, Parallel Group, Multicenter Study to Compare the Efficacy and Safety of Xlucane Versus Lucentis in Patients With Neovascular Age-Related Macular Degeneration

Next Previous
Trial Profile

A Phase III Double-Blind, Parallel Group, Multicenter Study to Compare the Efficacy and Safety of Xlucane Versus Lucentis in Patients With Neovascular Age-Related Macular Degeneration

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 15 Nov 2023

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 Ranibizumab (Primary)
  • Indications Choroidal neovascularisation; Wet age-related macular degeneration
  • Focus Adverse reactions; Pharmacokinetics; Registrational; Therapeutic Use
  • Acronyms XPLORE
  • Sponsors Xbrane

    • Most Recent Events

    • 01 Sep 2023 According to Xbrane media release, company announced that STADA and Xbrane had agreed to discontinue the commercial licensing agreement for North America with their former partner.
    • 21 Jun 2023 According to Xbrane media release, the supplemental Biologics License Application (sBLA) for a Lucentis (ranibizumab) biosimilar has been accepted by the US Food and Drug Administration (FDA). The FDA filing is supported by a comprehensive Comparative Analytical Assessment of the biosimilar candidate vs. Lucentis (ranibizumab) and positive data from this trial. The regulatory process can be initiated with a Biosimilar User Fee Amendment (BsUFA) goal date of April 21st, 2024.
    • 31 May 2023 According to Xbrane media release, the company has submitted biologics license application (BLA) for Ximluci to the US Food & Drug Administration, FDA, Within 60 days, the FDA is expected to validate and decide on reviewing the application. The company expects a review process of around 10 months and approval in the first half of 2024.
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
Legal
Back to top