Australia latest to approve Bayer's Eylea

8 March 2012

The Australian Therapeutic Goods Administration (TGA) has approved Eylea (aflibercept) Injection for the treatment of patients with neovascular (wet) age-related macular degeneration (wet AMD). The drug will be marketed by Germany-based Bayer (BAY: DE), which licensed it from US firm Regeneron Pharmaceuticals (Nasdaq: REGN). Bayer Healthcare plans to launch Eylea in Australia in the second half 2012.

The TGA approval of Eylea is based on the results of two positive Phase III clinical studies (VIEW 1 and VIEW 2) which demonstrated that the drug dosed every other month, following three initial monthly injections, was non-inferior to Lucentis (ranibizumab injection) dosed every four weeks, as measured by the primary endpoint of maintenance of visual acuity (less than 15 letters of vision loss on an eye chart) over 52 weeks. The most common adverse reactions (frequency of 5% or more) reported in patients receiving Eylea were conjunctival hemorrhage, cataract, eye pain, vitreous detachment, vitreous floaters and increased intraocular pressure.

Approval and registration status

This article is accessible to registered users, to continue reading please register for free.  A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Login to your account

Become a subscriber

 

£820

Or £77 per month

Subscribe Now
  • Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
  • Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
  • Daily roundup of key events in pharma and biotech.
  • Monthly in-depth briefings on Boardroom appointments and M&A news.
  • Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK



Companies featured in this story

More ones to watch >


Today's issue

Company Spotlight





More Features in Pharmaceutical