Sandoz to begin Phase III trial of aflibercept biosimilar

Goodwin
Contact

Goodwin

On May 3, 2021, Sandoz announced that it will begin enrolling patients in MYLIGHT, a clinical Phase III confirmatory efficacy and safety study for its proposed biosimilar to Regeneron’s EYLEA (aflibercept) product.  EYLEA is indicated for neovascular age-related macular degeneration (nAMD), diabetic macular oedema, macular oedema secondary to retinal vein occlusion, and other neovascular retinal diseases.

MYLIGHT is a randomized, double-blind, parallel 2-arm trial with a projected enrollment of 460 patients with nAMD in 20 countries.  Patients with nAMD will be randomized to receive either the biosimilar candidate or EYLEA for 48 weeks.  The mean change in best corrected visual acuity score from baseline to week 8 will serve as the primary end point.  The study aims to confirm that the biosimilar candidate has equivalent efficacy and comparable safety to EYLEA in patients with nAMD.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Goodwin | Attorney Advertising

Written by:

Goodwin
Contact
more
less

Goodwin on:

Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
- hide
- hide

This website uses cookies to improve user experience, track anonymous site usage, store authorization tokens and permit sharing on social media networks. By continuing to browse this website you accept the use of cookies. Click here to read more about how we use cookies.