Announcement on the First Trial Data of DURAVYU™ for Wet Age-Related Macular Degeneration from Partner EyePoint
The Company and all members of the Board of Directors guarantee that the information disclosed is true, accurate, and complete, and that there are no false records, misleading statements, or material omissions.
Today, BeiGene Ltd. ("Company") partner EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT, "EyePoint") announced data from the first trial, LUGANO, of two pivotal Phase III clinical trials for its investigational ophthalmic formulation EYP-1901, a vitreal implant (DURAVYU™), for the treatment of wet age-related macular degeneration ("wAMD"). EyePoint is a specialty pharmaceutical company dedicated to developing and commercializing innovative therapeutic solutions for ocular diseases. In February 2020, Equinox Sciences, LLC, a wholly-owned subsidiary of the Company, exclusively licensed EyePoint to develop the vitreal implant for the treatment of wAMD and other ophthalmic diseases in regions outside of China.
The LUGANO study is a Phase III, randomized, double-masked, active-controlled clinical study designed to evaluate the efficacy and safety of DURAVYU 2.7mg administered once every 6 months compared to Eylea 2mg administered once every 8 weeks for the treatment of wAMD. The primary endpoint is the non-inferiority of the mean change in best-corrected visual acuity (BCVA) from baseline at Week 52 and Week 56.