- Swiss pharma Roche over the weekend reported positive Phase 2 results for its experimental eye drug faricimab, opening up the possibility of less frequent injections for people with wet age-related macular degeneration.
- In a year-long STAIRWAY study, patients given faricimab injections every three or four months (depending on disease activity) showed similar or better improvements in vision compared with monthly injections of Lucentis, according to results presented at the 2018 American Academy of Ophthalmology’s annual meeting in Chicago. Roche now plans to launch a Phase 3 study of faricimab in wet AMD.
- The pharma also presented data from the LADDER study on the combination of its Port Delivery System and ranibizumab, the active drug in Lucentis. This refillable implant supports dosing intervals of six months or longer, with data showing similar outcomes to four-weekly injections. The pivotal Phase 3 Archway trial and the Portal label extension study began in September 2018.
Many of the existing injectable treatments for wet age-related macular degeneration (AMD), including Lucentis (ranibizumab), target and inhibit vascular endothelial growth factor-A (VEGF-A).
One of the challenges of the current anti-VEGF monotherapies for wet AMD is the burden of frequent clinic visits, as often as every four weeks. While Lucentis was developed by Genentech, a member of the Roche Group, and licensed to Novartis outside of the U.S., both companies are developing competitors in wet AMD.
Around 11 million people in the U.S. have some form of AMD, and 10% have wet AMD, which is the more severe form. Wet AMD is one of the leading causes of blindness in the U.S. in people 60 and over.
Genentech’s faricimab is a bispecific antibody, and according to the company, it is the first such antibody developed for injection in the eye that binds to and neutralizes both angiopoietin-2 and VEGF-A. The STAIRWAY data suggest faricimab could support fewer injections with the same visual gains seen with once-monthly Lucentis, a current standard of care.
This weekend, Novartis released two-year results for its single chain antibody fragment, brolucizumab, which also targets VEGF-A. Results showed the drug to be non-inferior to Regeneron’s Eylea (aflibercept) in terms of visual acuity at year one and year two in patients with neovascular AMD, and superior in retinal outcomes at year one and year two. Many of the patients studied were able to continue with brolucizumab on a quarterly dosing schedule.
Regeneron isn’t going to go down without defending its top seller, despite the challenge it is facing over approval of the Eylea pre-filled syringe. The company plans to roll out a direct-to-consumer campaign for Eylea before the end of the year.
Roche and Genentech also have two Phase 3 trials, RHINE and YOSEMITE, open and enrolling for faricimab. These will assess the monoclonal antibody in people with diabetic macular edema (DME), in comparison with Eylea (aflibercept).