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Recently, Roche-controlled Chugai Pharmaceutical Co.
Diabetic macular edema (DME) is a complication of diabetic retinopathy (DR), which can severely cause blindness
Neovascular age-related macular degeneration (nAMD), also called wet age-related macular degeneration, is one of the main types of age-related macular degeneration (AMD), accounting for 15% to 20% of all AMD patients, affecting approximately the world 20 million people are the main cause of blindness among people aged 60 and above
Faricimab is a bispecific antibody designed for the eye
The new drug application is based on the YOSEMITE and RHINE studies carried out in DME patients, and the TENAYA and LUCERNE studies carried out in nAMD patients
YOSEMITE and RHINE are two identical randomized, multi-center, double-blind global phase III studies, enrolling a total of 1891 DME patients (940 YOSEMITE and 951 RHINE)
In December 2020, Roche announced that the two studies of YOSEMITE and RHINE reached the primary endpoint: compared with the aflibercept (q8w) group, the two groups of patients treated with faricimab showed non-inferior visual benefits
TENAYA and LUCERNE are also two identical randomized, multi-center, double-blind global phase III studies, enrolling a total of 1,329 nAMD patients (TENAYA 671 and LUCERNE 658).
In January 2021, Roche announced that the two studies of TENAYA and LUCERNE had reached the primary endpoints
In terms of safety, faricimab was well tolerated in the above four studies, and no new safety signals appeared
As the first bispecific antibody against ophthalmic diseases reported for production, faricimab is expected to occupy a place in the ophthalmology field with its excellent efficacy and long dosing interval in the future
Anti-VEGF drugs are currently the first-line drugs for fundus vascular diseases such as DME and nAMD.
In addition to the above-mentioned faricimab, which is a dual-target ophthalmic drug, Rongchang Bio and Innovent have also developed dual-target drugs RC28-E and IBI-302 for ophthalmic diseases
