▎ WuXi AppTec content team editor
Recently, the international medical journal The Lancet published two articles reporting the results of important clinical trials of the blockbuster therapy facicimab for age-related macular degeneration (AMD) and diabetic macular edema (DME). These are the two main types of diseases that contribute to vision loss in adults. The results showed that Faricimab's efficacy in treating nAMD and DME was comparable to aflibercept, and the treatment interval was longer, in other words, more convenient treatment.
In a contemporaneous review article, the authors note that "these trials offer hope for the treatment of millions of patients dependent on antivascular endothelial growth factor drugs." ”
Image credit: 123RF
Age-related macular degeneration (AMD), also known as senile macular degeneration, progresses to an advanced stage called neovascular age-related macular degeneration (nAMD) or wet age-related macular degeneration (wAMD), in which neonatal and abnormal blood vessels grow uncontrollably under the macula, resulting in swelling, bleeding, and/or fibrosis, resulting in severe vision loss.
In the past decade, AMD has affected about 30% of the world's older people, mostly in people over the age of 50. Approximately 8.7% of people are blind globally, about 30 million AMD patients worldwide, and about 500,000 people are blinded by AMD every year. The prevalence of early AMD in people over 50 years of age in China is 1.7% to 9.5%, and the prevalence of advanced AMD is 0.2% to 1%.
Diabetic macular edema (DME) refers to vascular damage and leakage that occur in the central area of the retina and cause macular edema. DME is common in older people with diabetes and can lead to blindness.
At present, intravitreal injection of anti-vascular endothelial growth factor (anti‐VEGF) drugs, such as aflibercept, is the main treatment of nAMD and DME. Studies have shown that aflibercept is a humanized VEGF receptor fusion protein capable of binding to all types of VEGF-A and PGF.
Faricimab is a bispecific antibody that targets both vascular endothelial growth factor A (VEGF-A) and angiopoietin 2 (Ang-2). From a biological point of view, VEGF-A and Ang-2 signals make blood vessels unstable, induce the formation of new blood vessels and promote inflammation. Faricimab can inhibit Ang-2 signals to improve vascular stability and reduce retinal inflammation while blocking VEGF/VEGFR signals to effectively control neovascular formation.
Lancet's co-editor review article titled "Can Faricimab Reduce the Therapeutic Burden of Retinal Diseases"
(Screenshot source: The Lancet)
Treatment of nAMD
TENAYA and LUCERNE are two global Phase 3 studies of the same design in patients with neovascular age-related macular degeneration (nAMD). In both studies, 1329 patients with nAMD aged 50 years and older who received initial treatment (TENAYA study: 334 in the faricimab group and 337 in the aflibercept group; LUCERNE study: 331 in the faricimab group and 327 in the aflibercept group) were randomly assigned to receive fatimab injections every 4 months. And compare this with aflibercept's treatment regimens that take place every 8 weeks.
The results of the study showed that the treatment of faricimab showed non-inferiority in terms of visual improvement compared to patients treated with aflibercept.
In the TENAYA and LUCERNE studies, the average increase in visual acuity compared to baseline was +5.8 and +6.6 letters, respectively, in the faricimab group and +5.1 and +6.6 letters, respectively, in the aflibercept group.
Two studies also assessed the proportion of patients who received fatimabs given every 3 or 4 months during the first year. Overall, nearly 80 percent of patients in the faricimab treatment group were able to stick to the intervals of treatment every 3 months or longer during the first year.
Treatment of DME
The YOSEMITE and RHINE study, conducted in patients with diabetic macular edema (DME), evaluated 2 regimens of facimab (individualized treatment intervals [PTI], injected every 2 months, or up to every 4 months) and compared with the protocol of aflibercept injections every 2 months. Patients in the PTI group can receive facimab treatment every 1 month, 2 months, 3 months, and 4 months, adjusted according to their disease activity.
The results showed that faricimab consistently showed non-inferiority compared to aflibercept in terms of visual improvement.
In the YOSEMITE study, the mean increase in vision in the faricimab PTI group and the 2-month group was +11.6 and +10.8 letters, respectively, and +10.9 letters in the aflibercept group.
In the RHINE study, the mean increase in vision in the faricimab PTI group and the 2-month group was +10.7 and +11.8 letters, respectively, and +10.3 letters in the aflibercept group.
Two studies also assessed the proportion of patients in the Facimab PTI group who achieved a dosing plan every 3 months or every 4 months at the end of the first year. Taken together, more than 70% of patients in the faricimab PTI group were able to stick between 2 treatments for 3 months or more at the end of the first year.
Currently, faricimab has been approved by the U.S. FDA for the treatment of nAMD and DME, an innovative therapy that will bring new treatment options to millions of patients with nAMD and DME.