ADC Reviews

EU approves marketing application of ophthalmic dual antibody Faricimab


On September 19, Roche announced that the marketing application of the ophthalmic dual anti-Faricimab (Vabysmo) has been approved by the European Union for the treatment of neovascular or wet age-related macular degeneration (nAMD) and diabetic macular edema (DME). Faricimab is currently the only injectable ophthalmic drug approved in Europe.

Faricimab is the first VEGF-A/ANG-2 bispecific antibody developed for ophthalmic disease. Compared with anti-VEGF therapy alone, the use of Faricimab dry to treat a variety of retinal diseases can reduce the frequency of ocular injections and improve long-term visual outcomes in patients.

Faricimab can reduce the frequency of dosing because it can simultaneously target two different signaling pathways, vascular endothelial growth factor A (VEGF-A) and angiopoietin 2 (Ang-2). Biologically, VEGF-A and Ang-2 signaling destabilize blood vessels, induce neovascularization and promote inflammation. While blocking VEGF/VEGFR signaling to effectively control neovascularization, Faricimab can also inhibit Ang-2 signaling to improve vascular stability and reduce retinal inflammation.

The approval is based on the results of four Phase III studies in two indications, enrolling a total of 3,220 patients. TENAYA and LUCERNE are one-year studies for nAMD, while YOSEMITE and RHINE are two-year studies for DME. These studies showed that patients in the faricimab arm achieved similar improvements in visual acuity and retinal anatomy compared with aflibercept given every 2 months. Two-year data from all four studies showed that more than 60% of patients in the faricimab arm were able to extend treatment cycles to every 4 months while improving and maintaining vision. In addition, over two years, the median number of injections in the nAMD and DME patients treated with faricimab was 33% and 21% less, respectively, than in the aflibercept group.

Overall, the safety and tolerability of faricimab was good, and the most common adverse reactions (≥3%) included cataract, conjunctival hemorrhage, vitreous floaters, increased intraocular pressure and eye pain.

On January 28 this year, the FDA approved Faricimab for the treatment of wet age-related macular degeneration and diabetic macular edema. On March 28, Japan’s PMDA approved the listing of Faricimab.

Aflibercept (VEGFR-Fc fusion protein) is the standard therapy for nAMD. Recently, two phase III studies of aflibercept were successful, extending the dosing cycle from once every 2 months to once every 4 months. Beovu (brolucizumab) developed by Novartis is a single-chain antibody fragment that can achieve higher molar dosing. It is the first anti-VEGF therapy for nAMD that requires only one injection every 3 months. Sales in the first half of 2022 are $54 million. Faricimab’s sales in the first half of this year have reached 109 million Swiss francs, and it is expected to be comparable to the first two in its first year of listing.

Wet age-related macular degeneration (AMD), an eye disease that affects people’s daily activities that require clear central vision, such as reading, progresses to an advanced stage called neovascular age-related macular degeneration (nAMD) , or wet age-related macular degeneration (wAMD), is a pathology characterized by the uncontrolled growth of new and abnormal blood vessels under the macula, causing swelling, bleeding and/or fibrosis, causing rapid and severe vision loss.

Diabetic macular edema (DME) is a complication of diabetic retinopathy (DR). In diabetic patients, due to excessive blood sugar, the blood vessels in the eye are damaged, which will lead to the infiltration of blood and/or body fluids into the retina, which will lead to the occurrence of DR, which manifests as swelling and blockage of blood supply in some areas of the retina. If blood vessel damage and leakage occurs in the central area of ​​the retina, it can cause macular edema, known as diabetic macular edema. If left untreated, DME can seriously threaten vision and affect quality of life. There are currently approximately 21 million DME patients worldwide. As the number of diabetic patients increases, the number of DME patients is expected to increase, and more effective and longer-acting treatment options other than anti-VEGF are needed.