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Faricimab (genetical recombination), also known as FARICIMAB-SVOA, is a bispecific antibody that targets both Angiopoietin-2 (Ang2) and Vascular Endothelial Growth Factor A (VEGF-A). It is the first-in-class bi-specific antibody that can simultaneously inhibit both Ang2 and VEGF-A pathways, making it a promising drug for the treatment of various eye diseases. This article aims to provide an in-depth analysis of Faricimab, including its mechanism of action, therapeutic areas, active and inactive indications, and approval timeline.
Mechanism of Action
Faricimab works by blocking the actions of both Ang2 and VEGF-A, which are known to contribute to the development of various eye diseases. Ang2 is a protein that plays a crucial role in the formation of new blood vessels, while VEGF-A is a growth factor that stimulates the growth of blood vessels. Inhibiting both Ang2 and VEGF-A pathways can prevent the growth and leakage of abnormal blood vessels, which are common features of eye diseases such as wet age-related macular degeneration (wet AMD), diabetic macular edema (DME), and macular dystrophy.
Therapeutic Areas
Faricimab has shown promising results in clinical trials for the treatment of various eye diseases, including wet AMD, DME, and macular dystrophy. In wet AMD, Faricimab has demonstrated superior visual gains and fewer treatment visits compared to current standard-of-care anti-VEGF monotherapy. In DME, Faricimab has shown significant improvements in visual acuity and central subfield thickness compared to anti-VEGF monotherapy. In macular dystrophy, Faricimab has shown potential as a disease-modifying therapy that can slow down the progression of the disease.
Active Indications
Faricimab has been granted breakthrough therapy designation by the US Food and Drug Administration (FDA) for the treatment of wet AMD and DME. In clinical trials, Faricimab has shown superior efficacy and safety compared to anti-VEGF monotherapy, making it a potential first-line therapy for these indications. Additionally, Faricimab is currently being evaluated in phase III clinical trials for the treatment of macular dystrophy.
Inactive Indications
Apart from its active indications, Faricimab has also been evaluated in clinical trials for the treatment of choroidal neovascularization (CNV) and retinal vein occlusion (RVO). However, these indications are currently inactive, and further clinical trials are required to establish the efficacy and safety of Faricimab for these indications.
Approval Timeline
Faricimab is currently undergoing phase III clinical trials, and its approval timeline is subject to change based on the results of these trials. However, the breakthrough therapy designation granted by the FDA for wet AMD and DME indicates that Faricimab has shown promising results in clinical trials and may receive expedited approval once the final results are available.
Dosage and Administration
The recommended dosage of Faricimab is 6 mg administered via intravitreal injection every 8 weeks for the treatment of wet AMD and DME. The dosage and administration for macular dystrophy are currently under investigation in clinical trials.
Safety and Side Effects
In clinical trials, Faricimab has shown a favorable safety profile with no new safety signals identified. The most common adverse events reported in clinical trials include intraocular inflammation, increased intraocular pressure, and vitreous floaters. However, these adverse events were mostly mild to moderate in severity and resolved with standard treatments.
Conclusion
Faricimab is a promising drug for the treatment of various eye diseases, including wet AMD, DME, and macular dystrophy. Its unique mechanism of action, which targets both Ang2 and VEGF-A pathways, has shown superior efficacy and safety compared to current standard-of-care anti-VEGF monotherapy. With its breakthrough therapy designation and ongoing phase III clinical trials, Faricimab has the potential to become a game-changing therapy for patients with eye diseases.
References
[1] ClinicalTrials.gov. Phase 3 Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Neovascular Age-Related Macular Degeneration (TENAYA). https://clinicaltrials.gov/ct2/show/NCT03823287
[2] ClinicalTrials.gov. A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Diabetic Macular Edema (YOSEMITE). https://clinicaltrials.gov/ct2/show/NCT03622593
[3] ClinicalTrials.gov. A Study to Evaluate the Safety and Efficacy of Faricimab (RO6867461) in Participants With Macular Dystrophy. https://clinicaltrials.gov/ct2/show/NCT04723546
[4] Genentech. Faricimab. https://www.gene.com/patients/medicines/faricimab
[5] US FDA. FDA grants Breakthrough Therapy Designation to Genentech’s faricimab for the treatment of wet age-related macular degeneration (AMD). https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-breakthrough-therapy-designation-genentechs-faricimab-treatment-wet-age-related-macular
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