FARICIMAB

Background and Date of Approval

Faricimab received its initial approval from the United States Food and Drug Administration (FDA) on January 28, 2022. In the 2019 TENAYA/LUCERNE trials, faricimab and aflibercept demonstrated comparable improvements in vision over two years. Most patients receiving faricimab were able to undergo treatment at longer intervals, while ocular side effects were similar between the two therapies.

Uses

Faricimab treats several eye conditions. It reduces fluid buildup in the retina caused by Diabetic Macular Edema (DME), improving vision. It also treats Wet Age-Related Macular Degeneration (AMD) by stopping the growth of abnormal blood vessels in the eye, which can lead to vision loss in older adults. Faricimab reduces macular oedema in Retinal Vein Occlusion (RVO), helping restore vision. Additionally, it addresses vision problems caused by abnormal blood vessel growth in Myopic Choroidal Neovascularization (mCNV) due to severe nearsightedness.

How is it administered?

For Neovascular (Wet) Age-Related Macular Degeneration (nAMD), administer 6 mg (0.05 mL of 120 mg/mL solution) by intravitreal injection every 4 weeks for the first 4 doses. Afterwards, assess optical coherence tomography (OCT) and visual acuity at weeks 8 and 12 to determine the dosing schedule. Adjust the regimen as needed, with possible intervals of weeks 28 and 44, weeks 24, 36, and 48, or weeks 20, 28, 36, and 44. For Diabetic Macular Edema (DME), administer 6 mg every 4 weeks for at least 4 doses. If OCT shows resolution of oedema, adjust the dosing interval by up to 4 weeks or reduce it by up to 8 weeks. Please consult with a healthcare provider for personalised dosing adjustments.

Side Effects

Common side effects of Faricimab include: Conjunctival hemorrhage Vitreous floaters Retinal pigment epithelial tear Increased intraocular pressure Eye pain Intraocular inflammation Eye irritation Ocular discomfort Vitreous haemorrhage Serious side effects of Faricimab are: Corneal abrasion Eye pruritus Increased lacrimation Ocular hyperemia Blurred vision Eye irritation Sensation of foreign body in the eye Endophthalmitis Transient reduction in visual acuity Retinal tear Rhegmatogenous retinal detachment

Warnings

Endophthalmitis and retinal detachments: Intravitreal injections of faricimab can cause serious eye infections or retinal detachment. Always use clean techniques when giving the injection. Instruct patients to report any symptoms of eye infection or retinal detachment immediately so you can provide quick treatment. Increase in intraocular pressure: The injection may cause a temporary rise in eye pressure. Regularly check the patient's eye pressure and manage it to protect the optic nerve. Thromboembolic events: VEGF inhibitors like faricimab can increase the risk of serious blood clots, which can lead to stroke, heart attack, or other vascular issues.

Precautions

After giving Faricimab, keep an eye on the patient's eye pressure and optic nerve health. Make sure to use sterile techniques during the injection to avoid infections or retinal problems. Even though blood clots were rare in studies, watch for signs of these events, especially during the first year of treatment.

Word of Advice

Your doctor will determine the appropriate faricimab dosage and treatment schedule based on your clinical condition and response to therapy. A qualified healthcare professional will administer the injection in a clinical setting to ensure patient safety and correct injection technique. Before beginning or modifying faricimab treatment, discuss with your doctor and inform them of any health changes, particularly if you are pregnant, breastfeeding, or of reproductive potential.

References

1. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761235s000lbl.pdf 2. Shirley M. Faricimab: First Approval. https://pubmed.ncbi.nlm.nih.gov/35474059/ 3. Nair AA, Finn AP, Sternberg P Jr. Spotlight on Faricimab in the Treatment of Wet Age-Related Macular Degeneration: Design, Development and Place in Therapy. https://pubmed.ncbi.nlm.nih.gov/36199631/ 4. Liberski S, Wichrowska M, Kocięcki J. Aflibercept versus Faricimab in the Treatment of Neovascular Age-Related Macular Degeneration and Diabetic Macular Edema: A Review. https://pubmed.ncbi.nlm.nih.gov/36012690/

Frequently Asked Questions

What is faricimab used for?

Faricimab treats eye conditions like wet age-related macular degeneration, diabetic macular oedema, retinal vein occlusion, and myopic choroidal neovascularisation by targeting proteins that cause abnormal blood vessel growth and fluid leakage in the eye.

Is faricimab approved in India?

Faricimab was first approved by the USFDA in January 2022 and is now available in over 90 countries, including India. More than 2 million doses have been administered globally.

What are the risks of taking faricimab?

The risks of taking faricimab include eye infections, retinal detachments, and temporary increases in eye pressure. It may also increase the risk of blood clots, leading to serious events like stroke or heart attack. Your healthcare provider will monitor you for these risks during treatment.

How many injections are needed for faricimab?

The number of faricimab injections needed depends on the condition being treated and the patient's response. Initially, patients may receive injections every 4 weeks, with the frequency adjusted based on their progress and the healthcare provider's assessment.

What type of drug is faricimab?

Faricimab is a biologic drug, specifically a bispecific antibody. It targets and inhibits two proteins, VEGF-A and Ang-2, to treat eye conditions by reducing abnormal blood vessel growth and fluid leakage.

Available Brands 1

Written By: Muskan Patel, M.Pharm

Reviewed By: Dr. Vishwa Patel, MBBS