Mode
Text Size
Log in / Sign up

FDA approved Yesafili (aflibercept) for Neovascular AMD, RVO, DME, and DRFDA approved new eye injection drug Yesafili for four vision conditions

AI-generated summary of the cited source, checked by automated accuracy review. How we work

Key Takeaway
Consider Yesafili as a treatment option for wet AMD, RVO, DME, and DR, with dosing per label.

The FDA has approved Yesafili (aflibercept) for the treatment of four retinal conditions: neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), and diabetic retinopathy (DR). Yesafili is a vascular endothelial growth factor (VEGF) inhibitor administered by intravitreal injection, offering a new treatment option for these common causes of vision loss.

For clinicians, this approval expands the therapeutic armamentarium for managing these chronic retinal diseases. The recommended dosing regimens vary by indication, with initial monthly injections followed by extended intervals for AMD, DME, and DR, while RVO is treated with monthly injections. The label notes that while more frequent dosing is possible, additional efficacy was not demonstrated in most patients when compared to the recommended every-8-week regimen.

Yesafili is supplied as a pre-filled syringe or vial kit, and must be administered by a qualified physician. As with other anti-VEGF agents, clinicians should be aware of potential risks, though specific warnings and contraindications are not detailed in the provided label text.

Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Mechanism of Action

Yesafili is a vascular endothelial growth factor (VEGF) inhibitor. It binds to VEGF, thereby preventing its interaction with receptors on the surface of endothelial cells, reducing pathological angiogenesis and vascular permeability.

Indication & Patient Population

Yesafili is indicated for the treatment of: - Neovascular (Wet) Age-Related Macular Degeneration (AMD) - Macular Edema Following Retinal Vein Occlusion (RVO) - Diabetic Macular Edema (DME) - Diabetic Retinopathy (DR)

Dosing & Administration

- For neovascular AMD: 2 mg (0.05 mL of 40 mg/mL solution) by intravitreal injection every 4 weeks (monthly) for the first 3 months, followed by 2 mg every 8 weeks (2 months). Some patients may need monthly dosing after the first 12 weeks. After one year of effective therapy, some patients may be treated every 12 weeks, though this is not as effective as the every-8-week regimen. - For macular edema following RVO: 2 mg (0.05 mL) by intravitreal injection once every 4 weeks (monthly). - For DME and DR: 2 mg (0.05 mL) by intravitreal injection every 4 weeks for the first 5 injections, followed by 2 mg every 8 weeks. Some patients may need monthly dosing after the first 20 weeks. - Yesafili must only be administered by a qualified physician. It is for ophthalmic intravitreal injection. The pre-filled syringe requires a 30-gauge × ½-inch sterile injection needle (not provided). The vial requires a 5-micron sterile filter needle (18-gauge × 1½-inch), a 1-mL Luer lock syringe, and a 30-gauge × ½-inch sterile injection needle.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Not reported in label.

Place in Therapy

Yesafili is a VEGF inhibitor that provides a treatment option for four major retinal diseases. Its dosing regimen offers flexibility, with the potential for extended intervals after initial loading doses. As with other anti-VEGF agents, it is administered via intravitreal injection by a qualified physician. The label notes that more frequent dosing did not demonstrate additional efficacy in most patients, supporting the recommended every-8-week maintenance regimen for most indications.

The U.S. Food and Drug Administration (FDA) has approved a new medicine called Yesafili (aflibercept) for treating four eye conditions that can lead to vision loss. These conditions are wet age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), and diabetic retinopathy (DR). Yesafili is given as an injection into the eye by a doctor. It works by blocking a protein that causes abnormal blood vessel growth and leakage in the retina.

This approval is for adults who have one of these conditions. The medicine is not a cure, but it can help slow vision loss and, in some cases, improve vision. The dosing schedule varies depending on the condition. For most patients, injections are given once a month for the first few months, then less often. For some conditions, the doctor may recommend injections every eight weeks.

Yesafili is similar to other anti-VEGF drugs already on the market, such as Eylea. It offers another choice for patients and doctors. However, the approval does not mean Yesafili is more effective than existing treatments. It is important to remember that every patient is different, and what works for one person may not work for another.

If you have one of these eye conditions, talk to your eye doctor about whether Yesafili might be a good option for you. Your doctor can explain the potential benefits and risks, and help you decide on the best treatment plan. Always follow your doctor's advice and never change your treatment without consulting them.

What this means for you:
Yesafili is a new FDA-approved eye injection for four vision conditions, but talk to your doctor to see if it's right for you.

Study Details

Study typeFda approval
PublishedMay 2024
View Original Abstract ↓
1 INDICATIONS AND USAGE YESAFILI is indicated for the treatment of: YESAFILI is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with: • Neovascular (Wet) Age-Related Macular Degeneration (AMD) ( 1.1 ) • Macular Edema Following Retinal Vein Occlusion (RVO) ( 1.2 ) • Diabetic Macular Edema (DME) ( 1.3 ) • Diabetic Retinopathy (DR) ( 1.4 ) 1.1 Neovascular (Wet) Age-Related Macular Degeneration (AMD) 1.2 Macular Edema Following Retinal Vein Occlusion (RVO) 1.3 Diabetic Macular Edema (DME) 1.4 Diabetic Retinopathy (DR)
Free Newsletter

Clinical research that matters. Delivered to your inbox.

Join thousands of clinicians and researchers. No spam, unsubscribe anytime.