Welcome to the latest edition of our Guidelines+ Monographs Series. In this installment, we will delve into the medication aflibercept, marketed under the brand name Eylea by Regeneron Pharmaceuticals, Inc. Eylea a is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with Neovascular (Wet) Age-Related Macular Degeneration (AMD), Macular Edema Following Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME), Diabetic Retinopathy (DR), and Retinopathy of Prematurity (ROP). It was initially approved in 2011.
In the following sections, we will provide a comprehensive overview of aflibercept and analyze its positioning across various guidelines for its approved indications.
Note* – This Guidelines+ Monographs for aflibercept (Eylea) is current as of October 2024. Consult our clinical guidelines library and/or or medication information lookup tool to ensure you are always accessing the most current information.
Medication Overview:
- Brand name: Eylea
- Generic name: aflibercept
- Manufacturer(s): Regeneron Pharmaceuticals, Inc.
- Initial FDA approval: 2011
Indications and FDA Approval Details
| Indicated Condition | Indicated | Age Range | Date Approved |
|---|---|---|---|
| Neovascular (Wet) Age-Related Macular Degeneration (AMD) | for treatment of wet AMD | Adults | November 2011 |
| Macular Edema Following Retinal Vein Occlusion (RVO) | for treatment of macular edema following RVO | Adults | October 2014 |
| Diabetic Macular Edema (DME) | for treatment of DME | Adults | July 2014 |
| Diabetic Retinopathy (DR) | for treatment of DR | Adults | May 2019 |
| Retinopathy of Prematurity (ROP) | for treatment of ROP | Preterm Infants | February 2023 |
Dosage and Administration
- Neovascular (Wet) Age-Related Macular Degeneration (AMD)
- The recommended dose for Eylea is 2 mg (0.05 mL of 40 mg/mL solution) administered by intravitreal injection every 4 weeks (approximately every 28 days, monthly) for the first 3 months, followed by 2 mg (0.05 mL of 40 mg/mL solution) via intravitreal injection once every 8 weeks (2 months).
- Although Eylea may be dosed as frequently as 2 mg every 4 weeks (approximately every 25 days, monthly), additional efficacy was not demonstrated in most patients when Eylea was dosed every 4 weeks compared to every 8 weeks. Some patients may need every 4-week (monthly) dosing after the first 12 weeks (3 months).
- Although not as effective as the recommended every 8-week dosing regimen, patients may also be treated with one dose every 12 weeks after one year of effective therapy. Patients should be assessed regularly.
- Macular Edema Following Retinal Vein Occlusion (RVO)
- The recommended dose for Eylea is 2 mg (0.05 mL of 40 mg/mL solution) administered by intravitreal injection once every 4 weeks (approximately every 25 days, monthly).
- Diabetic Macular Edema (DME) and Diabetic Retinopathy (DR)
- The recommended dose for Eylea is 2 mg (0.05 mL of 40 mg/mL solution) administered by intravitreal injection every 4 weeks (approximately every 28 days, monthly) for the first 5 injections followed by 2 mg (0.05 mL of 40 mg/mL solution) via intravitreal injection once every 8 weeks (2 months).
- Although Eylea may be dosed as frequently as 2 mg every 4 weeks (approximately every 25 days, monthly), additional efficacy was not demonstrated in most patients when EYLEA was dosed every 4 weeks compared to every 8 weeks. Some patients may need every 4-week (monthly) dosing after the first 20 weeks (5 months).
- Retinopathy of Prematurity (ROP)
- The recommended dose for Eylea is 0.4 mg (0.01 mL or 10 microliters of 40 mg/mL solution) administered by intravitreal injection. Treatment may be given bilaterally on the same day. Injections may be repeated in each eye. The treatment interval between doses injected into the same eye should be at least 10 days.
Warnings and Precautions
- Endophthalmitis, retinal detachments, and retinal vasculitis with or without occlusion may occur following intravitreal injections. Patients and/or caregivers should be instructed to report any signs and/or symptoms suggestive of endophthalmitis, retinal detachment, or retinal vasculitis without delay and should be managed appropriately.
- Increases in intraocular pressure have been seen within 60 minutes of an intravitreal injection.
- In infants with ROP, treatment with Eylea will necessitate extended periods of ROP monitoring.
- There is a potential risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors.
Adverse Reactions
The most common adverse reactions (“5%) reported in patients receiving Eylea were conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and intraocular pressure increased.
Now that we’ve covered the basic monograph information for aflibercept, let’s take a closer look at how it is currently recommended in various clinical practice guidelines.
Specific Inclusions of Aflibercept in Clinical Guidelines
- Diabetic Retinopathy
- Authoring Society: American Academy of Ophthalmology (AAO)
- Publication: January 01, 2020
- AAO recommends Intravitreal anti-vascular endothelial growth factor (anti-VEGF) agents in the treatment of center-involved diabetic macular edema with vision loss.
- Treatment with laser, anti-VEGF agents, or intravitreal corticosteroids is cost-effective for managing diabetic retinopathy to varying degrees. Choice of laser, individual anti-VEGF agents, or approved intravitreal corticosteroids should be individually tailored based on discussion between the patient and physician.
- Age-Related Macular Degeneration
- Authoring Society: AAO
- Publication: January 1, 2020
- The most effective approach to managing neovascular AMD is through intravitreal injection therapy utilizing anti-vascular endothelial growth factor (VEGF) agents such as aflibercept, bevacizumab, and ranibizumab, which serve as the primary treatment modality. Any symptoms indicative of post-injection endophthalmitis or retinal detachment necessitate immediate evaluation to ensure optimal patient care.
- Eye Care Of The Patient With Diabetes Mellitus
- Authoring Society: American Optometric Association (AOA)
- Publication: October 01, 2019
- Patients diagnosed with severe or very severe nonproliferative diabetic retinopathy, early proliferative diabetic retinopathy at risk of progression, or high-risk proliferative diabetic retinopathy should be promptly referred to an ophthalmologist specializing in the management of diabetic retinal disease. These patients may benefit from panretinal photocoagulation (PRP) or intravitreous anti-VEGF treatment.
- In the management of proliferative diabetic retinopathy (PDR), with or without diabetic macular edema (DME), anti-vascular endothelial growth factor (anti-VEGF) agents should be considered as a viable treatment option either alone or in conjunction with panretinal photocoagulation (PRP).
- For patients with central-involved diabetic macular edema (DME), it is recommended to seek treatment from an experienced ophthalmologist specializing in diabetic retinal disease. Treatment options may include anti-VEGF agents and/or focal/grid macular laser therapy, either immediately or as a subsequent or deferred approach.
- Management of Diabetic Macular Edema
- Authoring Society: American Society of Retinal Specialists (ASRS)
- Publication: April 1, 2019
- Various management approaches for diabetic macular edema (DME) may be considered, such as observation, laser photocoagulation, intravitreal pharmacotherapy with anti-VEGF agents or corticosteroids, or a combination of these interventions. The choice of management strategy will depend on the specific type of DME and the severity of associated diabetic retinopathy.
This concludes our Guidelines+ Monographs for aflibercept (Eylea). This list is current as of October 2024 and may be updated over time as new indications are approved and/or new guidelines published or updated. Sign up for alerts and stay informed on the latest published guidelines and articles.
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