Is EYLEA Approved for DME?: Understanding Its Role in Diabetic Macular Edema

October 10, 2025 •

2 min read

In July 2014, the U.S. Food and Drug Administration (FDA) first approved EYLEA (aflibercept) for the treatment of diabetic macular edema (DME). This pivotal approval, based on robust clinical trial data, established EYLEA as a standard of care for a significant complication of diabetic eye disease.

Quick Summary

EYLEA is a prescription medication with full FDA approval for treating diabetic macular edema (DME). As an anti-VEGF therapy, it works by reducing fluid leakage from blood vessels in the macula, helping to improve or maintain vision.

Key Points

FDA Approval Confirmed: EYLEA (aflibercept) is officially approved by the FDA for the treatment of diabetic macular edema (DME), with the initial 2mg dose approved in 2014 and the higher-dose 8mg EYLEA HD approved in 2023.
VEGF Inhibitor Mechanism: EYLEA works by blocking vascular endothelial growth factor (VEGF) and placental growth factor (PlGF), which reduces the growth of abnormal blood vessels and decreases fluid leakage in the macula.
Effective Treatment for DME: Clinical trials have shown that EYLEA effectively improves and maintains visual acuity in patients with DME, with some comparative studies demonstrating superior results over other anti-VEGF drugs in patients with worse vision at baseline.
Flexible Dosing Options: With both a 2mg and 8mg formulation available, patients can benefit from different dosing approaches as determined by their healthcare provider. EYLEA HD offers the potential for extended dosing intervals for some patients.
Standard Injection Risks: EYLEA is administered via an injection into the eye, with common side effects including eye redness, pain, and floaters. Rare but more serious risks include infection, retinal detachment, and increased intraocular pressure.
Reduces Treatment Burden: The approval of the higher-dose EYLEA HD was a significant advancement, potentially allowing many patients to maintain vision with fewer injections throughout the year, which helps reduce the burden of frequent clinical visits.

What is EYLEA and How Does It Work?

EYLEA (aflibercept) is an anti-VEGF medication administered by injection into the eye. It targets vascular endothelial growth factor (VEGF), a protein that promotes blood vessel growth and leakage. In DME, high blood sugar damages retinal blood vessels, causing fluid leakage into the macula. By blocking VEGF, EYLEA reduces abnormal blood vessel growth and leakage, thereby decreasing macular swelling and helping to preserve or improve vision.

The FDA Approval Journey for EYLEA and DME

EYLEA's approval for DME stemmed from Phase 3 VISTA-DME and VIVID-DME trials, leading to initial FDA approval in 2014. This provided a new treatment option for DME patients. In August 2023, EYLEA HD (aflibercept 8 mg) was approved by the FDA for DME, wet age-related macular degeneration (wAMD), and diabetic retinopathy (DR). This was based on the PHOTON trial, showing that EYLEA HD achieved similar vision gains to the 2 mg dose, potentially allowing for extended dosing intervals.

Clinical Efficacy and Comparative Studies

Multiple studies have shown EYLEA's effectiveness for DME. The DRCR.net Protocol T trial compared EYLEA, Lucentis, and Avastin. Key findings included:

Superiority in Moderate-to-Severe Vision Loss: EYLEA showed better visual outcomes at one year compared to Lucentis and Avastin for patients with moderate or worse vision loss at the start.
Similar Efficacy in Mild Vision Loss: All three drugs were similarly effective for patients with milder vision loss at baseline.
Reduced Need for Rescue Laser: EYLEA was associated with fewer patients needing laser treatment for persistent edema.

Comparison: EYLEA 2mg vs. EYLEA HD 8mg for DME


Feature	EYLEA (2 mg)	EYLEA HD (8 mg)
Active Ingredient	Aflibercept	Aflibercept
Key Benefit	Proven efficacy and established safety profile	Potential for less frequent injections, potentially reducing treatment burden

Potential Side Effects of EYLEA

EYLEA, like any injection, has potential side effects, mostly related to the procedure. Common side effects include eye redness, pain, increased eye pressure, and floaters. Serious but rare risks include infection (endophthalmitis), retinal detachment, or inflammation. Patients should report any concerning symptoms immediately. There is also a potential risk of arterial thromboembolic events, such as stroke or heart attack.

Conclusion

EYLEA is definitively FDA-approved for DME and has been a key treatment since 2014. The approval of EYLEA HD in 2023 offers the potential for extended treatment intervals while maintaining vision. Patients with DME should discuss treatment options with their ophthalmologist to determine the best approach.

For more information on eye health, consider visiting the American Academy of Ophthalmology.

Frequently Asked Questions

Yes, EYLEA HD (aflibercept 8 mg) received FDA approval for the treatment of DME in August 2023. This higher-dose formulation offers patients the potential for extended dosing intervals compared to the standard EYLEA 2 mg dose, as determined by a healthcare professional.

EYLEA is a vascular endothelial growth factor (VEGF) inhibitor. It treats DME by blocking the action of VEGF, which is a protein that causes blood vessels to leak and promotes the growth of abnormal vessels in the retina, leading to macular swelling and vision loss.

The dosing schedule for EYLEA can vary depending on the specific formulation (2 mg or 8 mg EYLEA HD) and individual patient needs. A healthcare professional will determine the appropriate schedule.

Both EYLEA and Lucentis are anti-VEGF drugs, but comparative clinical trials showed EYLEA provided superior visual gains for patients with moderate to worse vision loss, particularly in the first year of treatment. For patients with mild vision loss, the two drugs showed similar efficacy.

Common side effects include eye pain, redness (conjunctival hemorrhage), increased intraocular pressure, and vitreous floaters. Most side effects are related to the injection procedure itself.

No, EYLEA is not a cure for DME. It is a long-term treatment that helps manage the condition by reducing macular edema and improving or maintaining vision. Continued monitoring and injections, as determined by a healthcare professional, are typically necessary for a sustained effect.

Yes, there is a potential risk of arterial thromboembolic events (ATEs), such as nonfatal stroke or myocardial infarction, with the use of anti-VEGF inhibitors like EYLEA. Clinical trial data showed that these events occurred at similar rates across different anti-VEGF treatment groups.