(RTTNews) - Regeneron Pharmaceuticals, Inc. (REGN) announced that the U.S. Food and Drug Administration (FDA) has approved the extension of dosing intervals for EYLEA HD (Aflibercept) up to every 20 weeks for patients with wet age-related macular degeneration (wAMD) and diabetic macular edema (DME).
This is based on the 96-week data from PULSAR and PHOTON pivotal trials in which EYLEA HD patients maintained their visual and anatomic improvements with extended dosing intervals.
Company Profile
Regeneron Pharma develops product candidates to treat eye, allergic and inflammatory, cardiovascular, metabolic, neurological, infectious, and rare diseases, as well as cancer and hematologic conditions.
EYLEA HD (aflibercept) Injection 8 mg is a prescription medicine approved for the treatment of patients with Wet Age-Related Macular Degeneration (AMD), Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR) and Macular Edema following Retinal Vein Occlusion (RVO).
EYLEA HD was developed to achieve efficacy and safety comparable to EYLEA, with fewer injections.
EYLEA (aflibercept) Injection 2 mg is a prescription medicine approved for the treatment of patients with Wet Age-Related Macular Degeneration, Macular Edema following Retinal Vein Occlusion, Diabetic Macular Edema, Diabetic Retinopathy, and Retinopathy of Prematurity (0.4 mg).
Trial Results
PULSAR in wAMD and PHOTON in DME/Diabetic Retinopathy (DR) were double-masked, active-controlled pivotal trials conducted at multiple centers worldwide. The lead sponsors of the trials were Bayer for PULSAR and Regeneron for PHOTON.
Among EYLEA HD patients who completed week 96, the vast majority maintained or further extended their dosing intervals, while visual and anatomic improvements remained consistent with those achieved during the first 48 weeks.
The results showed that 71% and 47% of wAMD patients reached the last assigned dosing interval of 16 or more weeks and 20 or more weeks, respectively, at week 96.
72% and 44% of DME patients attained the last assigned dosing intervals of 16 or more and 20 or more weeks, respectively, at week 96.
FDA Approval
In Neovascular (Wet) Age-Related Macular Degeneration (nAMD) and DME, the currently approved extended dosing interval of 8 mg every 20 ± 1 weeks may be considered after one year of successful response, based on visual and anatomic outcomes.
Also, EYLEA HD dosing can now be individualised for patients with wAMD and DME, with some requiring treatment as frequently as every 4 weeks and others successfully extended to every 20 weeks, based on criteria described in the U.S. Prescribing Information.
As part of the approval, the FDA has updated the EYLEA HD label to include 96-week (2-year) data from the pivotal PULSAR trial in wAMD and the pivotal PHOTON trial in DME, demonstrating sustained efficacy and safety through 2 years with extended dosing intervals.
Favourable Drivers
New EYLEA HD dosing regimen allows patients with wAMD and DME to be treated as infrequently as 2 to 3 times a year, further extending the widest range of dosing intervals of any approved injectable anti-VEGF, according to the firm.
Wet age-related macular degeneration (wAMD) is a retinal disease that may affect people as they age. It occurs when abnormal blood vessels grow and leak fluid under the macula, the part of the eye responsible for sharp central vision. The firm estimates that 1.4 million Americans have wAMD.
Diabetic Retinopathy is an eye disease characterised by microvascular damage to the retina, often caused by poor blood sugar control in people with diabetes.
The firm noted that in the U.S., approximately 1.5 million adults are diagnosed with DME, while approximately 6 million people have DR without DME.
Beyond today's approval, the FDA also has a target action date in April 2026 for the EYLEA HD prefilled syringe, which is under review through a Chemistry, Manufacturing and Controls Prior-Approval Supplement.
Limitations
The most common adverse reactions (=3%) reported in patients treated with EYLEA HD across approved indications were cataract, conjunctival hemorrhage, corneal epithelium defect, increased intraocular pressure, ocular discomfort/eye pain/eye irritation, retinal haemorrhage, blurred vision, vitreous detachment and vitreous floaters.
Conclusion
"We have once again raised the bar by offering the first and only injectable anti-VEGF therapy that gives patients the potential to be treated as infrequently as every 5 months", said George D. Yancopoulos, Board co-Chair, President and Chief Scientific Officer at Regeneron.
REGN has traded between $476.49 and $821.11 in the last year. The stock closed Thursday's trade (April 2, 2026) at $761.85, down 1.98%. In the pre-market, REGN is at $760.00, down 0.24%.
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