▎WuXiEdited by Kant Content Team

Regeneron Pharmaceuticals recently announced positive results from the QUASAR Phase 3 clinical trial. Analysis shows,Every 8 weeksEylea HD（aflibercept，8mg) withEvery 4 weeks with Eylea (aflibercept, 2 mg) compared to,Treatment of Retinal Vein Occlusion (RVO) Post-hoc analysis of non-inferiority in patients with macular edema.Patients who have completed the initial five monthly doses have93% were able to maintain the dosing regimen of once every 8 weeks.Regeneron stated,These data will support the company in2025The first quarter of the year in the United StatesFDASubmit a Supplemental Biologics License Application.

Retinal Vein Occlusion is the second leading cause of vision loss among retinal vascular diseases, with a higher incidence in older patients or those with hypertension, diabetes, high cholesterol, a history of smoking, or other conditions affecting vascular health.Retinal vein occlusion often causes sudden, painless blindness in the affected eye, as the vein blockage restricts normal retinal blood flow, leading to ischemia, hemorrhage, exudation, and retinal swelling (i.e., macular edema).Macular edema caused by retinal vein occlusion often requires repeated intravitreal injections of anti-vascular endothelial growth factor (VEGF) drugs, which imposes a burden on patients.

QUASARThe trial evaluatedEylea HDUsed for treatmentRVOPost-macular edema patientsEfficacy and Safety, including patients with central, branch, and hemiretinal vein occlusion.The analysis shows,QUASAR Trial Met Primary Endpoint at 36 Weeks with Every-8-Week DosingAdministrationThe two groups of Eylea HD patients showed non-inferiority in vision improvement compared to those receiving Eylea treatment every 4 weeks.Eylea HD Shows Consistent Efficacy in Patients with Branch Retinal Vein Occlusion and Central or Hemi-Retinal Vein Occlusion.Moreover, in patients receiving Eylea HD treatment for 36 weeks,After the initial three monthly doses, 88% of patients were able to maintain the dosing regimen of once every 8 weeks, and after completing the initial five monthly doses, this proportion increased to 93%.

In the QUASAR trial, the safety of Eylea HD (591 cases) was similar to that of Eylea (301 cases) and generally consistent with the known safety profile of Eylea HD from previous pivotal trials.

Eylea is an ocular injectable agent with the main component being a VEGF inhibitor.Its mechanism of action is to block the growth factors VEGF-A and placental growth factor (PLGF) involved in angiogenesis, thereby inhibiting new blood vessel formation and reducing intraocular vascular permeability.The safety and efficacy of Eylea are supported by numerous trials, including eight pivotal Phase 3 trials and over 11 years of real-world evidence.World data, etc.Currently, Eylea has been approved by the FDA for the treatment of wet age-related macular degeneration (AMD), macular edema following retinal vein occlusion, diabetic macular edema (DME), diabetic retinopathy (DR), andRetinopathy of Prematurity (ROP)。

References:

[1] EYLEA HD® (aflibercept) Injection 8 mg Positive Phase 3 Results in Patients with Macular Edema following Retinal Vein Occlusion Presented at Angiogenesis Meeting. Retrieved February 10, 2025 from https://www.globenewswire.com/news-release/2025/02/08/3023111/0/en/EYLEA-HD-aflibercept-Injection-8-mg-Positive-Phase-3-Results-in-Patients-with-Macular-Edema-following-Retinal-Vein-Occlusion-Presented-at-Angiogenesis-Meeting.html

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