FDA Approves Extended-Release Aflibercept for Retinal Vein Occlusion, Expanding Treatment Options
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The Food and Drug Administration has approved a higher-dose formulation of aflibercept injection (Eylea HD; Regeneron, Bayer Healthcare) for the treatment of macular edema following retinal vein occlusion (RVO), offering patients the potential for less frequent injections. The approval also expands dosing versatility for individuals with other vision-threatening conditions.
New Dosing Regimen for RVO Offers Relief
The newly approved 8-mg aflibercept injection allows for dosing intervals of up to every eight weeks following an initial series of monthly injections. This is a notable advancement for patients with RVO, which includes central retinal vein occlusion, branch retinal vein occlusion, and hemiretinal vein occlusion.
Broader Submission for Existing Eye Condition Treatments
Beyond RVO, the FDA also approved a four-week dosing option for patients with wet age-related macular degeneration (wAMD), diabetic macular edema (DME), diabetic retinopathy (DR), and RVO who may benefit from a more frequent treatment schedule. This provides physicians with greater flexibility to tailor treatment plans to individual patient needs.
Aflibercept, a vascular endothelial growth factor (VEGF) inhibitor, has a well-established efficacy and safety profile, supported by data from 16 clinical trials. It is currently approved to treat a range of vision-threatening conditions, from retinopathy of prematurity (ROP) in newborns to DME, DR, macular edema following RVO, and wAMD in adults.
QUASAR Trial Demonstrates Efficacy and Safety
The approval for RVO treatment is based on the results of the QUASAR trial (NCT05850520), a global, double-masked, active-controlled phase 3 study. The trial evaluated the 8-mg aflibercept injection in patients with macular edema secondary to RVO. Participants were randomly assigned to one of three groups: injections every eight weeks after three initial monthly doses; injections every eight weeks after five initial monthly doses; or injections every four weeks.
The primary endpoint of the QUASAR trial was the mean change in best-corrected visual acuity from randomization through week 36, measured using the Early Treatment Diabetic Retinopathy Study letter score. According to a company release, the trial successfully met its primary endpoint. Patients receiving the 8-mg aflibercept injection every eight weeks after either three or five monthly doses demonstrated visual acuity gains that were noninferior to those receiving injections every four weeks. investigators also noted consistent results across patients with different types of retinal vein occlusions.
Safety Profile Remains Consistent
The safety profile of the 8-mg aflibercept injection was similar to that of the existing formulation in the QUASAR trial and remained consistent with previously established safety data. Ocular treatment-emergent adverse events (TEAEs) occurring in 5% or more of patients included increased ocular pressure. Isolated cases of endophthalmitis and retinal vasculitis were also reported. The rate of intraocular inflammation was approximately 0.5% with the 8-mg injection and 1.3% with the standard aflibercept. Hypertension was present at baseline in approximately 66% and 62% of patients receiving the respective treatments, and developed during the trial in about 8.1% and 4.7% of patients. Thromboembolic events occured in 0.5% and 1.7% of patients in these groups, respectively.
“We believe these approvals further position [aflibercept injection] as a treatment of choice for certain retinal diseases and underscore our relentless commitment to meeting the needs of patients and the retina specialists who treat them,” stated George D. Yancopoulos, MD, PhD, cofounder, board cochair, president, and chief scientific officer at Regeneron. “This is the first treatment for retinal vein occlusion that can perhaps cut the number of injections that patients receive in half compared to existing therapies. And with the addition of a monthly dosing option for all four approved [aflibercept injection] indications, physicians now have greater flexibility and optionality to tailor treatment to meet individual patient needs.”
The approvals represent a significant advancement in the treatment of several leading causes of vision loss, offering patients and physicians more tailored and convenient options.
