EYLEA® (aflibercept) Injection Demonstrates Positive Topline Results in Phase 3 Non-Proliferative Diabetic Retinopathy Trial
"This is the first time a therapy has demonstrated it can reverse disease progression in patients with moderately severe to severe non-proliferative diabetic retinopathy without diabetic macular edema, in a trial specifically designed to study this population," said
Patients in the active treatment groups received, on average, 4.4 EYLEA injections during the first 24 weeks. There were no new safety signals in the trial. There was one case of mild intraocular inflammation (IOI) in a patient treated with EYLEA (0.085 percent rate per injection), which is consistent with the rate of IOI seen in previous clinical trials.
About the PANORAMA trial
PANORAMA is an ongoing, pivotal, double-masked, randomized two-year trial that enrolled 402 patients and is designed to investigate EYLEA for the improvement of moderately severe to severe NPDR without diabetic macular edema (DME), compared to sham injection. Details on trial design include:
- Three treatment arms - An observational sham injection group and two EYLEA treatment groups. The EYLEA treatment groups started with either three or five initial monthly doses, and the trial will evaluate every eight-week dosing or every 16-week dosing at one year.
- Two primary endpoints - Both assess the proportion of patients who experience a two-step or greater improvement in DRSS score from baseline. The first is measured at six months (24 weeks) and the second at one year (52 weeks). The DRSS is a systematic grading scale to assess the severity of diabetic retinopathy based on photographs of the retina following a dilated eye exam.
- Key secondary endpoints - These include assessment of whether EYLEA prevents neovascular vision-threatening complications (such as progression to proliferative diabetic retinopathy (PDR) and anterior segment neovascularization) or progression to DME, as well as its impact on other anatomic effects, visual acuity improvement, and safety. Some secondary endpoints will be measured for up to two years.
Results from PANORAMA will be submitted for presentation at a future medical congress. PANORAMA will also form the basis of a supplemental Biologics License Application (sBLA) to the
A separate ongoing trial sponsored by the Diabetic Retinopathy Clinical Research Network known as Protocol W is also evaluating EYLEA for the treatment of NPDR in patients without DME.
The safety and efficacy of the potential use of EYLEA in moderately severe to severe NPDR in patients without DME have not been fully evaluated by any regulatory authority.
About Diabetic Retinopathy
Approximately eight million people live with diabetic retinopathy, a disease characterized by microvascular damage to the blood vessels in the retina often caused by poor blood sugar control in people with diabetes. The disease starts as NPDR and generally has no warning signs or symptoms. Approximately 560,000 people live with moderately severe to severe NPDR without DME in the
About EYLEA® (aflibercept) Injection
EYLEA® (aflibercept) Injection is a vascular endothelial growth factor (VEGF) inhibitor formulated as an injection for the eye. It is designed to block the growth of new blood vessels and decrease the ability of fluid to pass through blood vessels (vascular permeability) in the eye by blocking VEGF-A and placental growth factor (PLGF), two growth factors involved in angiogenesis. In the
IMPORTANT SAFETY INFORMATION FOR EYLEA® (aflibercept) INJECTION
EYLEA® (aflibercept) Injection is a prescription medication administered by injection into the eye. You should not use EYLEA if you have an infection in or around the eye, eye pain or redness, or known allergies to any of the ingredients in EYLEA, including aflibercept.
Injection into the eye with EYLEA can result in an infection in the eye and retinal detachment (separation of retina from back of the eye). Inflammation in the eye has been reported with the use of EYLEA.
In some patients, injections with EYLEA may cause a temporary increase in eye pressure within 1 hour of the injection. Sustained increases in eye pressure have been reported with repeated injections, and your doctor may monitor this after each injection.
There is a potential risk of serious and sometimes fatal side effects related to blood clots, leading to heart attack or stroke in patients receiving EYLEA.
Serious side effects related to the injection procedure with EYLEA are rare but can occur including infection inside the eye and retinal detachment.
The most common side effects reported in patients receiving EYLEA are increased redness in the eye, eye pain, cataract, moving spots in the field of vision, increased pressure in the eye, and vitreous (gel-like substance) detachment.
It is important that you contact your doctor right away if you think you might be experiencing any side effects, including eye pain or redness, light sensitivity, or blurring of vision, after an injection.
EYLEA is for prescription use only. For additional safety information, please talk to your doctor and see the full Prescribing Information for EYLEA.
You are encouraged to report negative side effects of prescription drugs to the
EYLEA® (aflibercept) Injection is a prescription medicine approved for the treatment of patients with:
Wet Age-related Macular Degeneration (AMD): The recommended dose for EYLEA is 2 mg administered by injection in the eye every 2 months (8 weeks) following 3 initial monthly (every 4 weeks) injections. EYLEA may be dosed once per month, but in most patients, additional benefit was not seen with this dosing plan. Some patients may need monthly (every 4 weeks) dosing after the first 3 months (12 weeks).
Macular Edema following Retinal Vein Occlusion (RVO): The recommended dose for EYLEA is 2 mg administered by injection in the eye monthly (every 4 weeks).
Diabetic Macular Edema (DME) and Diabetic Retinopathy (DR) in patients with DME: The recommended dose for EYLEA is 2 mg administered by injection in the eye every 2 months (8 weeks) following 5 initial monthly (every 4 weeks) injections. EYLEA may be dosed once per month, but in most patients, additional benefit was not seen with this dosing plan. Some patients may need monthly (every 4 weeks) dosing after the first 5 months (20 weeks).
Please visit www.EYLEA.us to see the full Prescribing Information for EYLEA.
The information contained herein is provided for general educational purposes. If you have any questions, talk to your doctor.
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