Expect U.S. regulatory submission for diabetic retinopathy later this year
TARRYTOWN, NY, USA I March 19, 2018 I Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the Phase 3 PANORAMA trial evaluating EYLEA® (aflibercept) Injection in moderately severe to severe non-proliferative diabetic retinopathy (NPDR) met its 24-week primary endpoint. In the trial, 58 percent of EYLEA-treated patients experienced a two-step or greater improvement from baseline on the Diabetic Retinopathy Severity Scale (DRSS) at week 24, compared to 6 percent of patients receiving sham injection (p<0.0001).
“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 George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer of Regeneron. “Patients in the trial continue to be evaluated to determine if EYLEA can prevent progression to neovascular vision-threatening complications or diabetic macular edema. We look forward to sharing one-year results later this year.”
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 U.S. Food and Drug Administration later this year.
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 U.S. As NPDR becomes more severe, DME can occur as the blood vessels in the retina become increasingly fragile and leak fluid, potentially causing visual impairment. NPDR may also progress to PDR, a stage of the disease in which abnormal blood vessels grow onto the surface of the retina and potentially cause severe, vision-threatening complications such as vitreous hemorrhage and traction retinal detachment.
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 U.S., EYLEA is the market-leading, FDA-approved anti-VEGF treatment for its approved indications and is supported by a robust body of research that includes seven pivotal Phase 3 trials.
INDICATIONS
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.
About Regeneron Pharmaceuticals, Inc.
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to six FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, heart disease, allergic and inflammatory diseases, pain, cancer, infectious diseases and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.
SOURCE: Regeneron Pharmaceuticals
Post Views: 27
Expect U.S. regulatory submission for diabetic retinopathy later this year
TARRYTOWN, NY, USA I March 19, 2018 I Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the Phase 3 PANORAMA trial evaluating EYLEA® (aflibercept) Injection in moderately severe to severe non-proliferative diabetic retinopathy (NPDR) met its 24-week primary endpoint. In the trial, 58 percent of EYLEA-treated patients experienced a two-step or greater improvement from baseline on the Diabetic Retinopathy Severity Scale (DRSS) at week 24, compared to 6 percent of patients receiving sham injection (p<0.0001).
“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 George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer of Regeneron. “Patients in the trial continue to be evaluated to determine if EYLEA can prevent progression to neovascular vision-threatening complications or diabetic macular edema. We look forward to sharing one-year results later this year.”
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 U.S. Food and Drug Administration later this year.
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 U.S. As NPDR becomes more severe, DME can occur as the blood vessels in the retina become increasingly fragile and leak fluid, potentially causing visual impairment. NPDR may also progress to PDR, a stage of the disease in which abnormal blood vessels grow onto the surface of the retina and potentially cause severe, vision-threatening complications such as vitreous hemorrhage and traction retinal detachment.
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 U.S., EYLEA is the market-leading, FDA-approved anti-VEGF treatment for its approved indications and is supported by a robust body of research that includes seven pivotal Phase 3 trials.
INDICATIONS
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.
About Regeneron Pharmaceuticals, Inc.
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to six FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, heart disease, allergic and inflammatory diseases, pain, cancer, infectious diseases and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.
SOURCE: Regeneron Pharmaceuticals
Post Views: 27
