staff (2014). "Medical gallery of Blausen Medical 2014". WikiJournal of Medicine 1 (2). DOI:10.15347/wjm/2014.010. ISSN 2002-4436. Illustration depicting diabetic retinopathy

FDA Approves EYLEA (aflibercept) To Treat All Stages of Diabetic Retinopathy, With Two Dosing Options Interview with: staff (2014). "Medical gallery of Blausen Medical 2014". WikiJournal of Medicine 1 (2). DOI:10.15347/wjm/2014.010. ISSN 2002-4436. Illustration depicting diabetic retinopathy

Illustration depicting diabetic retinopathy

Robert L. Vitti, MD, MBA
Vice President and Head, Ophthalmology
Regeneron Pharmaceuticals

Dr. Vitti discusses the recent announcement that the FDA has approved EYLEA to treat all stages of diabetic retinopathy. Can you provide additional background on this approval? Would you briefly explain diabetic retinopathy and it’s impact on patients?

Response: The FDA has approved EYLEA (aflibercept) Injection to treat all stages of diabetic retinopathy (DR). DR is the leading cause of blindness among working-aged American adults. Approximately 8 million people live with DR, a complication of diabetes characterized by damage to the blood vessels in the retina (per 2010 data).

The disease generally starts as non-proliferative diabetic retinopathy (NPDR) and often has no warning signs or symptoms. Over time, NPDR often progresses to proliferative diabetic retinopathy (PDR), a stage in which abnormal blood vessels grow on the surface of the retina and into the vitreous cavity, potentially causing severe vision loss.

Response:  How does EYLEA differ from other treatments for this condition? Is there a cost or QoL benefit?

Response: EYLEA is the only anti-VEGF treatment approved with two dosing options for diabetic retinopathy, allowing doctors to customize treatment to their patients’ needs.

As demonstrated in our pivotal PANORAMA trial, EYLEA improves diabetic retinopathy and prevents worsening disease that can lead to blindness. In the trial, 80% of patients who received EYLEA every 8 weeks had significant improvement in their diabetic retinopathy. Additionally, EYLEA reduced the risk of developing proliferative diabetic eye disease by 85% to 88% when dosed every 16 or 8 weeks, respectively, compared to sham (e.g., no treatment) What should readers take away from your report? 

Response: The FDA approval of EYLEA to treat DR provides a new option for doctors and patients to treat all stages of DR, and thereby reduce the risk of blindness.

Per Dr. David Brown, one of our investigators for the PANORAMA trial and Director of Research at Retina Consultants of Houston: “Millions of people have been robbed of their vision due to the progression of diabetic retinopathy. The prevention of worsening diabetic retinopathy with EYLEA provides a compelling rationale for early treatment of patients with this disease, particularly since eyes dosed with EYLEA as infrequently as every 16 weeks showed significant improvements in the pivotal PANORAMA trial.” Is there anything else you would like to add?

Response: In addition to our expanded diabetic retinopathy indication, EYLEA is currently approved in the U.S. for the treatment of patients with wet age-related macular degeneration (Wet AMD), macular edema following retinal vein occlusion (MEfRVO), and diabetic macular edema (DME).

Our goal is to further advance the treatment of retinal diseases. This year, we plan to begin clinical development of a higher dose formulation of EYLEA to determine whether it can safely provide improved efficacy and longer-lasting benefit. In addition, we are actively developing new molecular entities, and we are in earlier stages of development for gene therapies and other novel approaches. 

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May 17, 2019 @ 4:52 pm

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