Diabetic Eye Marketing Materials

VEGF Trap-Eye Submitted for EU Marketing Authorization for Treatment of Wet ...

Regeneron Pharmaceuticals and Bayer HealthCare announced that Bayer HealthCare has submitted an application for marketing authorization in Europe for VEGF Trap-Eye for the treatment of the neovascular form of age-related macular degeneration (wet AMD)

TARRYTOWN, NY, USA and BERLIN, GERMANY | June 7, 2011 | Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN - News) and Bayer HealthCare today announced that Bayer HealthCare has submitted an application for marketing authorization in Europe for VEGF Trap-Eye for the treatment of the neovascular form of age-related macular degeneration (wet AMD). Regeneron and Bayer HealthCare are collaborating on the global development of VEGF Trap-Eye for the treatment of wet AMD, central retinal vein occlusion (CRVO), diabetic macular edema (DME), and myopic choroidal neovascularization (mCNV).

"The submission of VEGF Trap-Eye for EU marketing authorization represents a significant milestone in our goal to bring this potentially important new therapy to patients with wet AMD across the globe," said Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron.

The VEGF Trap-Eye submission is based on the positive results from two Phase 3 trials, the VIEW 1 study and the VIEW 2 study. In these trials, all regimens of VEGF Trap-Eye, including 2 mg VEGF Trap-Eye dosed every two months (following three loading doses), successfully met the primary endpoint of non-inferiority, compared to the current standard of care, ranibizumab 0.5 mg dosed every month. The primary endpoint analysis was statistical non-inferiority in the proportion of patients who maintained (or improved) vision over 52 weeks compared to ranibizumab at the dose that is currently known to provide the best possible efficacy. A generally favorable safety profile was observed for both VEGF Trap-Eye and ranibizumab. The ocular adverse events were balanced across all treatment groups in both studies. There were no notable differences in non-ocular adverse events among the study arms.

Regeneron submitted a Biologics License Application (BLA) for marketing approval in wet AMD in the U.S. in February 2011 and received a Priority Review designation.

Bayer HealthCare will market VEGF Trap-Eye outside the United States, where the companies will share equally the profits from any future sales of VEGF Trap-Eye. Regeneron maintains exclusive rights to VEGF Trap-Eye in the United States.

NDOA named NEI 2011 Healthy Vision Community Award recipient ...

The 2011 Healthy Vision Community Awards (HVCA) winners announced by the National Eye Institute (NEI), part of the National Institutes of Health, included the North Dakota Optometric Association (NDOA) for its “Eating for Your Eyes II: Diabetic Retinopathy” project.

All award recipients are committed to making eye health and vision priorities in their communities. Through the HVCA, they can make a difference in communities across the nation.

The HVCA supports grassroots eye health education by providing awards up to $10,000. This seed money supplies the spark that gets projects started, which are then sustained through community partnerships.

“The North Dakota Optometric Association members are honored and pleased to be a recipient of a 2011 Healthy Vision Community Award provided by the National Eye Institute,” said Nancy Kopp, executive director of the NDOA. “This funding provides the NDOA and its dedicated partner, the North Dakota State University (NDSU) Health, Nutrition and Exercise Science Department, the opportunity to truly make a difference in increasing the education on eye health issues that are so very prevalent in our predominately senior population of our rural state.”

The “Eating for Your Eyes II:  Diabetic Retinopathy” project was designed to educate community members using pre-printed materials in a variety of settings. 

Delivery will be targeted to older adults and American Indians of all ages in North Dakota. 

Scripted PowerPoint slides, structured suggested activities with workshop tools (e.g., vision simulator cards from the AOA), take-home materials (e.g., Idaho Plate Method, brochures), evaluation surveys, and marketing materials are part of the program. 

Additionally, the program includes an eye examination postcard reminder that also serves as a communication between the eye care professional and primary care physician. 

Pre- and post-questionnaires are carefully matched to educational materials to assess learning. Follow-up telephone questionnaires are planned as part of the program.

“Eating for Your Eyes II: Diabetic Retinopathy” project directors are Kopp and Sherri Stastny, assistant professor, Health, Nutrition, and Exercise Science, NDSU, in collaboration with Julie Garden-Robinson, NDSU Extension.  

Diabetes is the seventh leading cause of death in the United States. Diabetic retinopathy accounts for 12,000 to 24,000 new cases of blindness every year and is the leading cause of new cases of blindness in adults.

Prevention of blindness from diabetes mellitus, report of a WHO consultation in Geneva, Switzerland, 9-11 November 2005

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