ORLANDO, Fla.—Separate clinical trials on two serious eye diseases, one set focused on advanced age-related macular degeneration and the other on central retinal vein occlusion, are reporting positive results for the drug VEGF Trap-Eye, Together, the two retinal diseases affect more than two million patients in the United States and more than 34 million worldwide. New results from these phase-3 clinical trials will be presented today at the 115th Annual Meeting of the American Academy of Ophthalmology.
The comprehensive year-one findings of the VEGF Trap-Eye: Investigation of Efficacy and Safety in Wet AMD (VIEW) 1 and 2 studies will be reported by Ursula Schmidt-Erfurth, MD, of the Medical University of Vienna, Austria. Results of the Controlled Phase 3 Evaluation of Repeated intravitreal administration of VEGF Trap-Eye in Central retinal vein occlusion: Utility and Safety (COPERNICUS) study will be reported by Julia Haller, MD, of the Wills Eye Institute in Philadelphia.
VEGF Trap-Eye is a new type of anti-vascular endothelial growth factor (anti-VEGF) drug. Such drugs work by inhibiting a protein, VEGF, which promotes blood vessel growth. As a treatment for eye diseases, anti-VEGF drugs inhibit abnormal growth and permeability of blood vessels in the retina and other parts of the eye. Two other anti-VEGF drugs, Lucentis and the very similar Avastin, are currently the most widely used treatments for the "wet," or neovascular, form of age-related macular degeneration (AMD). Although the FDA-approved Lucentis is considered the standard treatment for wet AMD, 2011 results of the Comparison of AMD Treatment Trials (CATT) showed that Avastin is equivalent in effectiveness and safety when used at similar treatment intervals.
VEGF Trap-Eye is a specially designed fusion protein, with characteristics that allow it to more effectively bind VEGF generally and also bind more isoforms, or varieties, of VEGF. These traits were designed into the drug with the aim of providing longer-lasting benefit to patients. VEGF Trap-Eye was developed by Regeneron Pharmaceuticals.
VEGF Trap-Eye Makes the Grade in VIEW 1 and 2 Comparisons to Lucentis
These two related clinical trials involved nearly 2,500 patients at more than 300 medical office study sites in the United States, Europe, Asia and Latin America. The comprehensive results of the VIEW studies show that VEGF Trap-Eye is equivalent to Lucentis for preventing vision loss or improving vision when treatment occurs either monthly or every two months. At the one-year end point of the trials, results for patients who received VEGF Trap-Eye injections at one-month or two-month intervals showed that vision loss was halted in more than 90 percent of patients. The gain in ability to read three more lines on a vision chart is considered a clinically significant improvement in vision, and in this study approximately one-third of patients on VEGF Trap-Eye were able to read at least three more lines on a vision chart than they could before treatment. Also, safety and drug tolerance results were similar for the two drugs.
"The VIEW studies show that we can provide the same level of vision protection to AMD patients in half as many office visits," said Dr. Schmidt-Erfurth. "This could help relieve the significant time and cost burdens borne by AMD patients, their families, and their ophthalmologists."
The FDA is currently considering VEGF Trap-Eye for treatment of neovascular AMD.
COPERNICUS Results Look Positive for CRVO
Retinal vein occlusion is common in the US, ranking as the second- most prevalent retinal vascular disease after diabetic retinopathy. RVO is caused by blockage of either the central retinal vein (CRVO) or a branch vein. One serious result of blockage in CRVO is swelling of the macula, the center of the retina, which is vital to activities like reading and driving. Monthly VEGF Trap-Eye injections rapidly reduced COPERNICUS patients' macular edema.
About 56 percent of the 110 CRVO patients treated with VEGF Trap-Eye for six months experienced vision gains that allowed them to read at least three more lines on a vision chart than they could before treatment, while only about 12 percent of non-treated control patients gained a similar level of vision. Abnormal blood vessel growth was halted in all treated patients, but continued to develop in five control patients. Adverse effect rates were low and similar to those for other treatment protocols that involve eye injections. In upcoming months all COPERNICUS patients will receive VEGF Trap-Eye as needed, but no more than once a month.
"At one year, we'll be able to determine how durable VEGF Trap-Eye is and how best to use it to maintain vision gains," said Dr. Haller. "Also, we'll learn how well vision can be recovered in the control patients, now that they are receiving VEGF Trap-Eye therapy."
The 115th Annual Meeting of the American Academy of Ophthalmology is in session October 22 through 25 at the Orange County Convention Center in Orlando, Fla. It is the world's largest, most comprehensive ophthalmic education conference. More than 25,000 attendees and 500 companies gather each year to showcase the latest in ophthalmic technology, products and services. To learn more about the place Where All of Ophthalmology Meets, visit www.aao.org/annual_meeting.
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About the American Academy of Ophthalmology
The American Academy of Ophthalmology is the world's largest association of eye physicians and surgeons — Eye M.D.s — with more than 30,000 members worldwide. Eye health care is provided by the three "O's" – ophthalmologists, optometrists, and opticians. It is the ophthalmologist, or Eye M.D., who can treat it all: eye diseases, infections and injuries, and perform eye surgery. For more information, visit www.aao.org. The Academy's EyeSmart® public education program works to educate the public about the importance of eye health and to empower them to preserve their healthy vision, by providing the most trusted and medically accurate information about eye diseases, conditions and injuries. Visit www.geteyesmart.org to learn more.