- Source : PR Newswire
- Date : 2022-02-03
- Event type : Approved
- Companies : Roche
Clinical Trial Research at Wolfe Eye Clinic Contributes to FDA Approval of Genentech's Vabysmo , the First Bispecific Antibody for the Eye, Treating Two Vision Loss Causes
Vabysmo is the only injectable eye medicine approved simultaneously in the U.S. for wet age-related macular degeneration and diabetic macular edema, with flexible dosing regimens based on patient need.
DES MOINES, Iowa, Feb. 3, 2022 /PRNewswire/ -- In a press release Friday, Genentech announced approval of Vabysmo™ (faricimab-svoa), a new advancement in the treatment approach for Wet Age-Related Macular Degeneration (AMD) and diabetic macular edema (DME). Vabysmo is the only injectable eye medicine approved simultaneously in the U.S. for wet AMD and DME, with flexible dosing regimens based on patient need.
Vabysmo represents a new shift in treatment for both diseases as it is the first medication to address both the VEGF and ANG-2 pathways. Clinical trials leading to FDA approval showed that eyes treated with Vabysmo required less frequent injections to maintain vision compared to the medications that have been available, based on evaluation of the patient's anatomy and vision outcomes. Current standard of care for wet AMD and DME typically requires eye injections every one to two months, so this medication can significantly reduce that treatment burden.
Age-related macular degeneration (AMD) is a condition that affects the macula, the part of the eye that provides sharp, central vision needed for activities like reading, and is a leading cause of blindness for people aged 60 and over in the United States. Wet, or neovascular, AMD is an advanced form of the disease that can cause rapid and severe vision loss. Approximately 11 million people in the United States have some form of AMD, and of those, about 1.1 million have wet AMD1. With Vabysmo, people with wet AMD initially receive four monthly treatments. Based on anatomical and vision outcomes, they may receive subsequent treatments every two, three or four months depending on the response to treatment.
Diabetic Macular Edema (DME) is the leading cause of permanent vision loss among working aged Americans. DME can be managed with injection treatments to improve vision and prevent permanent vision loss. People with diabetes should get a dilated eye exam every year to check for vision complications, such as DME. People with DME who are candidates for use of Vabysmo, are initially given four monthly treatments. Subsequently their treatment may be extended or reduced based on anatomical and vision outcomes, with a range of one to four months between doses. A second approved treatment regimen for DME involves six monthly loading doses, followed by treatment every two months.
Iowa-based Wolfe Eye Clinic continues to be at the center of state-of-the-art research surrounding treatments for sight threatening diseases such as AMD and DME. Physicians at Wolfe Eye Clinic participated in the Phase II & III studies Stairway, Boulevard, Lucerne, Yosemite, Rhone-X and Avonelle-X and enrolled several patients to evaluate the safety of the Vabysmo regimen. The clinic is Iowa's only trial site for the Vabysmo trials which contributed to this exciting FDA approval.
"Continuing to find innovation in the new technology that can help our patients who suffer with retinal disease is a passion of the retina physicians at Wolfe Eye Clinic. We are most grateful for the generous patients who participated in the various clinical trials that ultimately lead to Vabysmo approval. Without these dedicated patients' medical advancements would not be possible," said Jared Nielsen, MD, MBA, FASRS, Retina Specialist and Director of Retinal Clinical Trials at Wolfe Eye Clinic.
"It's exciting to see approval for Vabysmo as yet another step in reducing treatment burden for our patients. This is the second big approval for our AMD patients in recent months. Our commitment to clinical trials and advancements for our patients who suffer from retina disease has never been stronger."
Wolfe Eye Clinic strives to serve every corner of Iowa with specialized care and breakthrough research. Data from various studies was presented and submitted to health experts across the globe. Genentech notes that Vabysmo will be available in the United States in the coming months. With over 40 locations in Iowa including main offices, family vision centers and outreach offices, research and clinical trials is another way Wolfe Eye Clinic is making state-of-the-art eye care accessible for all Iowans.
In medical practice since 1919, Wolfe Eye Clinic is a recognized regional diagnostic and surgical center offering a broad range of ophthalmology care services. Wolfe Eye Clinic has over 50 doctors providing patient care in over 40 communities throughout Iowa including their main offices in Ames, Carroll, Cedar Falls, Cedar Rapids, Fort Dodge, Iowa City, Marshalltown, Ottumwa, Pleasant Hill, Spencer, Waterloo and West Des Moines.
Wolfe Eye Clinic surgeons have specialized fellowship training in the areas of cataract and refractive surgery, cornea and external disease, glaucoma, pediatric ophthalmology and adult strabismus, cosmetic and medical oculofacial plastics, and medical and surgical retina.