October 24, 2019
FDA Approves New Wet Age-Related Macular Degeneration Treatment Following Clinical Trials at Wolfe Eye Clinic
Wolfe Eye Clinic participated in clinical trials for BeovuÂ® (brolucizumab), the newly approved drug for wet age-related macular degeneration that may reduce the frequency of intravitreal injections.
On October 8th, 2019, the U.S. Food & Drug Administration (FDA) approved a new vascular endothelial growth factor inhibitor to treat wet age-related macular degeneration(AMD) otherwise known as neovascular AMD (i.e., nAMD). The highly anticipated approval of Novartis's BeovuÂ® (brolucizumab), is the first breakthrough for wet AMD patients since the approval of Eylea (aflibercept) in 20111.
Clinical trial results indicated that BeovuÂ® may reduce the burden of frequent injections to the eye (i.e., intravitreal injections)2. Having participated as a host for various clinical trials including Beovu, Wolfe Eye Clinic is excited for this treatment milestone to help further improve the lives of our patients with wet AMD.
Wet AMD is a leading cause of severe vision loss and blindness worldwide in adults over 65 according to the Centers for Disease Control and Prevention3. It is estimated that over 1.5 million people in the United States will have wet AMD by 20202. Wet AMD is a disease associated with age that attacks the part of the eye called the macula responsible for our central vision and the ability to see fine details5. Living with the disease can make everyday tasks difficult, if not impossible, such as reading, driving and identifying faces. Individuals affected often rely on others for daily assistance. If left untreated, vision may rapidly deteriorate.
Until now, treatment for wet AMD consisted of drug injections (e.g., aflibercept) into the eye as frequent as every month6. While the disease is considered "uncurable," injections help keep the disease in check by slowing down damage caused to the macula and prevent permanent vision loss. Clinical trials indicate that in comparison to aflibercept, another intravitreal injection drug option, Beovu may allow patients to go as little as three months without an injection and decrease the activity of the disease4,5.
Participating since 2015, Wolfe Eye Clinic served as a host cite for the phase three HAWK clinical trials which helped demonstrate the efficacy and safety of Beovu, ultimately leading to FDA approval.
"We are excited to have Beovu as a new option for patients who suffer Wet AMD to help preserve vision and reduce the burden of treatment," said Jared Nielsen, MD, MBA, Hawk Trial Principal Investigator, Retina Specialist and Director of Retinal Clinical Trials at Wolfe Eye Clinic, "this extends to friends and family who assist them in their care."
Wolfe Eye Clinic is a national leader in the advancement of new treatments for sight-threatening retinal diseases. The clinic is currently engaged in over 15 protocols working to develop better therapies for people who suffer from Age-related Macular Degeneration and Diabetic Retinopathy.
If you or a loved one have wet AMD and are wondering if BeovuÂ® can help, call (800) 542-7956 to make an appointment with one of our retina specialists.
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- Advocating for improved treatment and outcomes for wet age-related macular degeneration. https://angio.org/wp-content/uploads/2013/10/AMD_Final_Report_2012.pdf. Published 2012. Accessed October 10, 2019.
- Novartis announces FDA filing acceptance and priority review of brolucizumab (RTH258) for patients with wet AMD. Novartis. https://www.novartis.com/news/media-releases/novartis-announces-fda-filing-acceptance-and-priority-review-brolucizumab-rth258-patients-wet-amd. Published April 15, 2019. Accessed October 10, 2019.
- Learn about age-related macular degeneration. CDC. https://www.cdc.gov/features/healthyvisionmonth/index.html. Published July 18, 2018. Accessed October 10, 2019.
- Davio K. Could Novartis' brolucizumab beat biosimilar anti-VEGFs in ophthalmology? Center for Biosimilars. https://www.centerforbiosimilars.com/news/could-novartis-brolucizumab-beat-biosimilar-antivegfs-in-ophthalmology. Published April 20, 2019. Accessed October 10, 2019.
- Novartis receives FDA approval for BeovuÂ®, offering wet AMD patients vision gains and greater fluid reductions vs aflibercept. Novartis. https://www.novartis.com/news/media-releases/novartis-receives-fda-approval-beovu-offering-wet-amd-patients-vision-gains-and-greater-fluid-reductions-vs-aflibercept. Published October 8, 2019. Accessed October 10, 2019.
- Eylea injection treatment of macular degeration - AMDF. macular.org. https://www.macular.org/eylea-injection-treatment. Accessed October 10, 2019.