The FDA has recently accepted Genentech’s Biologics License Application (BLA) under priority review. This application was for faricimab, a bispecific antibody meant to treat ocular disorders, such as wet age-related macular degeneration (wAMD) and diabetic macular edema. Four Phase III trials support this application, and Genentech hopes to see this become a treatment option for millions.
BLA Acceptance for Faricimab
Faricimab treats ocular disorders by targeting two different pathways: vascular endothelial growth factor-A (VEGF-A) and angiopoietin-2 (Ang-2). These pathways play important roles in retinal conditions and vision loss, as they destabilize the blood vessels. When faricimab is able to block these pathways, the blood vessels are stabilized, and inflammation and leaky vessels may be reduced.
The BLA submission for this drug was based on four different Phase III trials: TENAYA, LUCERNE, YOSEMITE, and RHINE. The first two trials examined faricimab in wAMD patients, and they both met their endpoint with no new or unexpected safety signals identified. The latter two trials evaluated this treatment in DME patients. Again, these trials met their primary endpoints.
In addition, these studies proved that patients can go a minimum of three months in between doses, meaning that faricimab is more convenient for patients. Across the four Phase III studies, approximately half of patients receiving faricimab could extend treatment time to every four months and approximately three-quarters of people eligible for extended dosing with faricimab were able to be treated every three months or longer in the first year.
Genentech is still investigating faricimab in long-term extension studies. AVONELLE X is an extension of TENAYA and LUCERNE and will evaluate the long-term efficacy and safety of the drug in wAMD patients. RHONE X is an extension of the remaining two trials, and it enrolled DME patients to understand the efficacy and safety as well.
As DME and wAMD are two of the leading causes of vision loss in the United States, hopefully, this treatment will be able to improve the lives of millions of patients.
Wet age-related macular degeneration – also referred to as wet macular degeneration – is one of two forms of macular degeneration. The other form, which is the dry type, is much more common. This chronic eye disorder leads to blurred vision or a blind spot in one’s visual field. In most cases, abnormal blood vessels grow into the macula before releasing blood or other fluids. These fluids then impact retinal function. Fluid can also leak from the choroid, which would cause a bump to form in the macula. Medical professionals aren’t quite sure why this happens, but they do know that it leads to symptoms like visual distortions, blurry spots in the field of vision, reduced central vision, trouble recognizing faces, issues with adapting to changes in light, lower brightness and intensity of colors, and problems reading due to the blurriness of print. There are treatments available; doctors may prescribe Eylea, Lucentis, Beovu, or Avastin; however, Avastin has not been approved by the FDA for ophthalmic use. They may also utilize photodynamic therapy, low vision rehabilitation, and photocoagulation. All of these options can work together to slow disease progression, stop further vision loss, and possibly even recover some of the lost vision.
Diabetic macular edema occurs when an excess of blood sugar damages or blocks the blood vessels of the retina in diabetes patients. When this happens, fluid and blood can leak into the retina. This leads to edema, also known as swelling, in the macula. This condition can lead to serious vision loss or even blindness.
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