FDA Approves New Drug for Macular Degeneration – Healthline

The Food and Drug Administration (FDA) has approved a new drug for treating two conditions that cause vision loss.
The drug Vabysmo (faricimab-svoa) treats wet age-related macular degeneration (AMD) and diabetic macular edema (DME), two of the leading causes of vision loss.
It’s the first injectable eye medication that has been approved for the treatment of both conditions and offers a more flexible dosing regimen than medications currently used.
“Vabysmo represents an important step forward for ophthalmology. It is the first bispecific antibody approved for the eye and a major advance in treating retinal conditions such as wet AMD and diabetic macular edema,” Dr. Charles C. Wykoff, a Vabysmo phase 3 investigator and director of research at Retina Consultants of Texas, said in a press release.
“With Vabysmo, we now have the opportunity to offer patients a medicine that could improve their vision, potentially lowering treatment burden with fewer injections over time,” he added.
Experts who spoke with Healthline say the drug is good news for people living with AMD and DME.
“We have medications that are already working well and treat these conditions. But the problem that they have is that patients have to receive these treatments frequently. Now, there’s a hope that… the treatment can be extended. That’s one piece of good news,” said Dr. Hossein Ameri, an ophthalmologist with the USC Roski Eye Institute at Keck Medicine of USC.
“Another one is that when you have more medications in the same field, you have more options,” Ameri told Healthline.
Wet age-related macular degeneration is one of the leading causes of low vision and vision loss in the United States.
In wet AMD, bleeding, leaking, and scarring are caused by the growth of abnormal blood vessels behind the retina. This causes people to lose their central vision, which is necessary to see sharp details.
In diabetic macular edema, the blood vessels found in the walls of the retina can weaken and form bulging pouches. These can leak blood and other fluids, which results in part of the retina swelling up and causing vision problems.
Without adequate treatment, people living with wet AMD and DME face a gradual loss of their central vision.
“In the absence of effective control, macular degeneration and diabetic macular edema cause progressive loss of central vision, leading to difficulty reading, potential loss of adequate vision for driving, loss of ability to discern faces, but rarely to loss of peripheral vision, such that vision generally remains adequate for safe self-care and walking unassisted,” said Dr. Howard R. Krauss, a surgical neuro-ophthalmologist and clinical professor of ophthalmology and neurosurgery at Saint John’s Cancer Institute at Providence Saint John’s Health Center in Santa Monica, California.
“Wet macular degeneration and diabetic macular edema affect an increasing number of people and are a leading cause of worldwide blindness. So, all breakthrough drugs which are available to treat these conditions are very welcome,” Krauss told Healthline.
Vabysmo works by targeting two pathways that are believed to play a role in vision loss: Ang-2 and VEGF-A.
By inhibiting these pathways, the drug reduces inflammation and leakage from blood vessels.
While similar medications already exist, they require more frequent eye injections. Treatment using Vabysmo involves fewer regular eye injections.
For people with wet AMD, the regimen involves four monthly injections initially and then, depending on the outcome, further treatment every 2, 3, or 4 months.
People with DME are also given four monthly injections at first, with follow-up injections every 1 to 4 months based on how the person responds.
“Most patients respond to current treatments, but the need for regular follow-up and sometimes eye injections remain a major challenge. Imagine someone who missed his/her treatment because he/she got sick or went on a family vacation, then lost vision,” Dr. Radwan Ajlan, an ophthalmologist at the University of Kansas Health System eye clinic, told Healthline.
“(Vabysmo) is helpful because it may decrease the number of injections patients receive,” he added.
The Healthline News team is committed to delivering content that adheres to the highest editorial standards for accuracy, sourcing, and objective analysis. Every news article is thoroughly fact-checked by members of our Integrity Network. Furthermore, we have a zero-tolerance policy regarding any level of plagiarism or malicious intent from our writers and contributors.
All Healthline News articles adhere to the following standards:

  1. All referenced studies and research papers must be from reputable and relevant peer-reviewed journals or academic associations.
  2. All studies, quotes, and statistics used in a news article must link to or reference the original source. The article must also clearly indicate why any statistics presented are relevant.
  3. All content related to new treatments, drugs, procedures, and so on must clearly describe availability, pricing, side effects, treatment target (e.g., HER2+), known interactions, and off-label use, if appropriate.
  4. All news articles must include original commentary from at least two qualified sources with appropriate credentials and links to relevant associations or published works.
  5. Any potential conflicts of interest related to a study or source must be clearly indicated to the reader.
  6. All news articles must include appropriate background information and context for the specific condition or topic.











OUR BRANDS

source