FDA approves Vabysmo for macular edema due to retinal vein occlusion
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Key takeaways:
- The FDA approved Vabysmo for the treatment of macular edema following retinal vein occlusion.
- This is the third indication for Vabysmo.
The FDA approved Vabysmo for the treatment of macular edema following retinal vein occlusion, according to a press release from Genentech.
“Retinal vein occlusion affects over 28 million people worldwide and over a million people in the U.S., so there is a massive area of unmet need,” Christopher Brittain, vice president and global head of ophthalmology product development at Genentech, told Healio. “For RVO patients specifically, [Vabysmo] met its primary endpoint, as we shared previously, providing this early and sustained improvement in visual acuity noninferior to the previous standard of care.”
Vabysmo (faricimab-svoa), which targets and inhibits Ang-2 and VEGF-A pathways, previously demonstrated positive results in sustained vision improvement at 24 weeks compared with aflibercept in the phase 3 BALATON and COMINO studies, as well as efficacy in the drying of retinal fluid. Overall, Vabysmo was well tolerated and demonstrated safety results consistent with previous studies. Conjunctival hemorrhage was the most common adverse reaction in the studies (3%).
This is the third indication for Vabysmo, which was previously approved for the treatment of wet age-related macular degeneration and diabetic macular edema.
“It’s exciting because it’s the third indication, with such a robust amount of experience from the physicians and the community. That is one of the reasons why we are so excited that this approval has come in such a timely way,” Brittain said.
Vabysmo is approved in more than 80 countries for wet AMD and DME treatment, with approximately 2 million doses distributed globally, according to the release.
“In 2024, we are aiming to bring the prefilled syringe to the market. We know that prefilled syringes will make it easier to administer Vabysmo, so we are excited about bringing that to market,” Brittain said. “We are also going to be looking at additional indications for Vabysmo. We have not finalized those yet, but we will start to initiate new studies in the near future in new indications.”
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