FDA approves Vabysmo prefilled syringe for retinal diseases
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Key takeaways:
- The prefilled syringe is indicated for wet age-related macular degeneration, diabetic macular edema and retinal vein occlusion.
- The syringe will be available in the U.S. later this year.
The FDA approved the Vabysmo 6-mg single-dose prefilled syringe for the treatment of wet age-related macular degeneration, diabetic macular edema and macular edema following retinal vein occlusion, according to a Genentech press release.
Vabysmo (faricimab-svoa, Genentech) was previously approved for wet AMD, DME and retinal vein occlusion (RVO), according to the release, with the pre-filled syringe (PFS) offering an “alternative, ready-to-use format” for delivering the drug. It is the first and only bispecific antibody approved for the eye, and has demonstrated positive results in vision improvement and retinal drying in wet AMD, DME and RVO, according to the release.
“We are pleased that the U.S. FDA has approved the Vabysmo PFS for people living with wet AMD, DME and RVO, which are some of the leading causes of vision loss,” Levi Garraway, MD, PhD, chief medical officer and head of global product development for Genentech, said in the release. “While many retina specialists are already using Vabysmo as a first-line treatment, this new offering should make it even simpler to administer, thereby enhancing the treatment experience for both physicians and patients.”
Vabysmo will be available in the U.S. later this year.
Editor's note: This article was updated on July 5, 2024, to more accurately reflect the content of the press release.
Perspective
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Pre-filled syringes offer a myriad of benefits that streamline the treatment process, enhance patient safety and improve clinical efficiency. For ophthalmologists, these pre-filled syringes simplify the preparation and administration of Vabysmo, reducing the risk of contamination and dosing errors that can occur with traditional vial and syringe systems. This ease of use allows practitioners to focus more on patient care rather than procedural logistics.
The approval of pre-filled syringes addresses several unmet needs in ophthalmic care. Firstly, it minimizes preparation time, which is crucial in busy clinical settings where time management is essential. Secondly, it enhances the sterility of the medication, reducing the risk of infections — a significant concern in intravitreal injections. Thirdly, pre-filled syringes ensure accurate dosing, which is critical for the efficacy and safety of treatments like Vabysmo. Overall, the availability of prefilled syringes for faricimab represents a meaningful improvement in the standard of care for patients requiring intravitreal therapy.
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