Vabysmo solution for intravitreal injection (single-dose vial) does not contain any antimicrobial preservative.[1] Therefore, sterility of the solution must be ensured during in-use handling by maintaining appropriate aseptic conditions.

Recommendation for use of prepared Vabysmo injection

The prepared injection solution should be used immediately.[1] If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.

If the prepared Vabysmo intravitreal injection cannot be immediately administered, cap the drug-filled syringe with a combi-stopper and store in a refrigerator at 2°C to 8°C (36°F to 46°F) for up to 24 hours.[2]

In-use storage and stability considerations

The combi-stopper cap minimises the potential risk of contamination.[2] Identify on the cap the date and time of preparation.

Within the 24 hour in-use storage period, the drug-filled syringe may be held at 9°C to 25°C (47°F to 77°F) up to a maximum cumulative time of 6 hours, including the time required for warming up the syringe to room temperature.[2]

Do not attach the 30G injection needle to the syringe until the Vabysmo injection is ready for administration.

Jørstad et al. reported the results of an in vitro study that evaluated compounding and storing Vabysmo in pre-filled syringes, and the impact this had on the stability and bi-specific binding properties of faricimab. Vabysmo was compounded into silicone-oil-free syringes and stored in the dark at 4° for 7, 14, or 37 days. Syringes stored for 7 days were stored with either a 30G, 13 mm needle or a Luer Lock cap. Syringes stored for 14 or 37 days were all stored with a Leur Lock cap.

The protein concentration, stability and integrity, and binding capacity of faricimab to vascular endothelial growth factor A (VEGF-A) and angiopoietin-2 (Ang-2) were measured.[3] The prefilled syringes were not assessed clinically or for sterility and microbiological safety. Withdrawal and storage of Vabysmo in syringes for up to 37 days was not found to impair the stability or binding properties of faricimab.

Taschauer et al. evaluated the chemical stability, physical stability, and sterility of faricimab after compounding into silicone oil-free and silicone oil-containing polypropylene syringes under aseptic clean room conditions.[4] Samples were stored at 2°C to 8°C for up to 28 days and analysed via size exclusion chromatography, dynamic light scattering, and grating-coupled interferometry. No significant differences in VEGF and Ang-2 binding affinity were found after 28 days compared to control, and the formulation maintained a stable pH of 5.5. All samples remained free of aerobic and anaerobic bacteria with endotoxin levels below 2.5 EU/mL.

1. Roche Internal Regulatory Report (Vabysmo CDS 7.0).
2. Roche Internal Technical Report (CMC 386823).
3. Jørstad ØK, Foss S, Gjølberg TT, et al. Pharmaceutical compounding and storage of faricimab in a syringe for intravitreal injection do not impair stability and bi-specific binding properties. Int J Retina Vitr. 2023;9(1):65. doi:10.1186/s40942-023-00507-3
4. Taschauer A, Sedivy A, Egger D, et al. Faricimab maintains substance integrity and sterility after compounding and storage in two different polypropylene syringe types. Eye. 2025;39(5):943-950. doi:10.1038/s41433-024-03511-5