"Vabysmo PFS shifts the retinal disease treatment persistence·efficiency"

Designed to inhibit two signaling pathways…advanced strategy of ensuring vascular safety

Improved procedural efficiency with its new formulation…has brought changes to clinical practices

"The key to retinal disease treatment is not just in simple vision improvement, but in how stably and long-term the disease can be managed."

As retinal disease treatment shifts from a short-term effect-centered approach to a long-term management strategy, the introduction of pre-filled syringe (PFS) formulations is shifting the practices.

In particular, the 'Vabysmo (faricimab)' PFS formulation, launched as a reimbursed drug on the 1st of this month, is expected to lead to changes in treatment persistence and the clinical environment, including extended dosing intervals and improved procedural efficiency.

Director Soon Il Choi of Nune Eye Hospital

Director Soon Il Choi of Nune Eye Hospital recently met with DailyPharm to highlight these changes, assessing that the retinal disease treatment paradigm is being reorganized around long-term management.

At the center of this change are dual-mechanism therapies. Until now, treatments for wet age-related macular degeneration (nAMD) and diabetic macular edema (DME) were dominated by single-mechanism therapies that inhibit only VEGF.

Before the emergence of high-dose formulations, the patient burden was significant, as dosing intervals were limited to about 2 months and required repeated direct intravitreal injections.

Vabysmo is a bispecific antibody that simultaneously inhibits vascular endothelial growth factor (VEGF)-A and angiopoietin-2 (Ang-2), offering a differentiated approach compared to existing treatments. While VEGF-A is a key factor in angiogenesis, Ang-2 is known to promote vascular instability and leakage.

Choi explained, "Blocking both pathways can contribute to maintaining blood vessels in a more stable state, going beyond simply inhibiting blood vessel formation."

This mechanistic difference is highly likely to lead to improvements in anatomical indicators in clinical practice. Experts expect faster, more stable changes in reducing retinal fluid or normalizing macular thickness, which can lead to extended dosing intervals and sustained treatment persistence. The efficacy of Vabysmo has been confirmed in various clinical trials and real-world data.

Choi stated, "Since the vision improvement effects of existing treatments have already reached a certain level, the perceived difference may be limited," and added, "How quickly and stably the retina maintains a dry state is a key factor determining long-term prognosis."

Choi suggested that Vabysmo could be more actively considered for: ▲patients who relapse even with a slight increase in treatment intervals ▲patients with insufficient response to existing agents ▲patients with high retinal fluid or high volatility; ▲patients with repeated findings suggestive of vascular instability ▲patients who could previously maintain relatively long intervals but are seeing a shortening of the drug's duration of effect.

Choi analyzed, "The advantages of Vabysmo can be expected in clinical situations requiring dual-pathway mechanisms, such as when stable disease control is needed. It can also be considered for patients with high intraretinal or subretinal fluid, high volatility, or those with concerns related to inflammation or fibrosis."

As the central axis of treatment shifts from vascular inhibition to vascular stabilization, another change is simultaneously underway in the clinical environment: formulation changes.

"PFS formulation, significance in terms of procedure standardization and infection control"

The Vabysmo PFS formulation, reimbursed since the 1st of this month, is evaluated as an element that changes the clinical process itself beyond just improving convenience.

The existing vial formulation requires several steps, such as drawing the medication into a syringe, changing the needle, and removing air. The PFS is pre-filled with the medication and can be used immediately after opening.

Choi emphasized, "Since an intravitreal injection is a procedure where medication is administered directly into the eye, even minor contamination can lead to serious complications. Reducing the preparation process is a very important change in lowering the risk of infection."

According to Choi, although complications such as endophthalmitis do not occur frequently, prevention is critical because they can have a fatal impact on vision when they do occur. In this regard, simplifying the preparation process is meaningful for ensuring safety beyond mere convenience.

In high-volume practices, this difference plays an even larger role. In ophthalmology clinics, tens of thousands of intravitreal injections are performed annually, making it crucial to minimize variables that may arise during repeated preparation steps.

Choi stated, "Intravitreal injection is a frequently performed procedure. In our hospital, about 20,000 intravitreal injections are performed annually. In an environment with a high number of procedures, the effect of reducing a single step leads to system stability, not just saved time."

Choi added, "Looking at overseas cases, there are reports that about 85% switched to PFS within about two months after the PFS formulation was released. If the reimbursement criteria are the same and there are no special restrictions on supply, most will likely switch to the PFS formulation."

The PFS formulation also affects the actual procedural process.

The Vabysmo PFS features an extra-thin-wall needle to deliver a higher flow rate at the same pressure. The injection process can be carried out more smoothly and quickly.

Choi mentioned, "For elderly patients, it is not easy to keep the eye fixed during the procedure, so it is important that the injection process is fast and smooth. These factors affect the actual patient experience."

Another characteristic of the Vabysmo PFS is that it comes with a filter needle. This structure filters out fine particles and contaminants, simultaneously increasing procedural precision and safety. This needle consists of a dedicated filter needle approved by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA).

Choi added, "Other products do not include a needle, but Vabysmo includes the needle in the product package. Maintaining consistent needle quality is a very important factor for medical staff," and added, "It can provide a consistent procedural environment in terms of handling and stability."

This mechanistic evolution and formulation improvement ultimately converge in one direction: the treatment persistence.

Macular degeneration and diabetic macular edema are diseases that must be managed over years or even decades. According to the Health Insurance Review and Assessment Service (HIRA), the number of patients with macular degeneration in Korea increased by more than 150% over the past five years, from about 200,000 in 2020 to about 560,000 in 2024.

In this process, the treatment interval, procedural burden, and frequency of hospital visits are key variables determining patient compliance. Currently, Vabysmo has extended the dosing interval up to a maximum of 16 weeks. Choi believes this is highly significant because it can substantially reduce patients' long-term treatment burden.

Choi said, "From the patient's perspective, receiving an injection directly into the eye is a significant psychological burden. Because this treatment must be repeated for a long time, it is important to determine whether the frequency of hospital visits and injections can be reduced. Receiving treatment every month versus every three months is a completely different experience for a patient. This difference determines whether long-term treatment is maintained."

In conclusion, Choi emphasized, "For some treatments, inflammation issues can pose a clinical burden regardless of efficacy. Vabysmo is an option that can be used with relative peace of mind regarding safety and efficacy. In cases where preserving vision in one eye is critical, such as 'last eye' patients, safety is even more important than treatment effect, and Vabysmo can be a reliable treatment option in both aspects.