Genentech, a member of the Roche Group, released new 72-week data from the BALATON and COMINO phase 3 clinical trials assessing the safety and efficacy of VABYSMO (faricimab-svoa) to treat macular edema as a result of branch and central retinal vein occlusion (BRVO and CRVO), respectively.
Let’s start with VABYSMO.
VABYSMO [va-bis-mo] was originally approved by the FDA in 2022 as the first bispecific antibody indicated for neovascular (wet) age-related macular degeneration (AMD) and diabetic macular edema (DME)
In October 2023, the intravitreal-administered therapeutic was also approved to treat macular edema following retinal vein occlusion (RVO).
Currently, VABYSMO is commercially available in over 90 countries.
And the recommended dosage?
Per its RVO-indicated prescribing information, a 6 mg (0.05 mL of 120 mg/mL solution) dose of VABYSMO can be intravitreally administered every 4 weeks—translating to an estimated 28 ± 7 days (monthly) for 6 months—into a single eye in a clinical setting.
Wet AMD and DME dosages can be reviewed here.
Now these phase 3 studies.
The BALATON (NCT04740905) and COMINO (NCT04740931) phase 3 studies were both global, randomized, multicenter, double masked, active comparator-controlled, parallel group studies that enrolled:
- BALATON: 553 patients with BRVO
- COMINO: 729 patients with CRVO or hemiretinal vein occlusion
In each study, patients randomly (1:1) received 6 monthly injections of VABYSMO (6.0 mg) or aflibercept (2.0 mg) for 20 weeks.
For weeks 24-72, all patients were administered VABYSMO (6.0 mg) up to every 4 months.
And what was measured?
Both trials evaluated the change in best-corrected visual acuity (BCVA) from baseline at 24 weeks using statistical analytic measurements per the BALATON and COMINO study plans.
Other endpoints included central subfield thickness (CST), where reductions could indicate improvement in macular edema.
What did prior data indicate?
Back in February 2023, Genentech reported that the primary endpoint was met in both studies, with non-inferior visual acuity gains observed for VABYSMO (compared to aflibercept).
And in October 2023 (just before its FDA approval), the company reported positive, topline, long-term data consistent with the previous findings.
So what’s this new 72-week data?
Overall, nearly 60% (BALATON) and 48% (COMINO) of participants receiving VABYSMO “were able to extend their treatment intervals to 3 or 4 months apart,” Genentech reported.
The company also stated that participants for both studies maintained vision gains and achieved “robust retinal drying in the first 24 weeks of the studies for more than 1 year.”
Let’s focus on BRVO (BATALON) first.
At 72 weeks, BALATON’S VABYSMO-receiving participants gained 18.1 eye chart letters (vs 18.8 eye chart letters for participants who switched from aflibercept to VABYSMO).
At 24 weeks, vision gains were:
- +16.8 eye chart letters (VABYSMO patients)
- +17.5 eye chart letters (Aflibercept participants)
Now CST data.
At 72 weeks, the study’s VABYSMO-receiving participants saw a CST reduction of 310.9 µm. Comparatively, those who switched from aflibercept to VABYSMO saw a 307 µm reduction in CST.
And at 24 weeks, CST reduction was:
- 314.5 µm (VABYSMO patients)
- 307.6 µm (aflibercept participants)
Now give me specifics for CRVO (COMINO).
At 72 weeks, COMINO’s VABYSMO-receiving participants gained 16.9 eye chart letters (vs 17.1 eye chart letters for participants who switched from aflibercept to VABYSMO).
At 24 weeks, vision gains were:
- +16.9 eye chart letters (VABYSMO patients)
- +17.3 eye chart letters (Aflibercept participants)
And retinal drying?
At 72 weeks, the study’s VABYSMO-receiving participants saw a CST reduction of 465.9 µm. Comparatively, those who switched from aflibercept to VABYSMO saw a 460.6 µm reduction in CST.
And a 24 weeks, CST reduction was:
- 462.3 µm (VABYSMO patients)
- 447.8 µm (aflibercept participants)
So what’s the significance of this?
According to Genentech’s CMO and Head of Global Product Development Levi Garraway, MD, PhD, “This is the first time that vision and anatomical improvements have been maintained for more than a year in global phase 3 studies for both branch and central retinal vein occlusion,” he stated.
Give me the bigger picture.
With this 72-week extension data in hand, VABYSMO could reshape the treatment landscape by potentially improving outcomes while reducing the number of follow-up visits needed for patients suffering from macular edema secondary to RVO.