Genentech, a member of the Roche Group, reported new 4-year data from an extension study evaluating VABYSMO (faricimab-svoa) for the treatment of diabetic macular edema (DME).
This long-term data was presented by Arshad M. Khanani, MD, director of Clinical Research at Sierra Eye Associates in Reno, Nevada, during the American Society of Retina Specialists (ASRS) 2024 Annual Meeting in Stockholm, Sweden.
First up: a rundown on VABYSMO.
Originally FDA approved in 2022, VABYSMO [va-bis-mo] is the first bispecific antibody indicated for neovascular (wet) age-related macular degeneration (AMD) and diabetic macular edema (DME)
The intravitreal-administered therapeutic has also been approved to treat macular edema following retinal vein occlusion (RVO).
And the recommended dosage?
Per the drug’s prescribing information:
- For wet AMD and DME: 6 mg (0.05 mL of 120 mg/mL solution) administered via intravitreal injection every 4 weeks (approximately every 28 ± 7 days, monthly) for the first four doses
- Followed by: Optical coherence tomography (OCT) and visual acuity (VA) evaluations 8 and 12 weeks later to determine whether to intravitreally administer a 6 mg dose on one of the following three regimens:
- Weeks 28 and 44
- Weeks 24, 36 and 48
- Weeks 20, 28, 36 and 44
- Followed by: Optical coherence tomography (OCT) and visual acuity (VA) evaluations 8 and 12 weeks later to determine whether to intravitreally administer a 6 mg dose on one of the following three regimens:
For RVO: 6 mg (0.05 mL of 120 mg/mL) dose of VABYSMO should be intravitreally administered every 4 weeks—an estimated 28 ± 7 days (monthly) for 6 months—into a single eye in a clinical setting.
Didn’t VABYSMO just receive FDA approval (again)?
Indeed—earlier this month, in fact. That was for the Vabysmo Prefilled Syringe (PFS) version of the bispecific antibody, which is indicated for all three of its previous indications: wet AMD, DME, and RVO.
Gotcha. So what’s the clinical data on it?
An extensive look at the latest clinical findings on VABYSMO for RVO, DME, and wet AMD can be found here.
The overall finding: All findings from four phase 3 trials supported the efficacy and superiority of VABYSMO in treating its target patient bases.
Now talk about this extension study.
The RHONE-X study (NCT04432831) was a multicenter, long-term extension study evaluating VABYSMO when administered to participants who previously enrolled in and completed one of two prior DME-based phase 3 studies:
- YOSEMITE (NCT03622580)
- RHINE (NCT03622593)
Details, please.
The participants: 1,479 (aged 18+).
The setup: Masked period followed for first 16 weeks, in which participants receive either:
- Faricimab (ie: VABYSMO)
- Administered intravitreally
- Sham injection
- Administered intravitreally
After Week 16: Open-label design
Note: All participants were treated on a personalized treat-and-extend regimen, per Genentech, with the time between VABYSMO treatments increased based on a patient’s retinal fluid levels and VA.
And the outcome measures?
Three key primary endpoints included:
- Development and severity of ocular adverse events (AEs)
- Measured up to 2 years
- Occurrence and severity of systemic, non-ocular AEs,
- Measured up to 2 years
- Participants with anti-drug antibodies (ADA) at baseline + incidence of ADAs during study period
- Measured from baseline up to 2 years
Its exploratory objective: to evaluate VABYSMO’s long-term efficacy.
Alrighty, now these findings.
To start: The study met all its primary endpoints, demonstrating safety data consistent with VABYSMO’S already-established safety profile in DME patients receiving treatment up to 4 years.
Go on …
By the end of 4 years, the exploratory analysis found that nearly 80% of VABYSMO-treated patients had extended their treatment intervals to every 3 or 4 months.
As a bonus: These same patients “maintained the vision improvements and sustained the drying of retinal fluid they achieved during the initial phase 3 studies [ie: the YOSEMITE and RHINE trials],” the company reported.
Did any patients achieve DME absence?
Yes, actually — over 90%, in fact.
Note: This absence of DME was defined by a central subfield thickness (CST) of less than 325 µm.
That’s pretty impressive. So what’s the significance of this?
The company reported that this extension study is the largest long-term extension dataset in DME to-date, “demonstrating consistent positive results.”
And according to Genentech Chief Medical Officer and Head of Global Product Development: “These 4-year data build on our pivotal studies and reinforce VABYSMO’s potential to become standard of care treatment for DME.”