New long-term data for Roche’s Vabysmo show sustained retinal drying and vision improvements in retinal vein occlusion

(Image credit: AdobeStock/Nelson Hernández che)

Roche unveiled new 72-week data from two global Phase III studies, BALATON (NCT04740905) and COMINO (NCT04740931), evaluating faricimab (Vabysmo) in macular edema due to branch and central retinal vein occlusion (BRVO and CRVO).

According to a Roche news release,¹ available RVO treatments are typically given every 1 to 2 months, the data showed nearly 60% of people receiving Vabysmo in BALATON and up to 48% of people in COMINO were able to extend their treatment intervals to three or four months apart.^2,3,4,5 In addition, patients in the studies maintained vision gains and robust retinal drying achieved in the first 24 weeks of the studies for more than one year.

The company noted in the news release that retinal drying is a key clinical measure as swelling from excess fluid in the back of the eye has been associated with distorted and blurred vision.⁵ In both studies, faricimab was well tolerated and the safety profile was consistent with previous studies.

Levi Garraway, MD, PhD, Roche’s chief medical officer and Head of Global Product Development, highlighted the results.

“This is the first time that vision and anatomical improvements have been maintained for more than a year in global Phase III studies for both branch and central retinal vein occlusion,” Garraway said in the news release. “These long-term results build on the strong clinical and real-world data reinforcing Vabysmo as an effective treatment option for people affected by retinal conditions that can cause vision loss.”

The company noted that results will be presented virtually on February 3, 2024, at Angiogenesis, Exudation, and Degeneration 2024, organized by Bascom Palmer Eye Institute.

Ramin Tadayoni, MD, PhD, head of ophthalmology at the Cité University in Paris, France, and president of EURETINA, will be presenting the data at Angiogenesis.

“The sustained vision improvements and retinal drying seen up to 72 weeks reaffirm Vabysmo as an effective treatment for retinal vein occlusion,” Tadayoni said in the news release. “More treatment options are needed to better serve people living with this condition, and these data show Vabysmo can potentially improve outcomes while reducing the number of clinic visits needed.”

Roche noted in the news release that each study evaluated the average change in best-corrected visual acuity (BCVA) score (the best distance vision a person can achieve – including with correction such as glasses – when reading letters on an eye chart) from baseline. The studies also tracked the swelling in the back of the eye due to retinal fluid, as measured by central subfield thickness (CST). Reductions in CST indicate improvement. Overall, results showed the vision improvements and reductions in retinal fluid achieved in the first 24 weeks of the studies were maintained up to 72 weeks.¹

Results for BALATON:

• Vision gains: At 72 weeks, people receiving Vabysmo as a first-line treatment gained 18.1 letters on the eye chart, while people switched from aflibercept to Vabysmo gained 18.8 letters. During the first 24 weeks, vision gains were +16.8 eye chart letters in people receiving Vabysmo and +17.5 letters in people receiving aflibercept.
• Retinal drying: At 72 weeks, people receiving Vabysmo as a first-line treatment saw a 310.9 µm reduction in retinal swelling, as measured by CST, while those switched from aflibercept to Vabysmo saw a reduction in CST of 307 µm. During the first 24 weeks of the study, CST reductions were 314.5 µm in people receiving Vabysmo and 307.6 µm in people receiving aflibercept.

Results for COMINO:

• Vision gains: People receiving Vabysmo as a first-line treatment gained 16.9 eye chart letters at 72 weeks, while people switched from aflibercept to Vabysmo gained 17.1 eye chart letters. During the first 24 weeks of the study, vision gains were +16.9 eye chart letters in people receiving Vabysmo and +17.3 letters in people receiving aflibercept.
• Retinal drying: People receiving Vabysmo as a first-line treatment saw a 465.9 µm reduction in retinal swelling, as measured by CST, while those switched from aflibercept to Vabysmo saw a reduction in CST of 460.6 µm at 72 weeks. During the first 24 weeks of the study, reductions in CST were 462.3 µm in people receiving Vabysmo and 447.8 µm in people receiving aflibercept.

According to the company, faricimab is a bispecific antibody approved for the eye, designed to target and inhibit 2 signaling pathways, which are linked to a number of vision-threatening retinal conditions, by neutralizing angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A) to restore vascular stability.^7-10

The company noted in its news release that faricimab has been approved in more than 90 countries around the world for people living with neovascular or ‘wet’ age-related macular degeneration (nAMD) and diabetic macular edema (DME), with public reimbursement in over 25 markets and more than 2.5 million doses distributed globally.¹¹

Faricimab (Vabysmo) was approved by the FDA in October, 2023, for the treatment of macular edema following RVO.⁷ Furthermore, the data up to 72 weeks from the BALATON and COMINO studies have been submitted to health authorities around the world, including the European Medicines Agency, for the treatment of macular edema following RVO.

BALATON (NCT04740905) and COMINO (NCT04740931) are both randomized, multicenter, double-masked, global Phase III studies evaluating the efficacy and safety of faricimab compared to aflibercept. For the first 20 weeks, people were randomized 1:1 to receive monthly injections for six months of either faricimab (6.0 mg) or aflibercept (2.0 mg). From weeks 24 to 72, all individuals received faricimab (6.0 mg) up to every four months, using a treat-and-extend dosing regimen.^2,3

The company noted the Blanton study was conducted in 553 individuals diagnosed with branch retinal vein occlusion. The COMINO study was conducted in 729 people who had been diagnosed with central retinal or hemiretinal vein occlusion. The primary endpoint of each study was change in best-corrected visual acuity (BCVA) from baseline at 24 weeks.

According to the news release, secondary endpoints for weeks 0 to 24 of the studies included change in central subfield thickness (CST) and drying of retinal fluid, from baseline over time up to week 24. Secondary endpoints for weeks 24-72 of the studies assessed change in BCVA from baseline, change in CST from baseline and the proportion of individuals on treat-and-extend intervals.

References:

1. Ltd FHLR. New long-term data for Roche’s Vabysmo show sustained retinal drying and vision improvements in retinal vein occlusion (RVO). GlobeNewswire News Room. Published February 1, 2024. Accessed February 1, 2024. https://www.globenewswire.com/news-release/2024/02/01/2821659/0/en/New-long-term-data-for-Roche-s-Vabysmo-show-sustained-retinal-drying-and-vision-improvements-in-retinal-vein-occlusion-RVO.html

2. ‌Clinical Trials.gov. A study to evaluate the efficacy and safety of faricimab in participants with macular edema secondary to branch retinal vein occlusion (BALATON) [Internet; cited January 2024]. Available from: https://clinicaltrials.gov/ct2/show/NCT04740905.

3. Clinical Trials.gov. A study to evaluate the efficacy and safety of faricimab in participants with macular edema secondary to central retinal or hemiretinal vein occlusion (COMINO) [Internet; cited January 2024]. Available from: https://clinicaltrials.gov/ct2/show/NCT04740931.

4. U.S. Food and Drug Administration (FDA). Highlights of prescribing information, Aflibercept 2 mg. 2011. [Internet; cited January 2024]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125387s076lbl.pdf.

5. U.S. FDA. Highlights of prescribing information, Lucentis. 2006. [Internet; cited January 2024]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125156s105lbl.pdf.

6. U.S National Institutes of Health - National Eye Institute. Macular Edema. 2023. [Internet; cited January 2024.] Available from: https://www.nei.nih.gov/learn-about-eye-health/eye-conditions-and-diseases/macular-edema.

7. U.S. FDA. Highlights of prescribing information, Vabysmo. 2022. [Internet; cited January 2024]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761235s000lbl.pdf.

8. MHRA approves faricimab through international work-sharing initiative [Internet; cited January 2024]. Available from: https://www.gov.uk/government/news/mhra-approves-faricimab-through-international-work-sharing-initiative.

9. Heier JS, et al. Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for neovascular age-related macular degeneration (TENAYA and LUCERNE): two randomised, double-masked, phase III, non-inferiority trials. The Lancet. 2022;399:729-740.

10. Wykoff C, et al. Efficacy, durability, and safety of intravitreal faricimab with extended dosing up to every 16 weeks in patients with DME (YOSEMITE and RHINE): two randomised, double-masked, phase III trials. The Lancet. 2022;399:741-755.

11. Roche data on file.

12. Song P, et al. Global epidemiology of retinal vein occlusion: a systematic review and meta-analysis of prevalence, incidence, and risk factors. J Glob Health. 2019;9:010427. Song P, et al. Global epidemiology of retinal vein occlusion: a systematic review and meta-analysis of prevalence, incidence, and risk factors. J Glob Health. 2019;9:010427.

13. 13 Moorfields Eye Hospital, United Kingdom National Health Service Foundation Trust. RVO [Internet; cited January 2024]. Available from: https://www.moorfields.nhs.uk/condition/retinal-vein-occlusion.