Faricimab in Retinal Vein Occlusion: 24-week results from the BALATON and COMINO Trials

Theme: Retina*
What: Retina
Part of: Retina II: Stamping out Blindness and Restoring Sight / Rétine II: Lutter contre la cécité et redonner la vue
When: 6/1/2024, 04:15 PM - 05:45 PM
Where: Room | Salle 713 AB

Abstract

Purpose:

To assess the 24-week efficacy and safety of faricimab in patients with macular edema due to retinal vein occlusion (RVO).

 

Study Design:

Phase 3, multicenter, randomized, double- masked, active comparator–controlled trials, BALATON (NCT04740905) and COMINO (NCT04740931).

 

Methods:

Anti-VEGF treatment-naïve patients with center-involving macular edema secondary to BRVO or CRVO/HRVO were enrolled in this faricimab study. From day 1 through week 20, patients received 6 monthly intravitreal injections of faricimab 6.0 mg or aflibercept 2.0 mg. After the primary endpoint at week 24, all patients crossed over to faricimab 6.0 mg in up to 16 weekly intervals based on personalized treat-and-extend based regimen. The primary endpoint was change from baseline in best-corrected visual acuity (BCVA) at week 24. Noninferiority of faricimab versus aflibercept was evaluated. Secondary endpoints through week 24 include mean change from baseline in BCVA and central subfield thickness (CST).

 

Results:

553 and 729 patients were enrolled in BALATON and COMINO, respectively. BCVA gains from

baseline at week 24 with faricimab were noninferior to aflibercept in BALATON (adjusted mean

[95.03% confidence interval] change: +16.9 letters [15.7, 18.1] vs +17.5 letters [16.3, 18.6]) and

COMINO (+16.9 letters [15.4, 18.3] vs +17.3 letters [15.9, 18.8]). CST reductions from baseline

were comparable across treatment arms. Faricimab was well tolerated through week 24, with a

safety profile comparable to aflibercept.

 

Conclusions:

Findings from BALATON/COMINO demonstrate the efficacy and safety of faricimab, a dual angiopoietin-2 and VEGF-A inhibitor, in patients with macular edema secondary to RVO.

Presenter(s)

Presenting Author: Parnian Arjmand

Additional Author(s):

Motohiro Kamei, Department of Ophthalmology, Aichi Medical University, Nagakute, Japan.

Liliana P Paris, Genentech, Inc., South San Francisco, CA, USA.

Francis Abreu, Genentech, Inc., South San Francisco, CA, USA.

Pablo Arrisi, Roche Products Ltd, Welwyn Garden City, UK.

Karen Basu, Roche Products (Ireland), Dublin, Ireland.

Zdenka Haskova, Genentech, Inc., South San Francisco, CA, USA.

Ying Liu, Genentech, Inc., South San Francisco, CA, USA.

Anne-Cecile Retiere, Roche Products Ltd, Welwyn Garden City, UK.

Jeffrey Willis Willis, Genentech, Inc., South San Francisco, CA, USA.

Aachal Korecha, Roche Products Ltd, Welwyn Garden City, UK.

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