ASRS 2024: 72-Week results from the Phase 3 BALATON and COMINO trials

The American Society of Retina Specialists (ASRS) headed to Stockholm, Sweden for its 2024 meeting. Ahead of this year's ASRS meeting, Assistant Managing Editor of Ophthalmology Times and Modern Retina Sydney M. Crago, sat down with Carl J. Danzig, MD, of the Rand Eye Institute, Deerfield Beach, Florida. He spoke about his presentation on the efficacy, safety, and durability of faricimab in macular oedema due to retinal vein occlusion.

Editor's note: This transcript has been lightly edited for clarity.

Sydney M. Crago:

Hi, I'm Sydney Crago here with Modern Retina, and I'm here today with Dr. Carl Danzig of the Rand Eye Institute to talk a little bit about his presentation at ASRS 2024. Dr Danzig?

Carl J. Danzig, MD:

Thank you Sydney. I really appreciate being here. I'm going to be talking about the efficacy, safety and durability of faricimab in macular oedema due to retinal vein occlusion, the 72-week results from the phase 3 BALATON and COMINO trials. Now in these trials all patients were treatment-naive with macular oedema for BRVO, BALATON, or CRVO, COMINO trials. Patients were randomised 1 to 1 into 6 treatments of faricimab every 4 weeks, or 6 treatments of EYLEA 2 mg every 4 weeks until a primary endpoint at week 24.

My presentation is going to discuss after the primary endpoint where all patients were receiving faricimab in a treat-and-extend fashion. And what we saw in the trial was at the BCVA gains at week 24 were maintained through week 72, and the CST reduction that we saw by week 24 was also maintained, and more than 45% of patients on Q-12 week faricimab dosing it week 68 were noted across both trials. Faricimab was well-tolerated with no change in safety profile.

SC:

Can you talk a little bit about the setup and the number of participants in this trial?

CD:

In the BALATON trial, there were 553 patients, COMINO 729 [patients]. So pretty robust numbers of patients for an RVO trial. And the patients all had to be 18 years or older with a BCVA of 73 to 19 letters to enter the trial. So that's about 20/40 to 20/400. And even if patients had an ischemic RVO, they were also included with the primary endpoint at week 24.

Now, baseline characteristics: What we saw on BALATON, the mean BCVA entrance was about 57 letters and in COMINO 50. The CST thickness was 558 in the BRVO, BALATON trial and about 712 mean thickness, central subfield thickness, in the COMINO CRVO trial.

SC:

What would the next steps with these outcomes be, knowing what we know now?

CD:

What we saw at week 24 was that faricimab was not inferior to aflibercept and met its primary endpoint. But there was a pre-specified analysis looking at macular leakage on fluorescein angiography, and there was a systemically significant decrease of, or absence of, macular leakage in the faricimab arms at week 24 compared to 2 mg aflibercept.