ASRS 2024: First readout of the Phase 3 PAGODA trial

Carl C Awh, MD, FASRS, sat down with Hattie Hayes, Editor of Ophthalmology Times Europe, to discuss the first readout of the Phase 3 PAGODA trial at the American Society of Retina Specialists meeting held in Stockholm, Sweden.

Video Transcript:

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

Hattie Hayes:

Hi, I'm Hattie Hayes, editor of Ophthalmology Times Europe. This year, the American Society of Retina Specialists held its annual meeting in Stockholm, Sweden. Joining me today is Dr Carl Awh. He'll be speaking about his presentation, a first readout of the Phase 3 PAGODA trial, year 2 results. Thank you so much for joining me today.

Carl C. Awh, MD, FASRS:

Thank you for having me.

Hattie Hayes:

And to start, could you give me a brief overview of the port-based delivery system?

Carl C. Awh, MD, FASRS:

Yes. The port delivery system, PDS, or the commercial name is Susvimo, is a small, surgically-implanted reservoir that's filled with a highly-concentrated version of ranibizumab. We place it in the sclera, where it resides permanently. It's about the length of a grain of rice. And it holds about two one-hundredths of a CC of this concentrated drug, that is released slowly, over many, many months, into the vitreous cavity.

What we have found, and what was FDA-approved a couple of years ago, was that this controls wet macular degeneration as well as monthly injections of ranibizumab. Ideally, this supplants intravitreal injections for appropriate patients. So we've seen that, in wet macular degeneration. And what I've presented at ASRS has to do with diabetic macular edema. So the Phase 3 PAGODA trial is a registration study for using the same technology for patients with diabetic macular edema. And that study showed, at the primary endpoint of one year, that diabetic macular edema was controlled beautifully with the port delivery system. You know, similar to monthly injections of ranibizumab. And we have now shown that those same results have been maintained at 2 years from the start of the study.

Hattie Hayes:

Tell me more about how these 2-year results compared to some of the earlier findings. Is there anything that surprised you, or that your colleagues might find surprising from those year 2 results?

Carl C. Awh, MD, FASRS:

I think it's really more reassuring. It was good to see that the 1-year results were maintained to 2 years. It was also reassuring to see that the complication rate remained similar to what we've seen in the neovascular AMD studies...and year 2 of PAGODA was very similar to year 1, no unexpected, serious adverse events. So I think that these findings will make people open to the idea of using this for appropriate patients. We find that, with wet macular degeneration, many patients have really appreciated the reduction in treatment burden: not having to come monthly for injections, just having to come every 6 months for a refill exchange procedure. In diabetic retinopathy and diabetic macular edema, the patients in general are younger. Many of them are working, many of them have multiple doctor's appointments or medical appointments. So the ability to reduce their treatment burden, I think, is even more important in that younger patient population.

Hattie Hayes:

What do you think is the key takeaway for someone who's at the meeting, or who watches this video, and then goes back to their practice on Monday morning? What do you hope that those retina specialists who see your presentation take away from it?

Carl C. Awh, MD, FASRS:

Well, we have lots of great treatment options now. And that universe of options is expanding. So this is simply one that adds to that group of treatments. I think that people will come away from this understanding that, for some patients, this really is worth considering, and that for some retina specialists, the effort that it will take to learn to use this–because it's a new procedure with a surgical technique. And so that technique, although straightforward, for any skilled surgeon is still something new and different. And so we have to learn how to do it before being able to give it to patients. So I think that's always a little bit of a barrier. But in the past, that has not kept retina specialists from adopting new technologies, when there's an obvious benefit. So I think there will be a group of patients and a group of retinas specialists that find this very appealing. I think the discussion at ASRS will be very interesting because of the recent FDA approval to relaunch this device.

Hattie Hayes:

Thank you so much. I really appreciate it and I hope that our viewers appreciate getting a little sample platter of ASRS right at home.

Carl C. Awh, MD, FASRS:

Thank you for having me.