The following transcript has been edited for clarity.

Diana V. Do, MD: Hi, I'm Diana V. Do, MD, at Retinal Physician. Today I’m joined by my colleague and friend, Jeremy Wolfe, MD. He gave a really good update on the port delivery system with ranibizumab (Susvimo; Genentech). Can you share this information with all of our clinicians out there?

Jeremy Wolfe, MD, MS: I'd be happy to, thank you. What we talked about today was long-term fluid data in the neovascular age-related macular degeneration (nAMD) population. And it’s really interesting. Continuous therapy with the port delivery system maintains vision for 5 to 7 years and with very little dropoff compared to long-term standard-of-care studies or real-world studies and also controls the fluid amazingly well. So we see 85% of patients have no intraretinal fluid over the study. And the retinal thickness, when we look from the beginning of the study to the end of the study, is like a flat line. So we see incredible control with the port delivery system.

Dr. Do: This is very exciting long-term data. How about safety? This is a surgically implanted device—are there any long-term safety signals?

Dr. Wolfe: I think safety is super important. And at the time of approval, there was a black box warning about endophthalmitis being at a higher rate. So in this study over 8 years, it shows 2.8% ... incidence of endophthalmitis. And interestingly, we think of comparing that to injections, and we think of injection risk being very low. We’ll quote somewhere between 1 in 1,000 or 1 in 5,000. But the true risk is actually over that period of time. So it’s not one injection risk, it’s the injection risk over time. So if we compare that to 8, 10, 12 injections a year, at 12 injections a year the incidence is the same. And in this study—we’re talking about ARCHWAY, LADDER, and PORTAL—in these [earlier] studies, the risk and incidence of endophthalmitis is higher than it is currently. So we’re over 2% in these trials. In PAGODA, which is the diabetic macular edema (DME) trial for the port delivery system, the rate comes down to 1.1%.

As you can tell, I think a lot about the safety. I think a lot about the endophthalmitis, but I think that when we compare apples to apples, it’s a good comparison and a good risk.

Dr. Do: And what about the refill procedure? How often do you need to refill the reservoir?

Dr. Wolfe: Different people look at this differently. The phase 3 study was every 6 months, and I stay close to that because I believe in continuous therapy and I want to do that. But I have colleagues who go longer: 9 months, a year. In fact, in the phase 2 trial, it was a pro re nata (PRN) trial and the average time to refill was over a year; it was 15 months. So I go every 6 months, but there is some room, I think, to go longer.

Dr. Do: Thank you so much, Jeremy, for sharing this long-term data on the port delivery system. It truly is a way to deliver continuous VEGF inhibition to our patients. RP