Novel Drug Delivery System for the Management of Wet AMD - Episode 5
Carl Regillo, MD highlights the Port Delivery System (PDS), a new surgical implant with sustained release of anti-VEGF therapy that recently completed phase III clinical trials.
Diana Do, MD: Carl, we mentioned the need for more durable medicines, and this past year we’ve had the release of some exciting late phase data on new therapies. One of these therapies is the Port Delivery System, which is a surgical implant. Can you give us a brief summary of the data and what it promises for our patients?
Carl Regillo, MD: This is an exciting development. It’s truly something novel, something different as a way to get true sustained delivery. When I mean true sustained delivery, I’m talking let’s get 6 or more months of good anti-VEGF effect. So, what PDS, Port Delivery System, as you mentioned, is an implant. It’s a scleral-based intraocular, reservoir-like device that’s filled with a high concentration of ranibizumab, and by passive diffusion done at concentration gradient you get slow release of the drug into the vitreous cavity, and it gives you sustained release of, as the trials are showing, at least 6 months for most of our patients. It is a device that is placed in the OR [operating room], so it is surgery to the start off utilizing this approach. Then the device is refilled in the office with a special refill exchange needle. New drug is effectively put into the device right in the office; it’s a little more involved than a standard intravitreal injection to replenish the device. But the device was really performing well in our clinical trials from the early phase 2 experience.
I can briefly describe the phase 2 study. The LADDER trial was our first glimpse of how well this device was working. The end point of that trial was the time to the first refill of the device compared to gold standard monthly injections as the control arm to look at how well the device was giving an anti-VEGF effect. What the study showed is the median time to refill was 15.8 months in the high concentration arm of the study, and over 80% of patients went 6 or more months before they needed a refill. That’s what gave us that glimpse into, wow, this is giving us 6 or more months of sustained-release effect. Of course, the visual acuity results and the OCT [optical coherence tomography] results were on par, noninferior with monthly gold standard individual ranibizumab injections like the original studies. It controlled exudation as well but didn’t need to be refilled very frequently.
That launched the phase 3 Archway study. In that study, it was designed a little differently. It mandated a refill of the same device, same high concentration ranibizumab, but mandatory refills every 6 months in this 2-year clinical study with a 1-year primary end point. It showed the device once again performed really well, controlled the signs of exudation, maintained the vision gains, and controlled the exudation as measured by OCT very well through the primary end point and now to about 18 months of follow-up. That’s the latest study result. It was both noninferior and equivalent to monthly injections, so you can’t do better than that. The great news is it was refilled every 6 months, but very few patients needed any supplemental injections, less than 2% in the first 6 months, less than 5% in the second 6 months. It was giving us reliable anti-VEGF effect with very little supplemental treatment.
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Transcript Edited for Clarity