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Hi, this is CME on ReachMD, and I’m Dr. Davinder Grover. We’re going to talk today about the iDose implant – the iDose TR. Now this is an intraocular implant in the late stages of development that’s providing kind of continuous drug delivery for patients with glaucoma. And let’s look at this clinical data and its potential uses.
So as you know, the iDose TR is currently under FDA review. It’s an implantable device that slowly elutes travoprost, and it’s held into the angle in the Schlemm’s canal through the trabecular meshwork with a specific implant. And it’s truly designed to help improve compliance and adherence and really minimize the side effects of topical therapy.
There were 2 pivotal trials, that are not yet published, that were showing noninferiority to timolol twice a day. Now the mean IOP [intraocular pressure] reduction – the mean diurnal IOP reduction – was somewhere in between 6-8 mmHg, depending on the time of day. These studies had about 1,150 subjects that were randomized to both of the phase 3 trials, and the mean washed-out IOP at baseline was 24 mmHg. 81% of these study eyes had primary open-angle glaucoma, where 19% had ocular hypertension. 67% of the randomized subjects were on at least 1 antiglaucoma medication, whereas 23% of these study eyes were on 2 or more. Now at 12 months when you look at the phase 2B and the phase 3 trial, there’s somewhere between 92% and 93% of patients were well controlled on the same or fewer medications. And at 24 months, 72% of eyes were controlled on the same or fewer medications compared to baseline. At 36 months, 69% were controlled, and interestingly, at 12 months, 81% of eyes were free of all glaucoma drops.
Now at 1 year for the phase 3 and at 3 years for the phase 2B, there were really no safety concerns. There was no periorbitopathy that we typically see with prostaglandins, no significant endothelial cell loss, no change in iris color. Now, this platform can be implanted and exchanged, and there was a subset of patients that had that performed without any safety concerns or endothelial cell health concerns. Now the majority of this study was done in the operating room, but the company did have a small group of patients that had this performed in the minor procedure room in the office without, again, any safety concerns. I don’t think that’s the major goal, but that is something – it’s an option to be had.
So the take-home point, really, is that the iDose is a potential revolution in interventional glaucoma, and the results on safety and efficacy are very promising, and this is really just the beginning of the sustained-release technology revolution and evolution of this technology. And I think the future is going to be very bright for this technology, and we’re going to continue to see more and more innovations in this space.
Thank you again for tuning in. I’m Davinder Grover, and this has been CME on ReachMD.
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