Transcript
Announcer:
You’re listening to Eye on Ocular Health on ReachMD, and this episode is part of our "Clinical Minute" series. Here’s your host, Dr. Neda Shamie.
Dr. Shamie:
In this "Clinical Minute," we'll be discussing a randomized 20-month multicenter masked parallel-group phase 3 trial that evaluated the IOP-lowering efficacy and safety of 10 and 15-microgram bimatoprost implants in patients with open-angle glaucoma or ocular hypertension. Dr. Jason Bacharach is here to discuss the findings.
Jason, thank you so much for being here. I really appreciate you taking time to discuss your paper with us and really sharing some pearls you found and how it can impact our clinical practice.
Dr. Bacharach:
Thank you for moderating, and BMC for putting this on. This is a great way to discuss peer-reviewed literature. I’ll just give it a high-level overview. ARTEMIS 2 was really a follow-up to ARTEMIS 1. And as you know, and our colleagues know, you need two different studies to get approval. And this is really the first study and the first big innovation in GAPs therapy, Guided Administration of Pharmaceuticals, bimatoprost implants were approved, of course. And this was one of the corroborating studies towards approval. And it was a big study, it was a multicenter study. I think the take-home would be, number one, read the paper. But number two and three would be efficacy and safety.
Efficacy, it was really a noninferiority study to timolol 0.5% BID. So you know, one implant versus timolol. And that's just the way the FDA wants the studies. And the bottom line is it met all its endpoints. And in fact, in some subanalyses, as you might expect, it was, you know, superior but the bottom line was it was non-inferior to timolol BID at every timepoint, assessed over the efficacy phase, which was 12 weeks.
And then the second take-home would be safety, right? Because this is the first approved intracameral implant that delivers bimatoprost over time, and the safety was excellent. The two biggies for safety would be, obviously, the corneal endothelium. And right now, it's approved for one implant, and basically, the corneal endothelial cell loss was negligible with one implant.
And the other I think would be, do you ever have to remove these things? And in the study, really, the only time they were removed, and there were only a couple removals, were because the implant wasn't in the right position. The doctors were just learning how to place it, one ended up kind of in the cornea in the stroma, and it was removed. But really none of them had to be removed because of corneal endothelial cell loss.
So take-home, it’s a really important new tool for us in our clinical management of glaucoma patients, and this was a robust study demonstrating safety and efficacy.
Dr. Shamie:
And you know, I found your study to be really helpful and really engaging in bringing this to our practice because patients as you know with glaucoma, noncompliance is a big issue in progressive glaucoma and nerve damage, and being able to do an implant, really take away that variable of patient compliance as far as pressure control is really a fantastic option and alternative for patients.
Thank you so much for your contribution and for your help in understanding how this can add value to our practice.
Dr. Bacharach:
Thank you for inviting me.
Dr. Shamie:
Thank you.
Announcer:
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