ASCRS 2023: Phase 3 trials of iDose TR, versus topical timolol

John Berdahl, MD sat down with David Hutton, Managing Editor, Ophthalmology Times®, to discuss his abstract on the Phase 3 trials of iDose TR, versus topical timolol at the ASCRS annual meeting in San Diego.

Video transcript

Editor’s note: This transcript has been edited for clarity.

David Hutton:

I'm David Hutton from Ophthalmology Times, the American Society of Cataract and Refractive Surgery is holding its annual meeting in San Diego. Joining me today is Dr. John Berdahl. He will discuss his abstract titled "Outcomes of the Prospective Randomized Controlled Multicenter Phase 3 Trials of iDose TR, Versus Topical Timolol." Thank you so much for joining us today Dr. Berdahl. Tell us about your abstract.

John Berdahl, MD:

Thanks so much, David, excited to be here. And drug delivery is coming of age and there's nothing that's more exciting than the iDose coming. And the abstract that we presented is really a culmination of three different studies. And two of them which are very large.

This is the main iDose approval study, and there's two separate studies required by the FDA each with over 500 patients, each with three arms. A fast-eluding, a slow-eluting and a timolol control arm. The goal of this study was to demonstrate safety and effectiveness, with the primary endpoint of non-inferiority to timolol.

Timolol has proved to be a formidable competitor for non-inferiority studies, and in this study, the endpoints of non-inferiority were met. The average IOP lowering in the iDose groups range from 6.6-8.5, versus 6.6-7.7 of reduction in the Timolol group. So the take home point there is, their bottom IOP lowering was every bit as good as timolol. But at a number of time points it did quite a bit better.

Eighty-one percent of the patients with the travoprost intraocular implant, were free of ocular hypotensive medications. Ninety-three percent were well-controlled on the same or fewer medications. And when you compare that to the timolol arm, only 67% of timolol patients were well-controlled on the same or fewer medications. From a safety standpoint, the safety was tremendous in line with what we've seen from things like the iStent in the past. When you look at the areas of interest within safety, conjunctival hyperemia was very low at 3%.

There were no corneal endothelial cell loss issues, no serious corneal adverse events, and nothing related to topical administration of medications that you'd see with prostaglandins like periorbital fat atrophy.

The third study in this was an exchange study, and I was an investigator in both the big study and in the exchange study. And what we showed in the exchange study is that the device could be safely removed, and a new one could be safely placed without endothelial cell loss at the 12 month time point.

So in summary, we have a drug delivery device that has met its inferiority endpoints in a very large study. That demonstrated safety at 12 months, efficacy at 3 months. And it's yet to be determined how long this device will be able to deliver drug and continue to lower IOP and it is a technology that I think is really going to bring a coming-of-age of drug delivery in glaucoma care.