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IOP outcomes with intravitreal injection of aflibercept, 8mg and 2mg in patients with DME

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Mark Barakat, MD, sat down with Ophthalmology Times to discuss intraocular pressure outcomes with intravitreal injection of aflibercept, 8mg and 2mg in patients with diabetic macular edema through week 48 of the phase 2/3 PHOTON trial.

Mark Barakat, MD, sat down with Ophthalmology Times to discuss intraocular pressure outcomes with intravitreal injection of aflibercept, 8mg and 2mg in patients with diabetic macular edema through week 48 of the phase 2/3 PHOTON trial.

Video Transcript:

Editor's note: The below transcript has been lightly edited for clarity.

David Hutton:

I'm David Hutton of Ophthalmology Times. The Association for Research in Vision and Ophthalmology recently concluded its annual meeting, which was held this year in Seattle. At that meeting, Dr. Mark Barakat, presented intraocular pressure outcomes with intravitreal injection of aflibercept, eight milligram and two milligram in patients with diabetic macular edema through week 48 of the phase 2/3 PHOTON trial. Thank you so much for joining us today. Tell us about your presentation at the ARVO meeting.

Mark Barakat, MD:

Absolutely, thank you so much for having me. So I mean, essentially, we're very fortunate to have both two milligram aflibercept and the higher dose eight milligram aflibercept. One of the key differences is not just necessarily in duration, but it's also in terms of volume. The two milligram is .05 and the eight milligram high dose is .07. So a natural question that arises is, well does that have any deleterious impacts on intraocular pressures with with these repeated injections? So this is basically a post hoc analysis of the PHOTON trial, which looked at all these subjects in these different categories, those that were getting the two milligram, and those who were getting eight milligram at different intervals. And the question that was posed is, is there a difference. And in short, the answer is no, this was actually very well tolerated and safe. That the intraocular pressure in the eight milligram groups was pre dosing was suitable throughout the 48 weeks.

And similarly, we also looked at the fellow eyes and the fellow eyes remain stable as well whether or not those fellows receive treatment, or otherwise. And then when you actually compare the eight milligram doses to the two milligram doses, there were also very similar both in terms of changes in intraocular pressure, which were actually minute, pretty well tolerated. And also in terms of how many of these eyes, for example, eyes with with no history of glaucoma, were put on on IOP lowering drops, and those those percentages are really small, and 1 to 2% across all categories? And ultimately, the the other question is, well, did any of them meet any procedures to lower the pressure. And in short, there are a rare number of patients that received Pehrson TCS. But vanishingly small across that data set and relatively well balanced. So, the long and short of it is that, yes, we were right to have the theoretical concern about intraocular pressure. The data thus far is encouraging at week 48. And we look forward to having longer data coming out soon to week 96.

David Hutton:

How could the results of this research ultimately impact ophthalmology, from ophthalmologists to the patients they treat?

Mark Barakat, MD:

You know, you always wonder a new worry when a new agent comes out. What is the safety profile? What is the safety profile, will it be similar in the clinic as it is in the clinical trials? And while this doesn't answer real world, it does give us some assurance that this was actually well tolerated in the clinical trials. And so the the safety profile of the eight milligrams and two milligrams seemed remarkably similar. And so that's that's encouraging terms of reaching for that medication.

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