CTS 2024: Results of AXPAXLI clinical trials presented

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Anat Loewenstein, MD, spoke with Modern Retina about her presentation of AXPAXLI trial results and upcoming trials for this potential treatment, which she gave at Clinical Trials at the Summit meeting held in Park City, Utah on June 8, 2024.

Anat Loewenstein, MD, spoke with Modern Retina about her presentation of AXPAXLI trial results and upcoming trials for this potential treatment, which she gave at Clinical Trials at the Summit meeting held in Park City, Utah on June 8, 2024.

Video Transcript:

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

Sydney M. Crago:

Hi, I'm Sydney Crago, Editor of Modern Retina, and I'm here today with Dr. Loewenstein to talk a little bit about her presentation at Clinical Trials at the Summit. Dr. Loewenstein?

Anat Loewenstein, MD:

Hello, I'm Anat Lowenstein. I am the Chair of the Division of Ophthalmology in the Tel Aviv Medical Center in Tel Aviv, Israel, and the President of the EURETINA organization. I was thrilled to attend the CTS meeting, which was a meeting full of innovations, discussions, new technologies, new drugs, all the novelties that are coming up to help us in the management of our patients. My talk was on AXPAXLI for the management of neovascular macular degeneration (AMD), and AXPAXLI is a drug which is a TKI, which binds to the intracellular geosynchronous domain and inhibits the VGF receptors from the from the inside of the cell. So, the drug, axitinib, acts intracellularly to inhibit the VGF receptors. It is mounted on an hydrogel implant, which delivers the drug and it's applied, it's inserted into the eye in an interventional administration and releases axitinib in a steady state. So the program is developed to have up to phase 3 macular degeneration and also phase 1 in diabetes. But my talk was specifically about the trials in macular degeneration. I talked about the Phase 1 United States trial in which AXPAXLI did demonstrate extended duration of action as compared to the comparator after step 2 mg. In this phase one study 60% of AXPAXLI treated subjects were rescue feel free for up to 52 weeks. So it's very, very exciting result. And something that can bring real hope for our patients and for our system. And at the same time, the mean best-corrected visual acuity and central subfoveal thickness were comparable to the standard of care, aflibercept 2 mggiven every eight weeks. The Australian phase 2 trial was different in that it dealt with naive patients. So with the naive pateints, clinically meaningful reductions in central subfield thickness were achieved very nicely. And also, when we when we looked at the the group of patients who were censored, namely only the ones that did not need rescue, then there was a very nice improvement in best corrected visual acuity. And we have many examples of patients that received AXPAXLI, and then remained supplemental injection free for a very, very long time. So very good, long duration with that. And what was exciting to see is that it was with a very good safety profile, specifically no retinal detachment, no vasculitis, it is no migration of the implant into the anterior chamber. And AXPAXLI phase 3 is now enrolling. And this study this, this phase 3 trial is going to be a multicenter double-masked, randomized parallel group trial that is going to compare AXPAXLI and aflibercept following 2 aflibercept injection. Just 1 injection, and with the primary outcome being a 36 week, the proportion of subjects to remain with stable vision. Of course, there'll be multiple secondary outcomes and, of course, very appropriate rescue and retreatment criteria. So that was my talk. It was received very well I think the retina physicians in the audience were very excited to hear about this new technology, which has which has the potential to be very long duration with very good results.

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