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Ixo-vec in Wet AMD: LUNA Trial
Dr. Kondapalli: Ixo-vec is an intravitreal gene therapy, and the thought is that the drug would be used for neovascular, or wet, age-related macular degeneration. Results from the LUNA phase II clinical trial were released recently.
Ixo-vec is interesting because it uses a very proprietary expression cassette, a vector capsid carrying aflibercept. And this is kind of new for us in retina where we’re not super familiar with gene therapy, although we definitely are familiar to some degree because there are certain diseases that are treated currently with gene therapy. However, Ixo-vec might be a great opportunity for us to treat a very common disease we see in the clinic, wet macular degeneration.
Ixo-vec reduced frequency of anti-VEGF injections
In the phase II LUNA trial, the investigators looked at two different doses of Ixo-vec, and participants were able to maintain visual and anatomical outcomes regardless of dose. Ixo-vec reduced the need for anti-VEGF injections. And there was a certain percentage of patients who actually remained injection-free, an outcome very similar to that in the investigators’ previous trial, which was the OPTIC trial.
In terms of injection burden, what is interesting is that there was a reduction in anti-VEGF injection rates at 26 weeks to anywhere from 90% to 94% or 68% to 85%, depending on the dose.
Safety and tolerability
Ixo-vec was generally well-tolerated. There was, however, some intraocular inflammation, which was responsive to local corticosteroids. That was another component of the trial. They looked to see if they could do any sort of preventive steroids to mitigate any significant inflammation. And they found that they prevented the inflammation with Ozurdex plus or minus a course of Durezol eye drops. The thought is that the Ozurdex plus the Durezol treatment may prevent further inflammation and may be a prophylactic regimen that may be useful for pivotal studies going forward. Oral corticosteroids, however, did not really show any incremental benefit. And, really, this phase II study looked to see which dose would be beneficial, but also which prophylactic dose, in terms of corticosteroids, can be used to prevent inflammation, which is a known side effect of this potential therapeutic intervention.
Additional Info
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