Shawn Kavoussi, MD:

Hello, I'm Sean Kavoussi from Houston, Texas, and I'm excited to be here at ASRS 2026 where I presented the phase two LUNA data for ixo-vec intravitreal gene therapy for neovascular age related macular degeneration. Patients that were enrolled and randomized into one of two doses of a single intravitreal injection, either 2E11 or 6E10 of ixo-vec, and patients were followed for a one-year primary study and then were eligible to proceed into a second year extension study. The LUNA study looked at both efficacy in terms of BCVA and central retinal thickness maintenance, as well as safety as far as what is the optimal steroid prophylaxis that would be advanced into phase three.

The results were as follows. BCVA and CST were maintained throughout the one year and the two year extension study. Four different steroid prophylaxis regimens were evaluated, including topical Durezol long taper plus or minus oral prednisone or a topical Durezol long taper plus Ozurdex and then plus or minus oral prednisone.

What they found was that topical Durezol alone, a long taper, was sufficient to prevent inflammation in these patients and a 27 week Durezol taper was advanced into the phase three pivotal studies. Rescue criteria in the LUNA study included CST increase of 75 microns or a drop of 10 letters in BCVA that was due to worsening AMD or a new macular hemorrhage. This was a very high treatment need population. In the year prior to enrollment, the patients averaged 10 intravitreal injections per year. After receiving Ixevec, there was a 90% reduction in treatment burden with an average of one annualized injection per year.

Now, when you talk about gene therapy, safety comes to the front of the mind and you want to make sure that this is both safe in addition to effective. And what the LUNA study showed was that of all the patients who received local steroid prophylaxis and the lower dose 6E10 that was advanced to the phase three studies, only two patients had one plus cell at any time point during the first year and there was no inflammation in the second year.

Overall, we're excited with the promise of intravitreal gene therapy and we're excited and eagerly await the phase three results of Artemis and Aquarius pivotal studies. Artemis has completed enrollment. Many patients are already reaching the one year primary endpoint and the Aquarius study is rapidly approaching enrollment closure.