The following transcript has been edited for clarity.
Hello everybody. My name is Patricio G. Schlottmann, MD. I'm a retina specialist from Buenos Aires, Argentina. Here we are in Denver at the 2026 ARVO meeting and I have just presented the results of the SOL-1 study.
The SOL-1 study compares the use of OTX-TKI (Axpaxli; Ocular Therapeutix), which is a tyrosine kinase inhibitor, compared to the use of aflibercept 2 mg (Eylea; Regeneron) after 2 loading injections of aflibercept. This study is basically designed to show the data that is needed for the approval, and therefore was done according to the guidelines of 2023 from the US Food and Drug Administration (FDA). This means it’s a difficult-to-interpret study, because it is a sort of a survival study. Patients will contribute data for vision and anatomy at every visit until they hit the point of being rescued. Once they are rescued, they stop contributing data. So the way of better explaining the data to the attendees to the presentation was to construct some Kaplan-Meier survival curves, which fits perfectly for the type of study that we’re doing.
What we found there is that if you look at setting a number of patients that you will accept in your normal clinic, like 30% of your patients needing the first rescue injection, and we compare the 2 treatments according to different timelines, we found that those patients that were treated with aflibercept, they hit the mark of reaching 30% of the first rescue injection at the time point of 28 weeks. The patients that were treated with OTX-TKI reached that same mark by 52 weeks. That is a 6-month difference—and this 6-month difference is exactly what we're looking for to present a treatment that shows that it has more durability than the typical treatments that we're using at the moment.
So, the SOL-1 results basically show that OTX-TKI is well tolerated, very safe, leaves the anatomy of the eye very stable, and we have proven unmatched ability of about 6 to 12 months in the majority of the patients. Thank you. RP
