The following transcript has been edited for clarity.
Hi, everyone. My name is Dilsher S. Dhoot, MD, FASRS. I'm here in Montreal for ASRS 2026, and I have the pleasure today of presenting the top-line data from the SOL-1 trial.
This is a unique superiority study in which treatment-naïve patients were randomized in a 1:1 fashion to OTX-TKI (Axpaxli; Ocular Therapeutix) vs aflibercept (Eylea; Regeneron). Patients first received 2 loading doses of aflibercept at -8 and -4 weeks. At randomization, patients were eligible only if they had gained at least 10 letters or had 20/20 vision. Patients were then followed for 36 weeks, and the primary endpoint was maintenance of vision, defined as less than a 15-letter loss.
In this trial, at randomization patients had excellent vision, with a mean visual acuity of 80 letters.
In terms of the top-line data, the primary endpoint was met with high statistical significance (P=.0006), with 74% of patients in the OTX-TKI arm maintaining vision compared with 56% of patients in the aflibercept arm.
At 52 weeks, those differences were maintained. We saw 66% vs 44% of patients maintaining vision in the OTX-TKI and aflibercept arms, respectively.
In terms of the need for rescue treatment, Kaplan-Meier analysis showed that 30% of patients in the OTX-TKI arm required rescue by week 52. The same proportion in the aflibercept arm occurred by week 28—a full 24 weeks earlier.
Regarding mean visual acuity and central subfield thickness, we saw maintenance throughout the 36 weeks in the OTX-TKI arm. We also saw fluid stability, with a 30-nL difference over the course of 36 weeks in the OTX-TKI arm compared with 60 nL in the aflibercept arm.
Most importantly, OTX-TKI was seen to be safe and well tolerated. Common adverse events were similar to what we expect for intravitreal injections. We did see vitreous floaters. These floaters were not related to intraocular inflammation (IOI) and coincided with hydrogel reabsorption.
Regarding IOI, there were 9 cases in 7 patients. All were mild to moderate and resolved. There were no cases of retinal vasculitis—occlusive or nonocclusive—or endophthalmitis.
We’re excited to see this program continue, and thank you all for listening. RP