RWC 2024: Week 52 safety and efficacy data from the US phase 1 trial of OTX-TKI

Dilsher S. Dhoot, MD, shared details about the Week 52 safety and efficacy data from the US phase 1 clinical trial of sustained-release axitinib hydrogel implant (OTX-TKI) for neovascular age-related macular degeneration at the 2024 Retina World Congress meeting in Fort Lauderdale, Florida.

Video Transcript:

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

Dilsher S. Dhoot, MD:

Dilsher Dhoot with California Retina Consultants Santa Barbara, Retina Consultants of America. I have the pleasure of being at Retina World Congress 2024 in Fort Lauderdale, Florida. At this meeting, I'm presenting data on AXPAXLI, 52-week data in patients with neovascular macular degeneration. AXPAXLI, also known as OTX-TKI, is a combination of a hydrogel and axitinib. Axitinib is a potent tyrosine kinase inhibitor that blocks VEGF from an intracellular pathway. In this trial, they took patients with previously treated neovascular age-related macular degeneration that were well controlled an anti-VEGF therapy, and they randomized them to 2 arms and a 3 to 1 fashion. First arm was AXPAXLI, which was dosed at baseline, then a single aflibercept injection was given at month 1. Patients then received sham injections every 8 weeks thereafter. The second arm was aflibercept arm, which received, those patients who received dosing every 8 weeks. All patients were followed for 52 weeks, and they were standard rescue criteria, in particular visual acuity and OCT parameters, which if met, patients could be rescued. In this trial, the safety data revealed that AXPAXLI was generally well tolerated with no new safety signals that were unexpected. One patient did develop endophthalmitis in the AXPAXLI group, however, this was following the 1 month aflibercept injection and not related to the AXPAXLI. The efficacy data, specifically the durability data, was quite impressive. Up to 12 months 60% of patients were rescue free. In the trial, there was an 89% reduction in injection burden in the AXPAXLI group. Based on the results of this trial. The phase three SOL-1 trial has begun recruiting, and we look forward to seeing the results of this trial in patients with treatment-naive neovascular macular degeneration.