Ocular Therapeutix Reports Positive Week 52 Data for Axpaxli

Ocular Therapeutix announced additional positive Week 52 data from the SOL-1 Phase 3 superiority trial of Axpaxli its investigational product candidate for the treatment of wet age-related macular degeneration. The additional post-hoc analyses, presented at the 14th Annual Vit-Buckle Society meeting, reinforce the durability, sustained disease control, and generally well-tolerated safety seen with Axpaxli in SOL-1. Achieved statistical significance in the first three of five key secondary endpoints tested in hierarchical order. In addition, six other pre-specified secondary endpoints measuring clinically significant functional and anatomic outcomes were met with statistical significance. Subjects in the Axpaxli arm had significantly lower risk in anatomic worsening from Week 8 compared to the aflibercept arm. Week 8 was chosen to give both arms adequate time from the last aflibercept injection and start at a similar reference timepoint. The median time to greater than or equal to30 uM Central Subfield Thickness increase from Week 8 was 39 weeks in the Axpaxli group and 16 weeks in the aflibercept group, a 23-week difference. An estimated hazard ratio of 0.7 indicates that, at any time from Week 8 to Week 52, subjects in the treatment group experienced a 30% lower risk of the event compared with the control group. The median time to greater than or equal to75 uM CSFT increase from Week 8 was 46 weeks in the Axpaxli group and 24 weeks in the aflibercept group, a 22-week difference. An estimated hazard ratio of 0.5 indicates that, at any time from Week 8 to Week 52, subjects in the treatment group experienced a 50% lower risk of the event compared with the control group. Visual acuity gains achieved during the loading phase were generally maintained up to Week 52 with Axpaxli across screening BCVA quartile subgroups. The magnitude of vision improvements was influenced by BCVA at screening. For example, Axpaxli subjects in the lowest vision quartile group at screening had the greatest visual gains with +11.8 ETDRS letters compared to +8.5 letters in the aflibercept arm at Week 52. The mean vision at screening in this arm is similar to baseline BCVA in prior wet AMD studies. In comparison, subjects in the best vision quartile at screening had essentially no change in vision at Week 52 as they started with almost 20/20 vision. Observed difference for change in BCVA from baseline at Week 24 in the rescue-free subjects was -1.9 ETDRS letters in the Axpaxli arm vs. -2.6 letters in the aflibercept arm. Of note, 81% of the Axpaxli subjects were rescue-free at Week 24. At Week 36, 75% of Axpaxli subjects remained rescue-free and lost less than1 additional letter from Week 24. For all Axpaxli subjects with a vitreous floater adverse event reported, drug particles are no longer visible. Further analysis continues to illustrate the appearance of floaters corresponds closely to expected hydrogel bioresorption and drug elution without adversely affecting vision.