Jun 24, 2026 · 7 min · 7 segments
Ocular Therapeutix provides a key update on its NDA plans for wet AMD drug candidate Axpaxli; Thea US launches a first-of-its-kind eye gel for glaucoma; and there were several recent milestones…
Kendall O'ConnorHost
In our top story, during its recent Investor Day, Ocular Therapeutics' leadership announced that it reached alignment with the FDA on plans to submit a new drug application for wet AMD drug candidate axpaxli.
The plan NDA for axpaxli, which is also known as OTX-TKI, is expected to be submitted in the fourth quarter of twenty twenty-six.
The submission will be based on efficacy and safety findings from the Phase III SOL1 trial, together with interim safety data from the ongoing SOLR study.
According to Ocular, the FDA agreed that SOL1 could serve as the pivotal efficacy study supporting the application.
The company reported that SOL1 met its primary endpoint, demonstrating superiority on maintenance of vision at week thirty-six, with a P value of point zero zero zero six.
Ocular noted that the treatment effect strengthened over time and was supported by anatomical outcomes and statistically significant sensitivity analyses.
During the Investor Day event, Ocular Executive Chairman, President, and CEO Dr. Praveen Duggal discussed the significance of the FDA alignment.
And in fact, what you'll hear today is that we have complete formal and documented, and yes, I know this has been going around, but we do have FDA minutes.
We wouldn't be doing this without the minutes, obviously.
Ocular also announced plans to streamline its diabetic retinopathy development strategy by prioritizing a single global Phase III registrational study, HELIOS-3.
The trial will evaluate once-yearly axpaxli against sham treatment in patients with non-proliferative DR.
In our top story, during its recent Investor Day, Ocular Therapeutics' leadership announced that it reached alignment with the FDA on plans to submit a new drug application for wet AMD drug candidate axpaxli.
The plan NDA for axpaxli, which is also known as OTX-TKI, is expected to be submitted in the fourth quarter of twenty twenty-six.
The submission will be based on efficacy and safety findings from the Phase III SOL1 trial, together with interim safety data from the ongoing SOLR study.
According to Ocular, the FDA agreed that SOL1 could serve as the pivotal efficacy study supporting the application.
The company reported that SOL1 met its primary endpoint, demonstrating superiority on maintenance of vision at week thirty-six, with a P value of point zero zero zero six.
Ocular noted that the treatment effect strengthened over time and was supported by anatomical outcomes and statistically significant sensitivity analyses.
During the Investor Day event, Ocular Executive Chairman, President, and CEO Dr. Praveen Duggal discussed the significance of the FDA alignment.
And in fact, what you'll hear today is that we have complete formal and documented, and yes, I know this has been going around, but we do have FDA minutes.
We wouldn't be doing this without the minutes, obviously.
Ocular also announced plans to streamline its diabetic retinopathy development strategy by prioritizing a single global Phase III registrational study, HELIOS-3.
The trial will evaluate once-yearly axpaxli against sham treatment in patients with non-proliferative DR.
The rest of this transcript — segmented and speaker-labeled, so you land on the exact moment something was said
Search every transcript — by keyword, by phrase, or by meaning, across every show Radar indexes
Trends — what is surging across podcasts, measured against its own baseline
Alerts — when a name you follow appears in a newly indexed episode
No account is needed to search Radar.
