Ocular Therapeutix (OCUL) Chardan's 10th Annual Healthcare Conference summary

Clinical need and AXPAXLI

• First-year anti-VEGF dropout rate cited at 40%; Dugel said nearly half of patients who drop out ultimately go blind.

• AXPAXLI combines a tunable hydrogel with a TKI, aiming to sustain treatment and address vision loss associated with pulsatile injections, atrophy and fibrosis.

• SOL-1 met a superiority endpoint versus an anti-VEGF; the FDA’s single-trial approval pathway has been formalized.

Trial design and competitive landscape

• Dugel attributed trial success to patient selection and design amid substantial retinal disease variability and a lack of biomarkers.

• SOL-1 enrolled treatment-naive patients, loaded them before randomization, and used patient de-risking; SOL-R focuses on a stable patient population.

• AXPAXLI is positioned as a maintenance treatment, distinct from bolus injections; Dugel said tarcocimab competes in the bolus category, not directly with AXPAXLI.

• Dugel cited patient selection and a potentially weaker TKI as factors in EyePoint’s trial failures, while emphasizing that different trial populations and designs matter.

FDA path and timing

• FDA interactions were described as collaborative; the pre-NDA meeting took place in Q3 2026, minutes were received, and the full NDA package remained on schedule for Q4 2026.

• Dugel cited a trial p-value below 0.0006 against an FDA robustness benchmark of below 0.001 and said evidentiary standards were met for a single-trial submission.

• Dugel said it was too early to discuss an advisory committee and saw no reason for one, given the established VEGF-suppression mechanism.