AXPAXLI (OTX-TKI) - (SOL-R)

June 17, 2026: Ocular Therapeutix, Inc. (NASDAQ: OCUL) outlined FDA-aligned regulatory plans for AXPAXLI (OTX-TKI) in wet age-related macular degeneration (wet AMD) following a May 2026 Type C meeting. The company plans to submit an NDA in 4Q 2026 under the 505(b)(2) pathway, based on SOL-1 Week 52 efficacy/safety plus an interim SOL-R safety analysis; SOL-R efficacy data will no longer be included in the NDA plan. To meet FDA safety exposure expectations (guidance cited as ≥300 patients with ≥1 year treatment), Ocular will conduct the SOL-R interim safety analysis in 4Q 2026 to exceed 300 patients aggregated across SOL-1 and SOL-R (SOL-1 includes 170 AXPAXLI-treated subjects). A pre-NDA meeting is planned for 3Q 2026, and Year 2 SOL-1 safety is planned for submission as a 120-day safety update post-NDA.

SOL-1 (Phase 3, SPA): primary endpoint met—74.1% maintained vision at Week 36 vs aflibercept 2 mg; risk difference 17.5%, p=0.0006. Key secondary at Week 52 met—65.9% maintained vision; risk difference 21.1%, p<0.0001.

SOL-R (Phase 3): remains masked through Week 96; topline now expected 1Q 2028. Primary endpoint (unchanged) is non-inferiority in mean BCVA change vs aflibercept 2 mg at Week 56. New key secondary endpoint will assess superiority in mean BCVA change vs aflibercept 8 mg at Week 96; prevention of fibrosis/atrophy vs aflibercept 2 mg at Week 96 will also be evaluated.

Diabetic retinopathy: program streamlined to prioritize single registrational Phase 3 HELIOS-3 (NPDR) evaluating Q12M AXPAXLI vs sham; primary endpoint is ordinal ≥2-step DRSS change at Week 56.