Ocular Therapeutix announced plans to submit a new drug application (NDA) for Axpaxli (OTX-TKI) for neovascular age-related macular degeneration (nAMD) in the fourth quarter of 2026, following discussions with the US Food and Drug Administration (FDA) that the company said support a filing based primarily on data from the phase 3 SOL-1 trial.
The company said the planned submission will include efficacy and safety data from SOL-1 along with interim safety data from the ongoing SOL-R trial. Efficacy results from SOL-R will not be included in the NDA package or subsequent review process.
According to Ocular, the FDA indicated during a May 2026 Type C meeting that it would review an application based on a single adequate and well-controlled clinical trial supported by confirmatory evidence. In SOL-1, Axpaxli met its primary endpoint and demonstrated superiority to aflibercept 2 mg (Eylea; Regeneron) at week 36 (P=.0006). The company also reported statistically significant results across all 6 prespecified sensitivity analyses and the first 3 of 5 hierarchically controlled secondary endpoints.
To satisfy safety exposure requirements, Ocular plans to conduct an interim analysis of SOL-R in the fourth quarter of 2026. The company expects the combined safety dataset from SOL-1 and SOL-R to include more than 300 patients with at least 1 year of treatment exposure.
The revised regulatory strategy has prompted changes to the SOL-R trial. Rather than serving as a confirmatory efficacy study for the NDA, SOL-R will continue in a masked fashion through week 96 to evaluate additional secondary endpoints. These include superiority to aflibercept 8 mg (Eylea HD; Regeneron) in mean change in best-corrected visual acuity (BCVA) and assessments of fibrosis and atrophy relative to aflibercept 2 mg. Topline SOL-R results are now expected in the first quarter of 2028.
Ocular also plans to hold a pre-NDA meeting with the FDA in the third quarter of 2026 before submitting a complete application later that year. If approved, the company said Axpaxli could become commercially available in 2027. RP