Ocular Therapeutix reaffirms year-end AXPAXLI filing, with cash expected to last into 2028

Ocular Therapeutix said it has cash of $530.6m, which it expects to cover its costs into 2028. It reported the figure on 9 November 2026 with third-quarter results, alongside an update on its plan to seek US approval of AXPAXLI (OTX-TKI) for wet age-related macular degeneration.

The company still intends to submit a new drug application to the US Food and Drug Administration in the fourth quarter of 2026, using the 505(b)(2) route. It says a meeting with the agency in September did not change that plan. The company did not say what the FDA said on specific points, and the facts available do not show whether the agency has agreed to the changes to the SOL-R trial.

The main change is in SOL-R. The primary endpoint has moved from Week 56 to Week 40. According to the company, the aim is for every participant to complete the primary efficacy visit before the interim Week 52 safety analysis. That safety analysis is to be included in the NDA.

For context, 505(b)(2) is a US pathway that lets a sponsor rely partly on data it did not generate itself, such as published literature or earlier FDA findings for an approved product, alongside its own studies.

Ocular Therapeutix gave no pricing, launch-timing or revenue guidance in the material available.