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Ocular Therapeutix keeps Q4 NDA plan for AXPAXLI in wet AMD after pre-NDA meeting

🇺🇸 Ocular Therapeutix, Inc (OCUL) · Mon 09 Nov 2026

The company says its 505(b)(2) filing for AXPAXLI remains on track after a September FDA meeting, with the SOL-R primary endpoint moved to Week 40.

Ocular Therapeutix said on 9 November 2026 that it still plans to submit a new drug application to the US Food and Drug Administration for AXPAXLI (OTX-TKI) in wet age-related macular degeneration in the fourth quarter of 2026. The company is using the 505(b)(2) pathway and reported the update alongside its third-quarter results.

The timeline follows a pre-NDA meeting with the FDA held in September 2026. The company's summary of the outcome is that the filing plan has not changed.

One notable change concerns the SOL-R trial. Ocular Therapeutix has moved the primary endpoint from Week 56 to Week 40. The aim is for all participants to complete the primary efficacy visit before the interim Week 52 safety analysis, which the company says will be included in the NDA.

On finances, the company reported cash of $530.6 million at 30 September 2026. It expects this to fund operations into 2028.

As general context, a 505(b)(2) application is a US route that allows a sponsor to rely partly on data it did not generate itself, such as published literature or prior FDA findings for an approved product, alongside its own studies.

What it means for your team

  • Regulatory teams tracking the wet AMD field should note a Q4 2026 AXPAXLI submission, which would start the FDA review clock once the application is filed.
  • The revised SOL-R design moves the primary efficacy readout to Week 40, with Week 52 interim safety data to be included in the dossier, so the safety package will be an early reviewer focus.
  • Market-access and competitive-intelligence teams can treat the cash runway into 2028 as a sign that the company expects to fund its filing and review period.

Company's press release (SEC filing): Ocular Therapeutix, Inc ↗

Article written by VigiEye from the official source (Ocular Therapeutix, Inc). Claims are the company's own. AI-assisted; check the source before acting.

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