FDA Alignment Boosts Wet AMD Treatment Path - Scorecard - MDSpire

FDA Alignment Boosts Wet AMD Treatment Path

Ocular Therapeutix plans Q4 NDA filing for AXPAXLI

  • July 7, 2026

  • 3 min

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Clinical Scorecard: FDA Alignment Boosts Wet AMD Treatment Path

At a Glance

CategoryDetail
ConditionWet Age-Related Macular Degeneration (AMD)
Key MechanismsAXPAXLI is a bioresorbable intravitreal hydrogel incorporating axitinib, a tyrosine kinase inhibitor with anti-angiogenic properties.
Target PopulationPatients with wet AMD and diabetic retinal disease.
Care SettingClinical trials and regulatory submission processes.

Key Highlights

  • Ocular Therapeutix plans to submit a New Drug Application for AXPAXLI in Q4 2026.
  • Submission based on Phase 3 SOL-1 efficacy and interim SOL-R safety data.
  • AXPAXLI could potentially reach patients in 2027 if approved.
  • A new key secondary endpoint will evaluate AXPAXLI against aflibercept at Week 96.
  • SOL-R trial will remain masked through Week 96.

Guideline-Based Recommendations

Diagnosis

    Management

      Monitoring & Follow-up

        Risks

          Patient & Prescribing Data

          Patients with wet AMD and diabetic retinal disease.

          AXPAXLI shows unmatched durability and sustained disease control.

          Clinical Best Practices

          • Engage with regulatory bodies early in the drug development process.
          • Utilize robust clinical trial data to support NDA submissions.

          Related Resources & Content

          Original Source(s)

          FDA Alignment Boosts Wet AMD Treatment Path

          • July 7, 2026

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