Axitinib is a small-molecule tyrosine kinase inhibitor developed for oncology and marketed as Inlyta. It is approved for renal cell carcinoma and is used as an oral targeted anti-cancer therapy. The medicine is prescription-only.
Axpaxli (OTX-TKI) met its primary endpoint in the SOL-1 Phase 3 trial, demonstrating superiority over aflibercept in preserving visual acuity in wet AMD patients at week 36. A single injection of the intravitreal hydrogel led to higher rescue-free rates and better fluid control, supporting potential for reduced treatment burden. Ocular Therapeutix plans to submit a New Drug Application to the FDA.
Ocular Therapeutix stock surged 30% in premarket trading as the company prepared to release topline Phase 3 data for AXPAXLI in wet AMD. The SOL-1 trial results will be presented at the Macula Society meeting later in February. The company plans to file for FDA approval using one-year data if results are favorable.
A 12-week supervised remote exercise program for patients with metastatic renal cell carcinoma undergoing immunotherapy showed significant improvements in health-related quality of life, fatigue, and symptom burden in a case series of 19 patients.
Ocular Therapeutix announced positive topline results from the SOL-1 Phase 3 superiority trial of AXPAXLI for wet age-related macular degeneration, meeting its primary endpoint with statistically significant improvements in vision outcomes compared to aflibercept.
Ocular Therapeutix's Axpaxli met its primary endpoint in the SOL-1 Phase 3 trial, showing superior vision maintenance compared to aflibercept in wet AMD patients. The company plans to pursue FDA approval based on the results.
Ocular Therapeutix announced positive topline results from SOL-1, its Phase 3 superiority trial of AXPAXLI for wet age-related macular degeneration, meeting primary and durability endpoints with high statistical significance.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
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TACTIC-RCC: Toripalimab Plus Axitinib Induction With Selective Deferred Cytoreductive Nephrectomy in TLS-Positive Advanced Clear Cell Renal Cell Carcinoma |
NOT_YET_RECRUITING | PHASE2 |
| NCT07630363 |
PTC-Guided Atorvastatin Plus Axitinib and Toripalimab in Advanced RCC |
NOT_YET_RECRUITING | PHASE1/PHASE2 |
| NCT07500831 |
Fasting-Mimicking Diet Combined With IO-TKI Combination Therapy in Patients With Metastatic Renal Cell Carcinoma |
NOT_YET_RECRUITING | NA |
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An Open-label, Randomized Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of the Combination Therapy of SLC-3010 and Axitinib Compared to Axitinib Monotherapy as a Second-line Treatment for Locally Advanced or Metastatic Clear Cell Renal Cell Carcinoma |
RECRUITING | PHASE2 |
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Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer |
RECRUITING | PHASE3 |
| NCT07227415 |
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RECRUITING | PHASE2 |
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RECRUITING | PHASE2 |
| NCT06860386 |
Study of Adaptive Immunotherapy With VEGFR-TKI in Patients With Advanced RCC |
SUSPENDED | PHASE2 |
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RECRUITING | PHASE2 |
