Clinical Trial Wins: New Data In Ophthalmology for wAMD

The week we've had Eyes on the Ocular Therapeutix phase 3 SOL-1 data showing superiority over Eylea in wet AMD. The trial showed improved visual acuity preservation, The program could introduce the first tyrosine kinase inhibitor therapy for wet AMD however, investors reacted cautiously to the news.

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Ocular Therapeutix Reports Phase 3 Victory in wAMD

Ocular Therapeutix announced positive results from its SOL-1 phase 3 trial evaluating Axpaxli, a hydrogel formulation of Pfizer’s former kidney cancer drug Inlyta (axitinib) in wAMD.

The trial compared Axpaxli with Regeneron’s Eylea (aflibercept) in patients with newly diagnosed wet age-related macular degeneration (AMD). Axpaxli met the primary endpoint of superiority at week 36.

Trial Results

Among 344 participants, the percentage of patients maintaining visual acuity (defined as losing fewer than 15 letters on a standard eye chart) was:

• Axpaxli: 74.1%

• Eylea: 55.8%

This represented:

• Observed difference: 18.3%

• Risk difference: 17.5%

Durability results were also favorable:

• Week 52 vision preservation:

  • Axpaxli: 65.9%

  • Eylea: 44.2%

The findings position Axpaxli as the first therapy with a novel mechanism to demonstrate superiority over an anti-VEGF therapy in an FDA-aligned wet AMD trial.

Investor Reaction Remains Mixed

Despite the positive data, Ocular Therapeutix shares fell roughly 25% after the announcement. Analysts suggested that expectations for the magnitude of benefit may have been higher. Some observers noted that Eylea performed better than anticipated in the control arm, compressing the apparent treatment effect.

Competing in a Multi-Billion-Dollar Market

Axpaxli would face formidable competition.

Regeneron reported $2.75 billion in Eylea sales in 2025, while also launching a high-dose formulation capable of dosing intervals of 8 to 16 weeks.

Roche’s Vabysmo has also gained traction as a longer-acting alternative.

Still, Axpaxli could carve out a niche as the first tyrosine kinase inhibitor therapy for wet AMD, introducing a mechanistically distinct approach to the disease.

Full SOL-1 results will be presented at an upcoming medical conference, and the trial will support a new drug application submission to the FDA.

For more details click here, here, and here.