Ocular Therapeutix Lines Up Axpaxli for FDA Filing as Q3 Spending Climbs

Ocular Therapeutix (NASDAQ: OCUL) said it remains on track to file its FDA approval application for Axpaxli in wet age-related macular degeneration (wet AMD) this quarter. The update came with third-quarter results showing heavier spending as the company moves toward a potential launch. Shares traded near $6.53 on Monday, down about 1%.

Key Points

• Axpaxli’s application (NDA) for wet AMD is on track to be filed in Q4 2026 through the 505(b)(2) pathway.
• In the Phase 3 SOL-1 trial, 74.1% of Axpaxli patients kept their vision at Week 36, a 17.5-point advantage over aflibercept 2 mg.
• Net loss widened to $94.8M, or $0.42 per share, as R&D rose to $74.8M.
• Cash stood at $530.6M at the end of the quarter, enough to fund operations into 2028.
• Topline results from the second Phase 3 trial, SOL-R, are now expected in Q1 2028.

The Path to Filing

Ocular held a positive pre-NDA meeting with the FDA in September, which cleared the way for this quarter’s submission. The filing will include SOL-1 efficacy data through Week 52, along with interim one-year safety data from SOL-R.

SOL-1 has given Ocular its strongest case so far. Beyond the Week 36 primary endpoint, Axpaxli also hit a key secondary endpoint at Week 52: 65.9% of patients maintained vision, a 21.1-point advantage over aflibercept. That durability is the core pitch: a single implant that could replace frequent eye injections.

The competitive backdrop has also shifted. Ocular shares rose in August after EyePoint’s wet AMD trial missed, narrowing the field in what PMV has called the race to redefine wet AMD treatment.

The Fine Print Investors Are Weighing

Not every detail was clean. Post-hoc analyses found that about 28% of Axpaxli patients had persistent fluid early in treatment. Those patients had worse visual outcomes and needed more supplemental injections. In SOL-R screening, roughly 20% of otherwise eligible patients were excluded for fluid-related reasons.

Ocular also moved SOL-R’s primary endpoint from Week 56 to Week 40 and now expects topline results in Q1 2028. In addition, the SOL-X extension study will switch to dosing every 48 weeks.

Spending Up, Revenue Down

Total net revenue fell to $12.9M from $14.5M a year earlier. Meanwhile, R&D climbed to $74.8M from $52.4M, and the company is increasing spending to get ready for a commercial launch. As a result, net loss grew to $94.8M from $69.4M.

Even so, Ocular’s $530.6M cash position gives it runway into 2028. That should cover the NDA review, the SOL-R readout and the ongoing HELIOS-3 trial in diabetic retinopathy, which plans to enroll about 620 patients. The company also added Riad Sherif, MD, to its Board of Directors.

Ocular Therapeutix is a member of the PRISM Biotech Index.