Ocular Therapeutix shifts SOL-R endpoint timing, keeps AXPAXLI NDA on track for Q4 2026

Ocular Therapeutix reported third-quarter 2026 results on November 9, 2026, saying its planned New Drug Application for AXPAXLI in wet age-related macular degeneration remains on track for the fourth quarter of 2026 following completion of a positive Pre-NDA Meeting in September 2026.¹ The company said it intends to file under the 505(b)(2) pathway, which it believes could cut FDA review time by as much as 60 days versus the standard 505(b)(1) route for a new molecular entity.¹

The company is changing the design of its ongoing SOL-R trial. Ocular moved the SOL-R primary efficacy endpoint from Week 56 to Week 40, while key secondary endpoints stay at Weeks 56 and 96.¹ The company said the change was needed so that all subjects would pass the new primary endpoint visit before an interim Week 52 safety analysis, to protect the endpoint's statistical validity.¹ That change traces to a Type C meeting with FDA in May 2026, followed by protocol amendment, IRB approval and FDA alignment ahead of the interim analysis.¹ Topline SOL-R results are now expected in the first quarter of 2028, after secondary endpoints are evaluated, per the release.

Ocular also cited post-hoc SOL-1 analyses presented at the American Academy of Ophthalmology meeting and the Empire Forum: 71% of AXPAXLI-treated subjects were quantitatively dry at Week 8, and about 70% of those remained dry through Week 36.¹ Separately, 28% of AXPAXLI subjects had early persistent fluid, a group that showed worse visual outcomes and reached supplemental injection 32 weeks earlier than those without such fluid.¹ The company said preliminary SOL-R screening data show about 20% of otherwise eligible subjects were excluded for early persistent fluid or fluid fluctuations.¹

On HELIOS-3, the Phase 3 diabetic retinopathy trial, AXPAXLI dosed every 12 months is being tested against sham in about 620 patients.¹ The company also named Riad Sherif, MD, to its board,¹ noting he currently serves as CEO and Director of Oculis Holding AG.¹

Financially, cash and equivalents stood at $530.6 million as of September 30, 2026,¹ which the company said it believes is sufficient to fund operations into 2028.¹ Net revenue was $12.9 million for the quarter, versus $14.5 million a year earlier, while net loss widened to $94.8 million from $69.4 million.¹