Ocular Moves SOL-R Primary Endpoint to Week 40

The Tip Desk · November 12, 2026 · 3 min read

The company posted a $94.8 million net loss, or $0.42 a share, as it kept AXPAXLI’s wet AMD NDA on track for the fourth quarter of 2026.

Ocular Therapeutix (OCUL), an integrated biopharmaceutical company developing AXPAXLI for wet age-related macular degeneration, moved the SOL-R primary efficacy endpoint from Week 56 to Week 40 so every subject completes the primary visit before a planned Week 52 interim safety analysis, with key secondary endpoints still at Weeks 56 and 96 and topline results still on track for the first quarter of 2028.

The change, initiated after a May Type C meeting, was completed with FDA alignment ahead of that safety readout. SOL-R will remain masked through Week 96. Interim SOL-R Week 52 safety data are to be included in the planned AXPAXLI NDA submission. Combined with SOL-1, the interim analysis is expected to put more than 300 patients with at least one year of follow-up into the safety dataset.

Following a September 2026 Pre-NDA meeting, the company said the AXPAXLI NDA for wet AMD remains on track for the fourth quarter of 2026 under the 505(b)(2) pathway, which it said has the potential to shorten FDA review by up to 60 days versus a traditional new-molecular-entity filing. The planned submission is to be supported by SOL-1 Week 52 efficacy data, SOL-1 and interim SOL-R Week 52 safety data, and confirmatory evidence. SOL-R efficacy data are not required for that submission.

Post-hoc SOL-1 work presented at AAO and the Empire Forum framed the SOL-R design. At Week 8, 71% of AXPAXLI-treated subjects were quantitatively dry by an AI-based fluid analysis; about 70% of those remained dry through Week 36. A separate analysis found 28% of AXPAXLI-treated SOL-1 subjects had early persistent retinal fluid, with worse visual outcomes and a 32-week earlier time to first supplemental injection than subjects without early persistent fluid. Preliminary SOL-R screening indicated about 20% of otherwise eligible subjects were excluded from randomization for early persistent fluid or fluid variability.

SOL-X enrollment continued. The company said it plans to implement every 48-week dosing in the open-label protocol, reflecting durability shown in SOL-1. HELIOS-3, a Phase 3 trial in non-proliferative diabetic retinopathy designed for about 620 patients, remained in enrollment.

Total net revenue was $12.9 million for the third quarter of 2026, compared with $14.5 million a year earlier. Research and development expenses were $74.8 million, versus $52.4 million in the comparable 2025 quarter. The company attributed the increase to faster HELIOS-3 and SOL-X enrollment and more headcount and infrastructure. Selling and marketing expenses were $15.7 million, versus $13.1 million, which it said reflected personnel and pre-commercial investments for a potential AXPAXLI launch. General and administrative expenses were $18.8 million, versus $16.0 million.

Net loss was $94.8 million, or $0.42 a share, compared with a net loss of $69.4 million, or $0.38 a share, a year earlier. Cash and cash equivalents were $530.6 million as of September 30, 2026, down from $598.6 million as of June 30. The company said that balance, with expected DEXTENZA inflows, is sufficient to support planned operating expenses, debt service and capital expenditures into 2028, including SOL-1 completion, SOL-R, SOL-X and HELIOS-3, and pre-commercial work. It said the projection does not include the full costs of scaling manufacturing and the commercial team if AXPAXLI is approved. Outstanding shares were about 220.0 million as of November 6, 2026.

Ocular appointed Riad Sherif, MD, to its board. Dr. Sherif, currently chief executive of Oculis Holding AG, is scheduled to overlap with Seung Suh Hong, PhD, until year-end, when Dr. Hong is to step down.