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- **Wet AMD Milestone**: SOL-R trial reaches 555-subject randomization, with SOL-1 on track for Q1 2026 data, targeting a superiority label.
- **DR Breakthrough**: HELIOS program uses ordinal DRSS endpoint, aiming for a broad label covering NPDR and DME, with single injection lasting 12 months.
- **Financial Security**: $445M equity financing extends cash runway to 2028, supporting clinical and commercial efforts.
- **Strategic Triad**: Superiority, market expansion (untreated NPDR patients), and seamless integration into existing workflows drive differentiation.

**【Management Opening Remarks】**
- William Slattery provided an overview of the call, referencing the press release and Q3 2025 financial results, including updates on AXPAXLI's registrational programs in wet AMD and non-proliferative diabetic retinopathy (NPDR). He highlighted the availability of the full report on the company's Investor Relations website.

**【CEO Commentary】**
- **Wet AMD Progress**: SOL-1 Phase III superiority trial remains on track for Q1 2026 top-line data. SOL-R, a non-inferiority trial, reached target randomization of 555 subjects, with a unique 6-month screening/loading phase to exclude high-risk patients. SOL-X, a long-term extension study, will evaluate 6-month dosing intervals and long-term outcomes.
- **Diabetic Retinopathy (DR) Strategy**: The HELIOS program aims for a broad label encompassing NPDR and DME. HELIOS-2 (6-month dosing) and HELIOS-3 (12-month dosing) use an ordinal DRSS endpoint, capturing improvement, stability, and worsening. This design increases statistical power and aligns with FDA guidance.
- **Financial Strength**: $345M cash on hand (excluding $445M from October equity financing), providing runway into 2028. Resources will support clinical trials, manufacturing, and commercial preparation.
- **Triad Strategy**: Emphasized superiority (potential first anti-VEGF with a superiority label), market expansion (untreated NPDR patients), and adaptability (same workflow as current anti-VEGFs).

**【Q&A Highlights】**
- **Label Expectations**: CEO indicated confidence in a superiority label for wet AMD based on SOL-1 and flexibility in dosing intervals. SOL-R's head-to-head data against high-dose EYLEA may enhance competitive positioning.
- **DR Enrollment**: Sites for HELIOS trials overlap with wet AMD studies, leveraging experienced investigators. NPDR patients are motivated by the potential for a single injection lasting 12 months.
- **Endpoint Confidence**: Ordinal DRSS endpoint validated by HELIOS-1 results (all NPDR patients improved with a single dose). FDA-aligned design reduces regulatory risk.
- **SOL-X Insights**: Crossover patients from pulsatile therapy may not catch up due to fibrosis, underscoring the benefit of early AXPAXLI treatment.


Ocular Therapeutix, Inc. (OCUL) Q3 2025 Earnings Call Transcript

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