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Ocular Therapeutix (OCUL) guidance and outlook

Ocular Therapeutix's 10-Q filed Nov 9, 2026 makes 32 forward-looking statements.

Guidance and outlook

Forward-looking statements, 10-Q filed Nov 9, 2026

• AXPAXLI, also known as OTX-TKI, is our investigational, bioresorbable, intravitreal hydrogel incorporating axitinib, a small molecule, multi-target, tyrosine kinase inhibitor with anti-angiogenic properties.
• We anticipate submitting a new drug application, or NDA, to the FDA for marketing approval of AXPAXLI for the treatment of wet AMD during the fourth quarter of 2026.
• We held a Type C meeting in May 2026 and a pre-NDA meeting in September 2026 with the FDA to review our plans to submit our NDA and our expectations for the NDA submission package.
• To provide safety information for a minimum of 300 subjects in the aggregate with at least one year of treatment with AXPAXLI in accordance with FDA guidance and to supplement the 170 subjects who received AXPAXLI in the SOL-1 trial, we plan to conduct an interim safety analysis of the SOL-R trial during the fourth quarter of 2026 assessing all subjects who have completed the Week 52 time point at the time of…
• Because axitinib is FDA-approved for non-ophthalmic indications, we plan to leverage the 505(b)(2) NDA review pathway which has the potential to shorten the review timeline for AXPAXLI by up to two months as compared to the traditional review pathway for new molecular entities.
• We decided to move the primary endpoint to Week 40 to preserve the integrity of the ongoing masked trial by ensuring all subjects will have passed the new primary endpoint visit and that the primary efficacy database will be complete before the planned interim Week 52 safety analysis takes place.
• To further assess differentiation from aflibercept (2 mg), dosed every eight weeks in the SOL-R trial, we also intend to evaluate the prevention of fibrosis and atrophy through secondary endpoints at Week 96 with the goal of expanding a potential AXPAXLI label in the future.
• We expect that this new key secondary superiority endpoint and the secondary fibrosis and atrophy endpoints have the potential to establish AXPAXLI as a best-in-disease agent for wet AMD and to further support our efforts to obtain broad global regulatory approvals and adoption of AXPAXLI if approved.
• In November 2025, we announced that the SOL-R trial achieved its randomization target of 555 subjects.
• We continued to allow randomization of previously enrolled subjects that were still in the loading phase when we achieved target randomization to maintain our commitment to both subjects and investigators.
• As discussed above under “Plans for Registration”, we plan to conduct an interim safety analysis of the SOL-R trial in the fourth quarter of 2026 to provide Week 52 safety data on subjects dosed with AXPAXLI in the trial in support of our NDA for AXPAXLI for the treatment of wet AMD.
• Based on the durability of AXPAXLI observed in the SOL-1 trial we plan to amend the SOL-X trial protocol to change the dosing interval to every 48 weeks, which we believe may more closely reflect potential real-world dosing of AXPAXLI, if approved.

Ocular Therapeutix's latest quarter

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What does Ocular Therapeutix expect?

AXPAXLI, also known as OTX-TKI, is our investigational, bioresorbable, intravitreal hydrogel incorporating axitinib, a small molecule, multi-target, tyrosine kinase inhibitor with anti-angiogenic properties. We anticipate submitting a new drug application, or NDA, to the FDA for marketing approval of AXPAXLI for the treatment of wet AMD during the fourth quarter of 2026. We held a Type C meeting in May 2026 and a pre-NDA meeting in September 2026 with the FDA to review our plans to submit our NDA and our expectations for the NDA submission package.

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Updated Nov 9, 2026. Read automatically from SEC filings and public data; errors are possible. Not investment advice.