Ocular Therapeutix, Inc 8-K Filing

FAQ

Key Financial Figures

• $0.0001 — ge on which registered Common Stock, $0.0001 par value per share OCUL The Nasdaq

Filing Documents

• tm2532882d1_8k.htm (8-K) — 28KB
• 0001104659-25-118940.txt ( ) — 189KB
• ocul-20251205.xsd (EX-101.SCH) — 3KB
• ocul-20251205_lab.xml (EX-101.LAB) — 33KB
• ocul-20251205_pre.xml (EX-101.PRE) — 22KB
• tm2532882d1_8k_htm.xml (XML) — 3KB

Forward-Looking Statements

Forward-Looking Statements This Current Report on Form 8-K contains forward-looking statements of Ocular Therapeutix, Inc. (the "Company") regarding future expectations, plans, and prospects for the Company; statements regarding the development and regulatory status of the Company's product candidate AXPAXLI (also known as OTX-TKI), including the Company's intentions, assuming the data are positive, to submit a new drug application for AXPAXLI based on year 1 data from the Company's SOL-1 Phase 3 clinical trial of AXPAXLI for the treatment of wet age-related macular degeneration; statements regarding the timing of the availability of data from the SOL-1 trial; and other statements containing the words "anticipate", "believe", "estimate", "expect", "intend", "designed", "goal", "may", "might", "plan", "predict", "project", "target", "potential", "will", "would", "could", "should", "continue", and similar expressions, all of which constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company's development programs, future results, performance, or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, uncertainties regarding the initiation, design, timing, conduct and outcomes of ongoing and planned clinical trials, including the Company's SOL-1 trial, SOL-R trial, planned SOL-X trial, HELIOS-2 trial, and HELIOS-3 trial; the risk that the U.S. Food and Drug Administration ("FDA") will not agree with the Company's interpretation of the written agreements under the Special Protocol Assessments for AXPAXLI, including for the SOL-1 trial; uncertainty as to whether the FDA will accept a

01 Other Events

Item 8.01 Other Events. The U.S. Food and Drug Administration ("FDA") has historically required two adequate and well-controlled clinical trials to demonstrate the safety and efficacy of ophthalmic product candidates, in particular for larger indications such as wet age-related macular degeneration ("wet AMD"). Following recent public statements from FDA leadership, as well as the Company's interactions with the FDA's Division of Ophthalmology subsequent to these statements, and assuming the data are positive, the Company now intends to submit a new drug application for its product candidate AXPAXLI (also known as OTX-TKI) for the treatment of wet AMD based on year 1 data from the Company's SOL-1 Phase 3 clinical trial, without waiting for additional clinical data from SOL-1, SOL-R or other clinical trials. The Company plans to engage with the FDA with respect to the regulatory pathway for AXPALI and will provide additional updates. The Company expects to report top-line data from year 1 of the SOL-1 clinical trial during the first quarter of 2026.

SIGNATURES

SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. OCULAR THERAPEUTIX, INC. Date: December 5, 2025 By: /s/ Donald Notman Donald Notman Chief Financial Officer and Chief Operating Officer

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View this 8-K filing on SEC EDGAR