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EyePoint, Inc.

EYPT
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Business Summary

EyePoint, Inc. is a clinical-stage biopharmaceutical company committed to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases. The Company's pipeline leverages its proprietary bioerodible Durasert E technology for sustained intraocular drug delivery. The Company's lead product candidate, DURAVYU, is an investigational sustained delivery treatment for vascular endothelial growth factor mediated retinal diseases combining vorolanib, a selective and patent-protected tyrosine kinase inhibitor with the Company's bioerodible Durasert E drug delivery technology. DURAVYU is currently being evaluated in Phase 3 pivotal trials for wet age-related macular degeneration and in Phase 3 clinical trials for diabetic macular edema. Additional pipeline programs include EYP-2301, razuprotafib, a TIE-2 agonist, formulated in Durasert E to potentially improve outcomes in serious retinal diseases. EyePoint is headquartered in Watertown, Massachusetts with a commercial manufacturing facility in Northbridge, Massachusetts.

The market for products treating eye diseases is highly competitive and is characterized by extensive research efforts and rapid technological progress. Many of the Company's competitors and potential competitors are larger, better established, more experienced, and have substantially more resources than the Company or its partners have. Competitors may reach the market earlier, may have obtained or could obtain patent protection that dominates or adversely affects the Company's products and potential products, and may offer products with greater efficacy, lesser or fewer side effects, and/or other competitive advantages. The Company believes that competition for treatments of eye diseases is based upon the effectiveness of the treatment, side effects, time to market, reimbursement and price, reliability, ease of administration, dosing or injection frequency, patent position, and other factors. Many companies have or are pursuing products to treat eye diseases that are or would be competitive with DURAVYU and other pipeline products, including FDA-approved LUCENTIS, EYLEA, EYLEA HD, VABYSMO, and off-label use of AVASTIN, as well as investigational treatments from REGENXBIO Inc., Adverum Biotechnologies, Inc., 4D Molecular Therapeutics, Merck (EyeBio), Ollin Biosciences, Inc., Ocular Therapeutix, Inc., Kodiak Sciences, Inc., and Oculis Holding AG.

The Company generates revenue through product sales, license and collaboration agreements, and royalty income. Revenue is recognized when a customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. The Company's primary customer segments include commercialization partners such as ANI Pharmaceuticals, Inc. and Ocumension Therapeutics. The Company's business model also involves licensing its proprietary Durasert drug delivery technology to partners for the development and commercialization of products such as ILUVIEN and YUTIQ.

The Company's lead product candidate, DURAVYU, is an investigational sustained delivery treatment for VEGF mediated retinal diseases combining vorolanib, a selective and patent-protected TKI with the Company's bioerodible Durasert E drug delivery technology. DURAVYU is currently being evaluated in Phase 3 pivotal trials (LUGANO and LUCIA) for wet AMD and in Phase 3 clinical trials (COMO and CAPRI) for DME. The LUGANO trial enrolled 432 patients and the LUCIA trial enrolled 475 patients who were randomly assigned, 1:1, to a DURAVYU 2.7mg arm or an on-label aflibercept control arm. In DME, each trial will enroll approximately 240 patients . Additional pipeline programs include EYP-2301, razuprotafib, a TIE-2 agonist, formulated in Durasert E to potentially improve outcomes in serious retinal diseases. The Company also has FDA-approved products licensed to other entities, including YUTIQ for posterior segment uveitis and ILUVIEN for DME. In May 2023, the Company licensed rights to YUTIQ to ANI for $82.5 million with $75.0 million paid up-front and $7.5 million paid in equal quarterly installments in 2024. The Company is also entitled to low to mid double-digit royalty on ANI's related U.S. net sales above defined thresholds for the calendar years 2025-2028 .

During 2025, the Company achieved significant clinical and regulatory milestones for DURAVYU. The Company successfully completed enrollment in its two pivotal Phase 3 clinical trials: the LUGANO trial on May 27, 2025 , and the LUCIA trial on July 29, 2025 . On October 14, 2025, the Company entered into an underwriting agreement with J.P. Morgan Securities LLC, Jefferies LLC, Citigroup Global Markets Inc. and Guggenheim Securities, LLC, as representatives of the underwriters, in connection with an underwritten public offering of 11,000,000 shares of common stock and, to certain investors, in lieu of common stock, pre-funded warrants to purchase 1,500,000 shares of common stock. The price to the public for the Shares in the Offering was $12.00 per Share and the price to the public for the PFWs was $11.999 per PFW. The net proceeds from the Offering were approximately $162.1 million , after deducting underwriting discounts and commissions. On March 18, 2025, ANI announced that it completed the buyout of its 3.125% perpetual royalty obligation to SWK on worldwide net revenues of ILUVIEN and YUTIQ for a one-time payment of $17.25 million . As a result, the Company terminated the RPA effective March 18, 2025 . The Company also sold 825,844 shares of its common stock under the ATM facility at a weighted average price of $14.10 per share for gross proceeds of approximately $11.6 million .

For the year ended December 31, 2025, total revenues were $31.371 million , compared to $43.273 million for the year ended December 31, 2024. Net loss was $231.962 million for 2025, compared to $130.870 million for 2024. Net loss per share - basic and diluted was $3.17 for 2025, compared to $2.32 for 2024. Research and development expenses increased by $88.1 million , or 66% , to $221.039 million for 2025 from $132.926 million in the prior year. As of December 31, 2025, the Company had cash, cash equivalents, and investments in marketable securities of $306.1 million .

Business Outlook

The Company believes that its cash, cash equivalents and investments in marketable securities of $306.1 million at December 31, 2025 will enable it to fund operations into the fourth quarter of 2027 , beyond Phase 3 wet AMD topline data for DURAVYU expected in 2026 .

The Company's primary growth vector is the advancement of DURAVYU through Phase 3 clinical development and, if successful, regulatory filings for wet AMD and DME. Enrollment in the pivotal Phase 3 clinical trials for wet AMD is complete with data expected beginning in mid-2026 . The first patient was dosed in the Phase 3 DME program in February 2026 . The Company believes that DURAVYU has two potential blockbuster indications and that DURAVYU is on track to be the first-to-market of the current investigational sustained release treatments for wet AMD . The Company also plans to advance DURAVYU into additional retinal disease indications and advance EYP-2301 into clinical development for serious retinal diseases.

The Company expects to continue to incur significant expenses and operating losses for the foreseeable future . Research and development expenses increased by $88.1 million , or 66% , to $221.039 million for 2025 from $132.926 million in the prior year, primarily attributable to ongoing DURAVYU Phase 3 clinical trials and scale-up of the Northbridge commercial manufacturing facility.

The Company's manufacturing operations currently depend on its Watertown, MA and Northbridge, MA facilities. In October 2024, the Company announced the grand opening of its commercial manufacturing facility in Northbridge, MA. The 41,000 square foot Good Manufacturing Process compliant commercial manufacturing facility was built to meet U.S. FDA and EMA standards and will support global manufacturing across the Company's portfolio, including lead pipeline asset, DURAVYU upon potential regulatory approval. Manufacturing tech transfer of DURAVYU from Watertown to Northbridge began during 2025 . As of February 27, 2026, the Company had 214 employees , all of which were full-time, all located in the United States.

The Company expects to continue to incur significant expenses and operating losses for the foreseeable future . The Company anticipates that its expenses will continue to be significant if, and as, it continues the research and pre-clinical and clinical development of its product candidates, including DURAVYU and EYP-2301, initiates additional pre-clinical studies, clinical trials, or other studies or trials for DURAVYU, EYP-2301, and its other product candidates, adds additional operational, financial and management information systems, and personnel, including personnel to support its development and commercialization planning efforts, complies with the terms of a settlement agreement and corporate integrity agreement in connection with a final negotiated resolution with the U.S. government related to the DOJ investigation, hires additional commercial, clinical, manufacturing and scientific personnel, and engages third party commercial, clinical and manufacturing organizations, further develops the manufacturing process for its product candidates, changes or adds additional manufacturers or suppliers, seeks regulatory approvals for its product candidates that successfully complete clinical trials, seeks to identify and validate additional product candidates, acquires or in-licenses other products, product candidates, and technologies, maintains, protects, and expands its intellectual property portfolio, creates additional infrastructure to support its product development and planned future commercial sale efforts, and experiences any delays or encounters issues with any of the above.

The Company will need to raise additional capital in the future to help fund the development and commercialization of DURAVYU and its other product candidates, if approved . The amount of additional capital the Company will require will be influenced by many factors, including its clinical development plans for DURAVYU for the treatment of wet AMD and DME and its other product candidates, including EYP-2301, the outcome, timing and cost of the regulatory approval process for DURAVYU and its other product candidates, including the potential for the FDA to require that it perform more studies and clinical trials than those it currently expects, whether and to what extent it internally funds, whether and when it initiates, and how it conducts other product development programs, whether and when it is able to enter into strategic arrangements for its products or product candidates and the nature of those arrangements, the costs involved in preparing, filing, and prosecuting patent applications, and maintaining, and enforcing its intellectual property rights, changes in its operating plan, resulting in increases or decreases in its need for capital, its views on the availability, timing and desirability of raising capital, and the costs associated with any settlement documents with the U.S. government related to the DOJ investigation, including a corporate integrity agreement.

The Company faces structural headwinds including the highly competitive nature of the market for products treating eye diseases, which is characterized by extensive research efforts and rapid technological progress. Many of the Company's competitors and potential competitors are larger, better established, more experienced, and have substantially more resources than the Company or its partners have. The Company also faces risks related to the clinical development and regulatory approval of its product candidates, including the uncertainty of clinical trial outcomes, potential delays in the completion of or termination of any clinical trial, and the risk that clinical trial results may fail to support continued clinical investigations and/or approval of DURAVYU or its other product candidates. Additionally, the Company faces risks related to the commercialization of its products and product candidates, including the potential that the products may not achieve market acceptance or be commercially successful, and unfavorable pricing regulations, third-party reimbursement practices, or healthcare reform initiatives which could harm the business.

The Company faces execution risks including the substantial dependence on the success of its lead product candidate, DURAVYU, which is currently in the clinical development stage. If the Company is unable to complete development of, obtain regulatory approval for and commercialize DURAVYU in one or more indications and in a timely manner, its business, financial condition, results of operations and prospects will be significantly harmed. The Company also faces risks related to its reliance on third parties, including the development and commercialization of DURAVYU being dependent on intellectual property it licenses from Equinox Science and active pharmaceutical ingredient supply of vorolanib, which it currently sources from a sole supplier. The Company also faces risks related to the DOJ investigation into certain of its sales, marketing and promotional practices as pertain to DEXYCU, and if it is unable to reach a final negotiated resolution with the U.S. government, the DOJ may commence an action against it, which could have a material adverse effect on its business, financial condition, results of operations, and cash flows.

Risk Factors

The Company is substantially dependent on the clinical and future commercial success of its lead product candidate, DURAVYU, which is currently in Phase 3 global clinical trials for wet AMD and DME. If the Company is unable to complete development of, obtain regulatory approval for and commercialize DURAVYU in one or more indications and in a timely manner, its business, financial condition, results of operations and prospects will be significantly harmed. The Company has incurred significant losses since its inception and is not profitable, with a total accumulated deficit of $1,105.0 million at December 31, 2025, and net losses of $231.962 million and $130.870 million for the years ended December 31, 2025 and 2024, respectively. The Company will likely need additional capital to fund its operations, and as of December 31, 2025, its cash, cash equivalents, and investments in marketable securities totaled $306.1 million , which it believes will enable it to fund operations into the fourth quarter of 2027 . The Company is unable to reach a final negotiated resolution with the U.S. government related to the DOJ investigation into certain of its sales, marketing and promotional practices as pertain to DEXYCU, and if it is not able to conclude a final resolution, the DOJ may elect to proceed against it and seek damages in excess of the agreed in principle settlement amount of approximately $4.7 million plus interest. The development and commercialization of DURAVYU is dependent on intellectual property the Company licenses from Equinox Science and active pharmaceutical ingredient supply of vorolanib, which it currently sources from a sole supplier. If the Company breaches its agreement with Equinox Science, or the agreement is terminated, it could lose license rights that are material to its business.

Management Priorities

Management's message emphasizes the significant clinical and regulatory milestones achieved for DURAVYU during 2025, including the successful completion of enrollment in the pivotal Phase 3 LUGANO and LUCIA clinical trials for wet AMD and the positive results from the Phase 2 VERONA clinical trial for DME. Management believes that DURAVYU is on track to be the first-to-market of the current investigational sustained release treatments for wet AMD and that DURAVYU has two potential blockbuster indications . Management's strategic priorities for the period ahead include advancing DURAVYU through Phase 3 clinical development and, if successful, regulatory filings for wet AMD and DME, preparing for the potential commercial launch of DURAVYU in the United States in anticipation of successful trial outcomes and FDA approval, leveraging the new state-of-the-art Northbridge, MA manufacturing facility to support the potential commercial launch of DURAVYU, advancing DURAVYU into additional retinal disease indications, advancing EYP-2301 into clinical development for serious retinal diseases, and expanding the product pipeline through internal discovery, research collaborations, in-licensing arrangements, or acquisition. Management also states that the Company believes that its cash, cash equivalents, and investments in marketable securities of $306.1 million at December 31, 2025 will enable it to fund operations into the fourth quarter of 2027 , beyond Phase 3 wet AMD topline data for DURAVYU expected in 2026 .

View Source Annual Report on SEC.gov ↗

References

  1. [1] Item 1, Business — DURAVYU for wet AMD - Clinical Development
  2. [2] Item 1, Business — DURAVYU for wet AMD - Clinical Development
  3. [3] Item 1, Business — DURAVYU for Diabetic Macular Edema - Clinical Development
  4. [4] Item 1, Business — YUTIQ for posterior segment uveitis
  5. [5] Item 1, Business — YUTIQ for posterior segment uveitis
  6. [6] Item 1, Business — YUTIQ for posterior segment uveitis
  7. [7] Item 1, Business — YUTIQ for posterior segment uveitis
  8. [8] Item 1, Business — DURAVYU Clinical Development and Pipeline Progress
  9. [9] Item 1, Business — DURAVYU Clinical Development and Pipeline Progress
  10. [10] Item 7, MD&A — Fiscal 2025 Overview
  11. [11] Item 7, MD&A — Fiscal 2025 Overview
  12. [12] Item 7, MD&A — Fiscal 2025 Overview
  13. [13] Item 7, MD&A — Fiscal 2025 Overview
  14. [14] Item 7, MD&A — Fiscal 2025 Overview
  15. [15] Item 7, MD&A — Fiscal 2025 Overview
  16. [16] Item 7, MD&A — Fiscal 2025 Overview
  17. [17] Item 7, MD&A — Fiscal 2025 Overview
  18. [18] Item 7, MD&A — Liquidity and Capital Resources
  19. [19] Item 7, MD&A — Liquidity and Capital Resources
  20. [20] Item 7, MD&A — Liquidity and Capital Resources
  21. [21] Item 7, MD&A — Results of Operations
  22. [22] Item 7, MD&A — Results of Operations
  23. [23] Item 7, MD&A — Results of Operations
  24. [24] Item 7, MD&A — Results of Operations
  25. [25] Item 7, MD&A — Results of Operations
  26. [26] Item 7, MD&A — Results of Operations
  27. [27] Item 7, MD&A — Results of Operations
  28. [28] Item 7, MD&A — Results of Operations
  29. [29] Item 7, MD&A — Results of Operations
  30. [30] Item 7, MD&A — Results of Operations
  31. [31] Item 1A, Risk Factors — We will likely need additional capital to fund our operations
  32. [32] Item 1A, Risk Factors — We will likely need additional capital to fund our operations
  33. [33] Item 1A, Risk Factors — We will likely need additional capital to fund our operations
  34. [34] Item 1, Business — Overview
  35. [35] Item 1, Business — DURAVYU Clinical Development and Pipeline Progress
  36. [36] Item 1, Business — DURAVYU Clinical Development and Pipeline Progress
  37. [37] Preliminary Note Regarding Forward-Looking Statements
  38. [38] Preliminary Note Regarding Forward-Looking Statements
  39. [39] Item 1A, Risk Factors — We have incurred significant losses since our inception and anticipate that we will continue to incur losses for the foreseeable future
  40. [40] Item 7, MD&A — Results of Operations
  41. [41] Item 7, MD&A — Results of Operations
  42. [42] Item 7, MD&A — Results of Operations
  43. [43] Item 7, MD&A — Results of Operations
  44. [44] Item 1, Business — Manufacturing
  45. [45] Item 1, Business — Manufacturing
  46. [46] Item 1, Business — Human Capital Resources
  47. [47] Item 1A, Risk Factors — We have incurred significant losses since our inception and anticipate that we will continue to incur losses for the foreseeable future
  48. [48] Item 1A, Risk Factors — We will need to raise additional capital in the future, which may not be available on favorable terms and may be dilutive to stockholders or impose operational restrictions
  49. [49] Item 7, MD&A — Liquidity and Capital Resources
  50. [50] Item 7, MD&A — Results of Operations
  51. [51] Item 7, MD&A — Results of Operations
  52. [52] Item 1A, Risk Factors — We will likely need additional capital to fund our operations
  53. [53] Item 1A, Risk Factors — We will likely need additional capital to fund our operations
  54. [54] Item 1A, Risk Factors — If we are unable to reach a final negotiated resolution with the U.S. government related to the DOJ investigation
  55. [55] Preliminary Note Regarding Forward-Looking Statements
  56. [56] Preliminary Note Regarding Forward-Looking Statements
  57. [57] Preliminary Note Regarding Forward-Looking Statements
  58. [58] Preliminary Note Regarding Forward-Looking Statements
  59. [59] Preliminary Note Regarding Forward-Looking Statements
  60. [60] Item 7, MD&A — Results of Operations
  61. [61] Item 7, MD&A — Results of Operations
  62. [62] Item 7, MD&A — Results of Operations
  63. [63] Item 7, MD&A — Results of Operations
  64. [64] Item 7, MD&A — Results of Operations
  65. [65] Item 7, MD&A — Results of Operations
  66. [66] Item 7, MD&A — Results of Operations
  67. [67] Item 7, MD&A — Results of Operations
  68. [68] Item 1A, Risk Factors — We will likely need additional capital to fund our operations
  69. [69] Item 7, MD&A — Liquidity and Capital Resources
  70. [70] Item 7, MD&A — Results of Operations
  71. [71] Item 7, MD&A — Results of Operations
  72. [72] Item 7, MD&A — Results of Operations
  73. [73] Item 7, MD&A — Results of Operations
  74. [74] Item 7, MD&A — Results of Operations
  75. [75] Item 7, MD&A — Results of Operations
  76. [76] Item 7, MD&A — Results of Operations
  77. [77] Item 7, MD&A — Results of Operations
  78. [78] Item 7, MD&A — Results of Operations
  79. [79] Item 7, MD&A — Results of Operations
  80. [80] Item 7, MD&A — Results of Operations
  81. [81] Item 7, MD&A — Results of Operations
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  83. [83] Item 7, MD&A — Results of Operations

Analysis on 6/22/2026