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EYPT on Nasdaq

EyePoint Pharmaceuticals

American pharmaceuticals company

EyePoint Pharmaceuticals Inc. (formerly pSivida Corporation) is a Watertown, Massachusetts company specialising in the application of microelectromechanical systems (MEMS) and nanotechnology to drug delivery. pSivida obtained porous silicon technology from the British government Defence Evaluation and Research Agency (DERA, now QinetiQ). QinetiQ continues to be a strategic partner.3 Its shares trade on Nasdaq under the symbol EYPT.1 Wikipedia text CC BY-SA 4.0

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Last updated Oct 21, 2026.

Overview

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  • TickerEYPT on Nasdaq1
  • Industrypharmaceutical industry1
  • HeadquartersWatertown1
  • Websitewww.psivida.com
  • Legal formDelaware corporation1
  • Incorporated inDE5
  • Business address480 Pleasant Street, Suite C400, Watertown, Ma 024725
  • Filer categoryNon-accelerated filer, Smaller reporting company5
  • LEI549300QE1RU34T50MR694
  • StatusActive4
  • LEI statusIssued and current4
  • Registered addressc/o Corporation Service Company, 251 Little Falls Drive, 19808 Wilmington, United States4
  • Registered withDivision of Corporations, Department of State, 45150234

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EyePoint Pharmaceuticals Inc. (formerly pSivida Corporation) is a Watertown, Massachusetts company specialising in the application of microelectromechanical systems (MEMS) and nanotechnology to drug delivery.3

Financials

From the company’s reports to the SEC. Every number links to the filing it came from.

Key numbers, fiscal 2025

-776.0%Operating margin7
-739.4%Net margin7
-27.5%Revenue growth, 20257
-75.8%Return on equity7
-$243.4MFree cash flow7

What sells

Revenue by product, business segment and region, as the company reports it to the SEC.

Products and services

License and Collaboration Agreement brought in 53% of the revenue EyePoint Pharmaceuticals broke down this way in fiscal 2025.

  1. License and Collaboration Agreement$16.7M753%down 57% from 2024
  2. Royalty$13.0M742%up 708% from 2024
  3. YUTIQ Product$1.6M75%down 48% from 2024
Products and services by year
Products and services20242025
License and Collaboration Agreement$38.5M$16.7M
Royalty$1.6M$13.0M
YUTIQ Product$3.1M$1.6M

Regions

United States brought in 96% of the revenue EyePoint Pharmaceuticals broke down this way in fiscal 2025.

  1. United States$30.0M796%down 29% from 2024
  2. [Canada]$1.3M74%up 15% from 2024
  3. United Kingdoms$100.0K70%up 0% from 2024
Regions by year
Regions20242025
United States$42.0M$30.0M
[Canada]$1.1M$1.3M
United Kingdoms$100.0K$100.0K

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Research and development100¢$221.0M
  • Income tax0¢$279.0K

Out of $31.4M in revenue.7 The company lost money this year.

Financial statements

Revenue891011127$31.4M in 2025+54% since 2019
0$20.0M$40.0M$60.0M2019: $20.4M$20.4M20192020: $34.4M$34.4M2020+69%2021: $36.9M$36.9M2021+7%2022: $41.4M$41.4M2022+12%2023: $46.0M$46.0M2023+11%2024: $43.3M$43.3M2024−6%2025: $31.4M$31.4M2025−28%
Operating income891011127-$243.4M in 2025+409% since 2019
-$300.0M-$200.0M-$100.0M02019: -$47.9M-$47.9M20192020: -$37.3M-$37.3M2020−22%2021: -$55.3M-$55.3M2021+48%2022: -$99.6M-$99.6M2022+80%2023: -$75.1M-$75.1M2023−25%2024: -$145.9M-$145.9M2024+94%2025: -$243.4M-$243.4M2025+67%
Net income891011127-$232.0M in 2025+308% since 2019
-$300.0M-$200.0M-$100.0M02019: -$56.8M-$56.8M20192020: -$45.4M-$45.4M2020−20%2021: -$58.4M-$58.4M2021+29%2022: -$102.3M-$102.3M2022+75%2023: -$70.8M-$70.8M2023−31%2024: -$130.9M-$130.9M2024+85%2025: -$232.0M-$232.0M2025+77%

Every line of the income statement as filed: the last 2 fiscal years, latest first.7

Period ending2025-12-312024-12-31
Total revenues$31.4M$43.3M
Cost of sales$2.1M$3.7M
Research and development$221.0M$132.9M
Sales and marketing$90.0K$131.0K
General and administrative$51.6M$52.4M
Total operating expenses$274.8M$189.1M
Loss from operations-$243.4M-$145.9M
Interest and other income, net$11.8M$15.1M
Interest expense-$33.0K-$14.0K
Loss on extinguishment of debt$0$0
Total other income, net$11.8M$15.1M
Net loss before income taxes-$231.7M-$130.8M
Provision for income taxes-$279.0K-$90.0K
Net loss-$232.0M-$130.9M
Net loss per share - basic-$3.17-$2.32
Net loss per share - diluted-$3.17-$2.32
Weighted average common shares outstanding - basic73.3K shares56.3K shares
Weighted average common shares outstanding - diluted73.3K shares56.3K shares
Unrealized gain (loss) on available-for-sale securities-$67.0K$164.0K
Comprehensive income (loss)-$232.0M-$130.7M

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Corporate structure

EyePoint Pharmaceuticals sits at the top of its group. 6 entities, 2 countries on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of EyePoint Pharmaceuticals

  • EyePoint Pharmaceuticals Watertown, Massachusetts, United States
    • EyePoint Pharmaceuticals (United Kingdom) Subsidiary · United Kingdom
    • EyePoint Pharmaceuticals Securities Corporation Subsidiary · Massachusetts, United States
    • EyePoint US, Inc. Subsidiary · Delaware, United States
    • Icon Bioscience, Inc. Subsidiary · Delaware, United States
    • pSiMedica Limited Subsidiary · United Kingdom

Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); subsidiaries listed in Exhibit 21 of annual reports filed with the SEC; subsidiaries, stakes and holdings from Wikidata (CC0); major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What EyePoint Pharmaceuticals reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.

Property and equipment

ItemLatestA year beforeChange
Property and equipment, before depreciation$15.0M7 Dec 31, 2025$12.2M7 Dec 31, 2024+22.9%
Accumulated depreciation$6.0M7 Dec 31, 2025$4.1M7 Dec 31, 2024+48.3%
Property and equipment, net$9.0M7 Dec 31, 2025$8.2M7 Dec 31, 2024+10.3%
Operating-lease assets (leased space)$20.2M7 Dec 31, 2025$21.0M7 Dec 31, 2024−3.7%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$101.8M7 Dec 31, 2025$99.7M7 Dec 31, 2024+2.1%
Marketable securities, current$204.3M7 Dec 31, 2025$271.2M7 Dec 31, 2024−24.7%

Inventory

ItemLatestA year beforeChange
Inventory, total$1.8M7 Dec 31, 2025$2.3M7 Dec 31, 2024−21.3%
Raw materials$1.2M7 Dec 31, 2025$1.7M7 Dec 31, 2024−25.8%
Work in process$584.0K7 Dec 31, 2025$648.0K7 Dec 31, 2024−9.9%
Finished goods$012 Dec 31, 2024$1.7M12 Dec 31, 2023−100.0%

Properties, in its own words

We do not own any real property. We are headquartered in Watertown, Massachusetts, where we rent office, laboratory and manufacturing operations space. We entered into the original lease agreement on November 1, 2013, which included approximately 13,650 square feet of combined office and laboratory space for a term of five years, and was set to expire in April 2019. On May 17, 2018, we entered into an amendment to rent an additional 6,590 square feet of space and extend the term of the lease through May 31, 2025. We took occupancy of the additional space on September 10, 2018. On April 5, 2021, we further amended the lease by renting an additional 1,409 square feet of space and extending the term of the lease through May 31, 2025. We took occupancy of the additional space on July 1, 2021. On March 31, 2025, we further amended the lease to extend the term of the lease through May 31, 2028.

On March 8, 2022, we entered into an amendment (i) to extend the term of the lease to May 31, 2028 for 13,650 square feet of laboratory and manufacturing operations space; (ii) to rent an additional 11,999 square feet of office space through May 31, 2028, which commenced during the third quarter of 2022; and (iii) to terminate a portion of the lease comprising 7,999 square feet of office space in accordance with its existing contractual term on May 31, 2025. The amendment also reinstated our right to extend the lease for the space we occupy after May 31, 2025, for one additional period of five years. Rent for the extension period would be at the fair market rent for comparable space in comparable properties in the Watertown area.

The rest of Item 2

On January 23, 2023, we entered into a lease agreement with V.E. Properties IX, LLC for a new standalone manufacturing facility, including office and lab space located at 600 Commerce Drive, Northbridge, Massachusetts. The new leased premises consist of approximately 41,141 square feet. The lease includes a non-cancellable lease term of fifteen years and four months, with two options to extend the lease term for two additional terms of either five years or ten years at 95% of the then-prevailing fair market rent. The lease term, under ASC 842, commenced during the second quarter of 2024. The Company entered into an amendment to the Northbridge Lease, effective September 30, 2024. Pursuant to the amendment, the Company's obligation to pay base rent began March 1, 2025. The Company is responsible for real estate taxes, maintenance, and other operating expenses applicable to the leased premises.

We believe our leased facilities are adequate for our present and anticipated needs. Please refer to Note 8 to the Consolidated Financial Statements, included under Item 15, "Exhibits and Financial Statement Schedules," for further details.

Item 2 of the 10-K filed Mar 5, 2026.15

Leadership

Who has led EyePoint Pharmaceuticals, and when. Pick a name to see everywhere that person has worked.

Chief executive

  1. Paul Ashton2009–2016
  2. Nancy Lurker2016–2023
  3. Jay S. Duker2023–now

President

  1. Paul Ashton2009–2016
  2. Nancy Lurker2016–2022
  3. Jay S. Duker2023–now

Chief financial officer

  1. Michael Soja2007–2008
  2. George Elston2019–now

Chief operating officer

  1. Jay S. Duker2021–2023
2010201520202025
Board members and other officers (30)

Subsidiaries and ownership

Subsidiaries

  • EyePoint Pharmaceuticals (United Kingdom)

Subsidiaries (Exhibit 21)

  • EyePoint Pharmaceuticals Securities Corporation Massachusetts6
  • EyePoint US, Inc. Delaware6
  • Icon Bioscience, Inc. Delaware6
  • pSiMedica Limited United Kingdom6

From Wikidata.1 The subsidiaries the company lists in Exhibit 21 of its annual report, as filed.

Former names

  • EyePoint Pharmaceuticals, Inc.Apr 2, 2018 to Dec 8, 20255
  • pSivida Corp.Jun 19, 2008 to Mar 30, 20185
  • pSivida LTDJan 20, 2005 to Jun 18, 20085

Timeline

  1. Sep 10, 20268-K Other events52
  2. Aug 17, 20268-K Other events53
  3. Aug 5, 20268-K Results of operations54
  4. Jul 30, 20268-K Other events55
  5. Jul 17, 20268-K Entered a material agreement56
  6. Jun 22, 20268-K Executive or director change; Shareholder vote57
  7. May 14, 20268-K Other events58
  8. May 6, 20268-K Results of operations59
  9. Apr 13, 20268-K Other events60
  10. Mar 20, 20268-K Regulation FD disclosure61
  11. Mar 4, 20268-K Results of operations62
  12. Mar 2, 20268-K Other events63
  13. Jul 12, 2023New chief executive Jay S. Duker becomes CEO16
  14. Sep 20, 2016New chief executive Nancy Lurker becomes CEO17
  15. Nov 20, 2009New chief executive Paul Ashton becomes CEO18
  16. Mar 20, 2008Founded EyePoint Pharmaceuticals is founded4

Calendar

Coming up

  1. Nov 4, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.85) a share, on Nov 5, 2025.64

When it reported results

  1. Aug 5, 2026Reported quarterly or annual results54
  2. May 6, 2026Reported quarterly or annual results59
  3. Mar 4, 2026Reported quarterly or annual results62
  4. Jan 7, 2026Reported quarterly or annual results65
  5. Nov 5, 2025Reported quarterly or annual results66
  6. Oct 14, 2025Reported quarterly or annual results67
  7. Aug 6, 2025Reported quarterly or annual results68
  8. May 7, 2025Reported quarterly or annual results69

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar

Filings

422 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 91 major events, 193 insider forms, 50 large holders, 68 other. The latest 20:

  1. Oct 7, 2026SCHEDULE 13G/A EDGAR
  2. Sep 10, 20268-K EDGAR
  3. Sep 8, 2026SCHEDULE 13G EDGAR
  4. Aug 24, 20264 PRIMARY DOCUMENT EDGAR
  5. Aug 18, 20264 PRIMARY DOCUMENT EDGAR
  6. Aug 17, 20268-K EDGAR
  7. Aug 14, 2026SCHEDULE 13G/A EDGAR
  8. Aug 12, 2026SCHEDULE 13G EDGAR
  9. Aug 5, 2026S-8 EDGAR
  10. Aug 5, 202610-Q EDGAR
  11. Aug 5, 20268-K EDGAR
  12. Jul 31, 2026SCHEDULE 13G EDGAR
  13. Jul 30, 20268-K EDGAR
  14. Jul 28, 2026SCHEDULE 13G/A EDGAR
  15. Jul 22, 2026144/A EDGAR
  16. Jul 22, 2026144/A EDGAR
  17. Jul 21, 2026144 EDGAR
  18. Jul 17, 20268-K EDGAR
  19. Jul 14, 20264 PRIMARY DOCUMENT EDGAR
  20. Jul 2, 20264 PRIMARY DOCUMENT EDGAR

The 422 filings since October 2021 can be filtered by form type and year here when JavaScript is on.

Every filing from the last five years, summarized. The full record is on SEC EDGAR.

Insider trades

68 open-market trades by officers, directors and large owners since October 2021: 17 buys and 51 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Aug 18, 2026Zaderej Karen L.DirectorBuy10,600$4.93$52.3KForm 4
Jun 30, 2026Ribeiro RamiroChief Medical OfficerSale4,875$15.01$73.2KForm 4
Apr 17, 2026Ribeiro RamiroChief Medical OfficerSale2,437$15.00$36.6KForm 4
Mar 16, 2026Duker Jay S.President and CEOBuy1,500$13.15$19.7KForm 4
Mar 4, 2026Ribeiro RamiroChief Medical OfficerSale2,438$17.87$43.6KForm 4
Feb 17, 2026Ribeiro RamiroChief Medical OfficerSale2,437$15.00$36.6KForm 4
Jan 5, 2026Ribeiro RamiroChief Medical OfficerSale42,544$17.10$727.5KForm 4
Dec 4, 2025Lurker NancyDirectorSale9,300$15.11$140.5KForm 4
Dec 4, 2025Cormorant Asset Management, LPSale60,000$15.70$942.0KForm 4
Nov 28, 2025Lurker NancyDirectorSale500$14.95$7.5KForm 4
Nov 26, 2025Lurker NancyDirectorSale200$14.95$3.0KForm 4
Nov 11, 2025Ribeiro RamiroChief Medical OfficerSale2,722$11.61$31.6KForm 4
May 19, 2025Zaderej Karen L.DirectorBuy5,000$5.99$29.9KForm 4
May 16, 2025Zaderej Karen L.DirectorBuy5,000$5.81$29.1KForm 4
May 15, 2025Zaderej Karen L.DirectorBuy5,000$5.47$27.4KForm 4
May 14, 2025Zaderej Karen L.DirectorBuy5,000$5.42$27.1KForm 4
Aug 21, 2024ANDO GORANDirectorBuy5,000$7.95$39.8KForm 4
Aug 20, 2024DICICCO WENDY FDirectorBuy2,567$7.79$20.0KForm 4
Aug 19, 2024Zaderej Karen L.DirectorBuy12,500$7.98$99.8KForm 4
Aug 16, 2024Lurker NancyDirectorBuy3,173$7.88$25.0KForm 4

All 68 trades can be filtered by person here when JavaScript is on.

From Forms 4 filed with the SEC.

Major holders

Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.

Executive pay

What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.

YearExecutiveAgeSalaryTotal pay
2025Jay Duker67$696.3K$5.6M87
2025George Elston61$527.7K$2.2M87
2025Ramiro Ribeiro43$505.0K$2.2M87
2024President and Chief Executive Officer$669.5K$6.0M87
2024Chief Medical Officer$404.2K$3.5M87
2024Executive VicePresident and Chief Financial Officer$507.4K$3.2M87

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 100. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Montanova Capital, LLC8,296,375$118.6M2.5%No change
BlackRock, Inc.7,463,197$106.7M0.0%+285,860
Cormorant Asset Management, LP7,000,000$100.1M5.1%−1,265,000
Federated Hermes, Inc.5,681,052$81.2M0.1%+11,463
Adage Capital Partners Gp, L.l.c.4,827,792$69.0M0.1%+1,527,792
Franklin Resources Inc4,807,078$68.7M0.0%−241,520
Commodore Capital LP4,600,000$65.8M3.9%+1,775,000
Jupiter Topco LLC3,770,381$53.9M0.0%New
Vanguard Capital Management LLC3,630,252$51.9M0.0%+70,683
Paradigm Biocapital Advisors LP2,890,397$41.3M0.8%−252,040
State Street Corp2,357,545$33.7M0.0%+260,343
Geode Capital Management, LLC2,062,390$29.5M0.0%+78,725
Aberdeen Group plc2,008,802$28.7M0.0%+270,424
Citadel Advisors LLC1,977,610$28.3M0.0%+71,735
Balyasny Asset Management L.P.1,812,358$25.9M0.0%+373,621
Parkman Healthcare Partners LLC1,288,163$18.4M1.9%−66,637
Eventide Asset Management, LLC1,245,583$17.8M0.2%No change
Two Sigma Investments, LP1,181,143$16.9M0.0%+750,828
Essex Woodlands Management, Inc.1,084,857$15.5M6.1%No change
Orbimed Advisors LLC1,069,147$15.3M0.3%No change
5AM Venture Management, LLC1,050,000$15.0M5.2%No change
Rosalind Advisors, Inc.988,230$14.1M5.3%−48,507
Vanguard Portfolio Management LLC971,014$13.9M0.0%+177,144
Ameriprise Financial Inc848,410$12.1M0.0%+425,148
Dimensional Fund Advisors LP841,746$12.0M0.0%+440,625

13F reports cover disclosed long positions in U.S. stocks only.

SEC filer profile

How EyePoint Pharmaceuticals is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGAREyePoint, Inc.2
  • CIK0001314102
  • Employer ID (EIN)26-277444415
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company15
  • Incorporated inDelaware15
  • Fiscal year endsDecember 312
  • Industry code (SIC)3826 Laboratory Analytical Instruments2
  • SEC reviewing officeOffice of Industrial Applications and Services, Division of Corporation Finance2
  • Business address480 Pleasant Street, Suite C400, Watertown, MA 024722
  • Phone617-926-50002
  • Shares outstanding86,212,138 as of Jul 31, 202614
  • Public float$642.6M as of Jun 30, 202515
  • AuditorDeloitte & Touche LLP, Boston, Massachusetts PCAOB ID 34; no auditor attestation of internal control over financial reporting15
  • On EDGAR sinceJan 20, 20052
  • Filings1,342 in all: 4 (403), 8-K (273), 6-K (173), 10-Q (57), 3 (46), SC 13G/A (39), 424B5 (28), 144 (24)2
    All 51 form types

    DEF 14A (24), CORRESP (20), EFFECT (20), SC 13G (19), 10-K (18), DEFA14A (18), SCHEDULE 13G/A (17), UPLOAD (17), PRE 14A (16), S-8 (12), S-3 (11), F-3/A (10), 4/A (7), 424B3 (7), REGDEX (7), 8-K/A (6), F-3 (6), SC 13D/A (6), 144/A (5), SCHEDULE 13G (5), 10-K/A (4), 10-Q/A (4), CT ORDER (4), S-3/A (4), 20-F (3), D (3), POS AM (3), SC 13D (3), 5 (2), 6-K/A (2), ARS (2), FWP (2), SEC STAFF LETTER (2), 10-KT (1), 20FR12G (1), 3/A (1), 8-K12G3 (1), F-6 (1), F-6 POS (1), NT 10-K (1), NT 10-Q (1), NT 20-F (1), S-3ASR (1)

  • Latest filingsAnnual report (10-K) Mar 5, 2026
    Quarterly report (10-Q) Aug 5, 2026
    Proxy statement (DEF 14A) Apr 27, 2026
    Latest 8-K (8-K) Sep 10, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.001EYPTNasdaq

From the cover page of the 10-K filed Mar 5, 2026 (Section 12(b) of the Exchange Act).15

Risk factors and legal proceedings

The risks EyePoint Pharmaceuticals names in Item 1A of its 10-K filed Mar 5, 2026: 55 risks under these headings, as written.15

  • RISKS RELATED TO OUR FINANCIAL POSITION AND OUR CAPITAL RESOURCES
  • We will likely need additional capital to fund our operations. If we are unable to obtain sufficient capital, we will need to curtail and reduce our operations and costs and modify our business strategy.
  • We have incurred significant losses since our inception and anticipate that we will continue to incur losses for the foreseeable future.
  • We may never achieve profitability from future operations.
  • If we are unable to reach a final negotiated resolution with the U.S. government related to the DOJ investigation, the DOJ may commence an action against us, which could have a material adverse effect on our business, financial condition, results of operations, and cash flows. In addition, even if we finalize a negotiated resolution, we may be required to expend significant additional financial and managerial resources to comply with such agreements, including a corporate integrity agreement.
  • 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.
  • Our ability to use our net operating loss carryforwards and other tax attributes may be limited.
  • RISKS RELATED TO THE CLINICAL DEVELOPMENT AND REGULATORY APPROVAL OF OUR PRODUCT CANDIDATES
  • We are substantially dependent on success of our lead product candidate, DURAVYU, which is currently in the clinical development stage. If we are unable to complete development of, obtain regulatory approval for and commercialize DURAVYU in one or more indications and in a timely manner, our business, financial condition, results of operations and prospects will be significantly harmed.
  • The outcomes of clinical trials are uncertain, and delays in the completion of or the termination of any clinical trial of DURAVYU or our other product candidates could harm our business, financial condition, and prospects.
  • Disruptions at the FDA, including due to a reduction in the FDA’s workforce and/or inadequate funding for the FDA, could prevent the FDA from performing normal functions on which our business relies, which could negatively impact our business.
  • Clinical trial results may fail to support continued clinical investigations and/or approval of DURAVYU or our other product candidates.
The other 44 risks
  • Interim, top-line, initial and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to confirmation, audit and verification procedures that could result in material changes in the final data.
  • We may expend significant resources to pursue our lead product candidate, DURAVYU for the potential treatment of wet AMD and DME and fail to capitalize on the potential of DURAVYU, or our other product candidates, for the potential treatment of other indications that may be more profitable or for which there is a greater likelihood of success.
  • Phase 1 or 2 results from a clinical trial do not ensure that the trial will be successful and success in early stage clinical trials does not ensure success in later-stage clinical trials.
  • We may find it difficult to enroll patients in our clinical trials, which could delay or prevent clinical trials of our product candidates.
  • If we are unable to successfully expand our product lines through internal research and new therapeutic development or keep pace with rapid technological changes in the healthcare industry, our business may be materially and adversely affected.
  • RISKS RELATED TO THE COMMERCIALIZATION OF OUR PRODUCTS AND PRODUCT CANDIDATES
  • Our business strategy relies in part on our ability to successfully commercialize our product candidates, if approved; however, the products may not achieve market acceptance or be commercially successful.
  • Our product candidates, if approved and commercialized, may become subject to unfavorable pricing regulations, third-party reimbursement practices, or healthcare reform initiatives which could harm our business.
  • If we fail to comply with reporting and payment obligations under the Medicaid Drug Rebate program or other governmental pricing programs, we could be subject to additional reimbursement requirements, penalties, sanctions, and fines which could have a material adverse effect on our business, financial condition, results of operations, and growth prospects.
  • Even though regulatory approval DEXYCU® has been obtained in the U.S., we will still face extensive FDA regulatory requirements and may face future regulatory difficulties.
  • Our relationships with physicians, patients and payors in the U.S. are subject to applicable anti-kickback, fraud and abuse laws and regulations. In addition, we are subject to patient privacy regulation by both the federal government and the states in which we conduct our business. Our failure to comply with these laws could expose us to criminal, civil and administrative sanctions, reputational harm, and could harm our results of operations, and financial conditions.
  • If the market opportunities for our product candidates, including DURAVYU, are smaller than we believe they are, our results of operations may be adversely affected and our business may suffer.
  • If any of our product candidates have newly discovered or developed safety problems, our business would be seriously harmed.
  • The Affordable Care Act and any changes in healthcare laws may increase the difficulty and cost for us to commercialize our future products in the U.S. and affect the prices we may obtain.
  • The Inflation Reduction Act of 2022 and other changes in healthcare law may impact the prices we are able to obtain for our products and our obligations to make payments to the government.
  • Patient assistance programs for pharmaceutical products have come under increasing scrutiny by governments, legislative bodies and enforcement agencies. These activities may result in actions that have the effect of harming our business or reputation, or subjecting us to fines or penalties.
  • If competitive products are more effective, have fewer side effects, are more effectively marketed and/or cost less than our product candidates, or receive regulatory approval or reach the market earlier, our product candidates may not be approved and may not achieve the sales we anticipate and could be rendered noncompetitive or obsolete.
  • If the FDA or other applicable regulatory authorities approve generic products that compete with any of our product candidates, it could reduce the future sales of our product candidates.
  • Product liability lawsuits against us could cause us to incur substantial liabilities and to limit manufacturing or commercialization of new product candidates that we may develop and commercialize, including DURAVYU.
  • RISKS RELATED TO OUR INTELLECTUAL PROPERTY
  • If we are unable to protect our intellectual property rights or if our intellectual property rights are inadequate to protect our product candidates, our competitors could develop and commercialize technology and products similar to ours, and our competitive position could be harmed.
  • We may become involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time consuming and unsuccessful.
  • We may not be able to protect our intellectual property rights throughout the world.
  • Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which could be uncertain and could harm our business.
  • Our competitors may be able to circumvent our patents by developing similar or alternative technologies or products in a non-infringing manner.
  • Changes in either U.S. or foreign patent law or interpretation of such laws could diminish the value of patents in general, thereby impairing our ability to protect our products or product candidates.
  • We may be subject to claims asserting that our employees, consultants, independent contractors and advisors have wrongfully used or disclosed confidential information and/or alleged trade secrets of their current or former employers or claims asserting ownership of what we regard as our own intellectual property.
  • Intellectual property rights do not prevent all potential threats to competitive advantages we may have.
  • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
  • If our trademarks are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.
  • RISKS RELATED TO OUR RELIANCE ON THIRD PARTIES
  • The development and commercialization of our lead product candidate, DURAVYU, is dependent on intellectual property we license from Equinox Science and active pharmaceutical ingredient (API) supply of vorolanib. If we breach our agreement with Equinox Science, or the agreement is terminated, we could lose license rights that are material to our business.
  • If our Contract Research Organizations (CROs), Contract Manufacturing Organizations (CMOs), Contract Development Manufacturing Organizations (CDMOs), vendors, and investigators do not successfully carry out their responsibilities or if we lose our relationships with them, our development efforts with respect to our product candidates could be delayed.
  • We use our own facility for the manufacturing of YUTIQ® and rely on third party suppliers for key components, and any disruptions to our or our suppliers’ operations could adversely affect YUTIQ®’s commercial viability and our ability to supply YUTIQ® to Ocumension.
  • Our manufacturing operations currently depend on our Watertown, MA and Northbridge, MA facilities. If either location is destroyed or out of operation, our business may be adversely impacted.
  • Our employees, collaborators, service providers, independent contractors, principal investigators, consultants, co-promotion partners, vendors and CROs may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
  • Changes in U.S. and international trade policies may adversely impact our business and operating results.
  • RISKS RELATED TO OWNERSHIP OF OUR COMMON STOCK
  • The trading price of the shares of our common stock has been highly volatile, and purchasers of our common stock could incur substantial losses.
  • A small concentration of approximately ten stockholders beneficially own 62% of our total outstanding common stock, which gives certain stockholders significant control over matters subject to stockholder approval, which would prevent new investors from influencing significant corporate decisions.
  • Substantial future sales or other issuances of our common stock could depress the market for our common stock.
  • We do not currently intend to pay dividends on our common stock, and any return to investors is expected to come, if at all, only from potential increases in the price of our common stock.
  • Provisions in our charter documents could prevent or delay stockholders’ attempts to takeover our company.
  • Provisions in our bylaws provide for indemnification of officers and directors, which could require us to direct funds away from our business and the development of our product candidates.
  • GENERAL RISK FACTORS
  • We will need to grow the size of our organization, and we may experience difficulties in managing this growth.
  • Our business and operations would suffer in the event of computer system failures, cyberattacks or a deficiency in our cybersecurity.
  • If we fail to comply with data protection laws and regulations, we could be subject to government enforcement actions, which could include civil or criminal penalties, as well as private litigation and/or adverse publicity, any of which could negatively affect our operating results and business.

Legal proceedings

Information pertaining to legal proceedings can be found in Note 15. Contingencies, to the Notes to Consolidated Financial Statements (Part IV, Item 15 of this Annual Report on Form 10-K).

The opening of Item 3, Legal Proceedings.15

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