Kala Pharmaceuticals, Inc., a biopharmaceutical company, focuses on the discovery, development, and commercialization of therapies using its proprietary mucus penetrating particles technology for the treatment of eye diseases. The company's product candidates include KPI-012, which is in clinical development stage for the treatment of persistent corneal epithelial defects; EYSUVIS for the short-term treatment of the signs and symptoms of dry eye disease; and INVELTYS, a topical twice-a-day ocular steroid for the treatment of post-operative inflammation and pain following ocular surgery. Its preclinical development products comprise KPI-287 that inhibits the vascular endothelial and platelet derived growth factors for the treatment of retinal diseases, including wet age-related macular degeneration, diabetic macular edema, and retinal vein occlusion; and selective glucocorticoid receptor modulators program, a novel class of compounds to regulate gene expression through the transrepression pathway while avoiding the transactivation pathway. The company was formerly known as Hanes Newco, Inc. and changed its name to Kala Pharmaceuticals, Inc. in December 2009. Kala Pharmaceuticals, Inc. was incorporated in 2009 and is headquartered in Watertown, Massachusetts.
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A smaller, earlier-stage Vertex Pharmaceuticals, focused on developing treatments for rare eye and respiratory diseases.
Similar to Ultragenyx or Sarepta Therapeutics, but specializing in rare ocular and respiratory conditions.
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- EYSUVIS: An FDA-approved ophthalmic corticosteroid suspension indicated for the short-term treatment of the signs and symptoms of dry eye disease.
- INVELTYS: An FDA-approved ophthalmic corticosteroid suspension indicated for the treatment of post-operative inflammation and pain following ocular surgery.
- KPI-012: An investigational therapy utilizing a mesenchymal stem cell secretome currently in clinical trials for the treatment of persistent corneal epithelial defect and other severe ocular diseases.
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Kala Bio (symbol: KALA) is currently a pre-commercial, research and development biopharmaceutical company.
In July 2023, Kala Bio divested its commercial ophthalmology assets, including its previously marketed products EYSUVIS and INVELTYS, to Alcon (symbol: ALC).
As a result of this divestiture and its current focus on preclinical drug discovery and development, Kala Bio does not currently have major commercial customers purchasing its products or services. The company's activities are centered on advancing its proprietary mesenchymal stem cell (MSC) secretome platform for novel therapies through research and development phases, rather than commercial sales.
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- AbbVie Inc. (ABBV)
- Alcon Inc. (ALC)
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Todd Bazemore, President and Chief Executive Officer
Mr. Bazemore was appointed permanent President and Chief Executive Officer of Kala Bio in September 2025, having served as interim CEO since February 2025 and previously as President and Chief Operating Officer. He brings over 30 years of experience in the biopharmaceutical industry, particularly in rare diseases. Prior to joining Kala Bio, he was Executive Vice President and Chief Operating Officer of Santhera Pharmaceuticals (USA), Inc. from September 2016 to November 2017. From April 2014 to January 2016, he served as Executive Vice President and Chief Commercial Officer of Dyax Corp., which was acquired by Shire plc. Before Dyax, he held various leadership roles at Sunovion Pharmaceuticals, Inc. (formerly Sepracor Inc.), prior to its acquisition by Dainippon Sumitomo Pharma.
Mary Reumuth, Chief Financial Officer
Ms. Reumuth has served as Kala Bio's Chief Financial Officer since July 2017, also holding the titles of Treasurer, Corporate Secretary, and Principal Accounting Officer. She previously served as Senior Vice President, Finance from February 2017 to July 2017, Vice President, Finance from December 2014 to February 2017, and Senior Director, Finance from February 2014 to December 2014, as well as Corporate Controller from February 2014 to July 2017.
Darius Kharabi, Chief Business Officer
Mr. Kharabi has served as Kala Bio's Chief Business Officer since November 2021. He co-founded and was Chief Executive Officer of Combangio Inc., a clinical-stage ophthalmology mesenchymal stem cell secretome company that Kala Bio acquired in November 2021. He is also the co-founder and Chief Operating Officer of Lagunita Biosciences, LLC, an early-stage medical investment company. Mr. Kharabi helped create and held leadership positions in several Lagunita portfolio companies, including xCella Biosciences, which was acquired by Ligand, and Kedalion Therapeutics, which was acquired by Novartis AG.
Kim Brazzell, Head of Research & Development and Chief Medical Officer
Dr. Brazzell has served as Kala Bio's Chief Medical Officer since February 2013. He was also a Principal of Acuity Advisors, LLC, an ophthalmic consulting company, from January 2014 to July 2018. Prior to that, Dr. Brazzell served as Chief Medical Officer of Mimetogen Pharmaceuticals, Inc., a clinical-stage biotechnology company, from January 2012 until December 2015. He also held several executive positions at Inspire Pharmaceuticals, Inc., a specialty pharmaceutical company focused on ophthalmic products.
Mark Iwicki, Chairman of the Board
Mr. Iwicki serves as the Chairman of the Board of Directors of Kala Bio. He previously served as the President and Chief Executive Officer of Kala Bio before stepping down in February 2025. Mr. Iwicki's prior experience includes serving as President and Chief Executive Officer of Civitas Therapeutics and Sunovion Pharmaceuticals Inc. He also held management positions at Novartis Pharmaceuticals Corporation, Astra Merck Inc., and Merck & Co., and has served on the boards of multiple other companies.
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The highly competitive and continuously evolving landscape of dry eye disease therapies presents a clear emerging threat to Kala Bio. With numerous established pharmaceutical companies developing and launching novel treatments, some of which feature different mechanisms of action, improved efficacy, better safety profiles (especially non-steroidal options), or more convenient dosing, Kala Bio's investigational dry eye therapy, INPRESA, faces the risk of being overshadowed. These competing therapies, many of which are already approved or in late-stage development from well-resourced players, could capture significant market share and limit the commercial viability and adoption of INPRESA, even if it gains regulatory approval. This dynamic is similar to how new, more advanced or convenient offerings can disrupt and erode the market for existing or developing products.
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Kala Bio (symbol: KALA) is a clinical-stage biopharmaceutical company focused on developing therapies for rare and severe eye diseases. The company's pipeline utilizes its proprietary mesenchymal stem cell secretome (MSC-S) platform.
The addressable markets for Kala Bio's main product candidates are:
- KPI-012 for Persistent Corneal Epithelial Defect (PCED): The estimated incidence of PCED is approximately 100,000 patients in the U.S. This represents a potentially sizable market opportunity, estimated to be over $1 billion, as there are currently no U.S. Food and Drug Administration (FDA)-approved prescription products with a broad indication covering all underlying etiologies of PCED.
- KPI-012 for Limbal Stem Cell Deficiency (LSCD): The estimated incidence of LSCD is 100,000 patients in the U.S., representing a potentially substantial market opportunity.
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For Kala Bio (symbol: KALA), there are currently no identifiable expected drivers of future revenue growth over the next 2-3 years based on the latest available information.
Kala Bio, a clinical-stage biopharmaceutical company, has recently announced the discontinuation of its lead product candidate, KPI-012, which was in development for the treatment of persistent corneal epithelial defect (PCED). This decision followed the failure of its Phase 2b CHASE clinical trial to meet its primary and key secondary efficacy endpoints.
Furthermore, the company explicitly stated its plans to cease the development of its entire proprietary mesenchymal stem cell secretome (MSC-S) platform. This platform was the foundation for all its investigational therapies, including KPI-012 for other rare corneal diseases like Limbal Stem Cell Deficiency (LSCD) and the preclinical program KPI-014 for inherited retinal diseases.
As a result of these significant clinical setbacks and the termination of its entire pipeline, Kala Bio currently has no approved or marketed products and consequently generates no revenue. The company's immediate focus has shifted to preserving cash, which includes workforce reductions and exploring various strategic options. Analyst forecasts for Kala Bio also reflect this, indicating zero revenue projections for both 2025 and 2026.
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Share Issuance
- KALA BIO completed a private placement in December 2024, raising approximately $10.75 million through the sale of common stock and Series I Convertible Non-Redeemable Preferred Stock.
- The number of shares outstanding for KALA BIO increased by 99.78% in the year prior to November 2025.
- A 1-for-20 reverse stock split was implemented by Kala Pharmaceuticals, Inc. (which later became KALA BIO) on December 26, 2023, to regain compliance with Nasdaq's minimum bid price requirement.
Inbound Investments
- KALA BIO secured approximately $10.75 million in a private placement from institutional investors including SR One, Cormorant Asset Management, and Woodline Partners in December 2024, to advance the clinical development of KPI-012.
- In December 2024, KALA BIO received $2.5 million under a California Institute for Regenerative Medicine (CIRM) award.
Outbound Investments
- Kala Pharmaceuticals acquired Combangio on November 15, 2021, expanding its pipeline with the clinical-stage biologic KPI-012. The acquisition involved an upfront cost of $5 million.
Capital Expenditures
- Capital expenditures for KALA BIO were -$175,000 in the 12 months leading up to November 7, 2025.
