Stuart Therapeutics Announces Study May Proceed Letter from FDA – Phase 2

Welcome To Stuart Therapeutics

Stuart Therapeutics, established in 2017 is developing PolyCol, a unique therapeutic platform that has shown promise as a direct tissue reparative for collagen membranes and structures in the eye. PolyCol’s unique method of action results in accelerated healing and recovery in various ophthalmic disease states and offers a new way to address indications such as dry eye disease, dry age related macular degeneration and glaucoma.

PolyCol is based on patented research from a major U.S. university, combined with additional intellectual property acquired by Stuart Therapeutics.

Stuart’s first drug candidate based on the PolyCol platform, ST-100, is an extremely fast acting therapeutic that directly addresses the corneal tissue damage associated with dry eye disease. For a look at our non-confidential summary presentation, please click here.


Stuart Therapeutics’ first drug candidate is ST-100, a novel therapeutic in drop formulation for Dry Eye Disease (DED). Unlike most therapeutic solutions for DED, ST-100 is a fast acting, broadly applicable option for patients that has shown an ability to provide complete corneal healing in less than 24 hours in animal studies. ST-100 is believed to act by directly healing and aligning exposed and damaged collagen fibers in moderate to severe DED sufferers, providing an ideal environment for epithelial recovery and relief from painful symptoms.

Latest News

16 Apr. 2021
Stuart Therapeutics Announces Receipt of Study May Proceed Letter from U.S. FDA for ST-100 Dry Eye Disease Phase 2 Clinical Trial

Stuart Therapeutics (Stuart) announced today that the U.S. Food and Drug Administration (FDA) has completed its review of an Investigational New Drug (IND) application for Stuart’s investigational product ST-100, a topical drop formulation designed to treat ocular surface diseases, including dry eye disease, an indication that affects nearly 10% of the United States population.  As a result of this review, the FDA has issued a No-Holds, Study May Proceed letter to Stuart, permitting the company to begin its Phase 2 clinical trial on ST-100.

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19 Mar. 2021
Stuart Therapeutics Completes its $11M Series A Round, led by InFocus Capital Partners, WARF and MiMo Capital

Stuart Therapeutics, Inc. (“Stuart”), a clinical stage biopharmaceutical company conducting research and development of unique peptide therapeutics for ophthalmic diseases, today announced the completion of an $11 million Series A round of capital investment. The round was led by InFocus Capital Partners, an ophthalmology-focused life sciences venture capital fund, with significant participation by the Wisconsin

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13 Nov. 2020
Stuart Therapeutics Wins the AdvanSE Life Sciences Conference PitchRounds Competition

November 13th, 2020, Stuart, Florida For Immediate Release Stuart Therapeutics, Inc. (Stuart), a pre-clinical stage company developing advanced ophthalmic therapeutics, announced today that the company’s presentation at the Southeast Life Sciences AdvanSE Life Sciences Conference was judged the winner of the PitchRounds Competition.  The competition drew applications from over 70 applications.  Twenty companies were selected

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