Stuart Therapeutics submitted an investigational new drug (IND) application amendment to the FDA for ST-100 (vezocolmitide) ophthalmic solution, its lead candidate, for corneal wound healing.
First, let’s get some background on this asset.
ST-100’s active ingredient (vezocolmitide) is part of Stuart’s collagen mimetic peptide (CMP) platform (dubbed PolyCol).
That platform: is designed to tackle specific areas of collagen damage that can be affected in chronic eye diseases and potentially heal these ocular tissues. Click here to learn about PolyCol.
And check out our previous rundown on the investigational eye drop “designed to selectively repair damaged helical collagen.”
Hold up — isn’t ST-100 being evaluated for dry eye disease?
Itis. In fact, that investigational indication is much further in the clinical trial process (phase 3).
As evidenced by our last coverage (from June 2025): ST-100 demonstrated the potential for “fact-acting healing of ocular surface damage” caused by DED, with therapeutic effects described as “extremely rapid, providing relief within 2-4 days of treatment for both signs and symptoms.”
See here for that full data readout.
So, what do we know about this IND?
Not much, to be honest. Though it may be safe to assume that the original IND submission was for ST-100’s DED indication, which the FDA cleared in 2021.
How about this IND amendment?
In general: An amendment is a formal submission to the FDA to update, modify, or add essential information to an active IND application during clinical trials.
In this case: Stuart’s announcement of an amendment to the submission relates to a planned proof-of-concept (POC) study.
To note: This would mark ST-100’s “first expansion beyond DED and could extend its potential use to patients with corneal damage, regardless of cause.”
Tell me more.
Per Stuart, this POC study will evaluate how ST-100 supports epithelial and stromal healing in corneal wounds.
The plan: to follow-up the study with a phase 2 trial by H2 2027 (assuming this POC study kicks off in the coming months) that will look at the drop’s impact in “several types of corneal wounds”—including those caused by:
- Trauma
- Surgery
- Ulcers
- Chemical burns
And the potential?
For that phase 2 trial to offer “additional evidence of ST-100’s potential as a reparative therapy for the damaged ocular surface,” the company stated.
“We believe ST-100 is capable of repairing ocular helical collagen damaged by trauma, surgery and chemical burns, a need no currently approved therapeutic directly addresses,” stated President and CEO Eric Schlump.
Providing this new clinical program supports their belief, “ST-100 could become a topical therapy for a broad range of ocular surface conditions,” he added.
Duly noted. So what’s next?
That aforementioned POC study is expected to kick off shortly … though the exact timeframe is to be determined (publicly, at least).
As for ST-100’s DED indication: a phase 3 registrational trial is planned for early 2027.
As always, stay tuned for updates!
Gotcha. Now about this IND submission…
When reviewing an IND submission, the FDA generally looks to ensure the safety and rights of the research subjects as well as the quality of the scientific evaluation of the drug.
The review may include:
- Pharmacology and toxicology data from preclinical trials
- Proposed clinical trial protocols
- Info on manufacturing and quality control
How long does this review typically take?
Once received, the FDA has 30 days to review the application and determine if a clinical trial is safe to proceed.
- Generally: The application will go into effect 30 days after receipt (providing there is no clinical hold on it), or potentially earlier if the agency gives notice to a sponsor (the company or investigator of the trial).
Per federal rules, an IND-approved clinical trial’s start date must be at least 30 days after the FDA’s application acceptance.