5 Key Takeaways

• 1

  Stuart Therapeutics submitted an FDA investigational new drug application amendment to study ST-100 (vezocolmitide) for corneal wound healing.

• 2

  The planned proof-of-concept study would expand ST-100 development beyond dry eye disease to epithelial and stromal repair after corneal injury.

• 3

  ST-100 is a collagen mimetic peptide developed with Stuart’s PolyCol technology and designed to target damaged helical collagen in the ocular extracellular matrix.

• 4

  Stuart plans a phase 2 trial in the second half of 2027 to assess ST-100 in wounds caused by surgery, trauma, ulcers, and chemical burns.

• 5

  Earlier phase 2 and initial phase 3 dry eye studies included more than 250 patients, but the initial phase 3 trial did not meet its primary Schirmer’s test endpoint.