Safety and Efficacy of ST-100 (Vezocolmitide) Ophthalmic Solution 60 μg/ml Ophthalmic Solution in Subjects Diagnosed With Dry Eye Disease (DED)

Summary

A Phase 3 Multi-Center, Randomized, Double Masked, Vehicle Controlled Study to Assess the Safety and Efficacy of ST-100 (vezocolmitide) Ophthalmic Solution 60 μg/ml Ophthalmic Solution in Subjects Diagnosed with Dry Eye Disease (DED)

Timeline

Start

2023-12-29

Primary completion

2024-06-30

Completion

2024-07-30

Publications

• Results Baratta RO, Schlumpf E, Buono BJD, DeLorey S, Calkins DJ. Corneal collagen as a potential therapeutic target in dry eye disease. Surv Ophthalmol. 2022 Jan-Feb;67(1):60-67. doi: 10.1016/j.survophthal.2021.04.006. Epub 2021 Apr 18.
• Results Fiscella RG. Understanding dry eye disease: a managed care perspective. Am J Manag Care. 2011 Dec;17 Suppl 16:S432-9.
• Results Hapach LA, VanderBurgh JA, Miller JP, Reinhart-King CA. Manipulation of in vitro collagen matrix architecture for scaffolds of improved physiological relevance. Phys Biol. 2015 Dec 21;12(6):061002. doi: 10.1088/1478-3975/12/6/061002.
• Results Kivanany PB, Grose KC, Yonet-Tanyeri N, Manohar S, Sunkara Y, Lam KH, Schmidtke DW, Varner VD, Petroll WM. An In Vitro Model for Assessing Corneal Keratocyte Spreading and Migration on Aligned Fibrillar Collagen. J Funct Biomater. 2018 Sep 21;9(4):54. doi: 10.3390/jfb9040054.
• Results Messmer EM. The pathophysiology, diagnosis, and treatment of dry eye disease. Dtsch Arztebl Int. 2015 Jan 30;112(5):71-81; quiz 82. doi: 10.3238/arztebl.2015.0071.
• Results Ousler GW 3rd, Rimmer D, Smith LM, Abelson MB. Use of the Controlled Adverse Environment (CAE) in Clinical Research: A Review. Ophthalmol Ther. 2017 Dec;6(2):263-276. doi: 10.1007/s40123-017-0110-x. Epub 2017 Sep 27.
• Results Shetty R, Deshpande K, Deshmukh R, Jayadev C, Shroff R. Bowman Break and Subbasal Nerve Plexus Changes in a Patient With Dry Eye Presenting With Chronic Ocular Pain and Vitamin D Deficiency. Cornea. 2016 May;35(5):688-91. doi: 10.1097/ICO.0000000000000785.
• Results Wareham LK, Holden JM, Bossardet OL, Baratta RO, Del Buono BJ, Schlumpf E, Calkins DJ. Collagen mimetic peptide repair of the corneal nerve bed in a mouse model of dry eye disease. Front Neurosci. 2023 May 16;17:1148950. doi: 10.3389/fnins.2023.1148950. eCollection 2023.

Drugs

Indications