Dry Eye

Dry Eye Disease is characterized as “A multifactorial disease of the ocular surface characterized by a loss of homeostasis of the tear film, and accompanied by ocular symptoms, in which tear film instability and hyperosmolarity, ocular surface inflammation and damage, and neurosensory abnormalities play etiological roles.” (DEWS II).

DED is a common problem in USA and based on data from the National Health and Wellness Survey, 6.8 percent of the United States adult population (approximately 16.4 million people) have been diagnosed with DED with higher prevalence of almost 20% among older individuals. Worldwide data indicates almost 2 billion people afflicted with DED. Over $6 Billion is spent on DED with no curative treatment available as of to date. DED market is growing at a CAGR of 5% and projected to exceed $9 Billion by 2030. Current treatments mostly require long treatment timelines (3-6 months) before any benefit is noticed although side effects show up much earlier. Assets that can deliver beneficial effects early with minimal adverse events would be highly desired.

IVW-1001 is part of the cryosims series of compounds created by Prof. Edward T. Wei who earlier identified and named the cooling molecule known as icilin. Cryosims are water-soluble and easy to deliver. They have a sufficient duration of action and evoke the full spectrum of cooling from cool, cold, frigid cold, to noxious cold. A cryosim produces sensations of coolness by acting on a transduction receptor called TRPM8, a member of the TRP family of cation channel proteins. When temperature drops, TRPM8 pores open, and axonal depolarization sends signals to the brain from the receptive field. TRPM8 is selective only for cold response as against other members of the receptor family. Unlike menthol, IVW-1001 is selective agonist for TRPM8.

IVW-1001 has already shown short duration of action and improvement in key sign and symptom relief in an Investigator Sponsored Clinical Trial. It was able to increase tear production within 05-20 minutes of administration and longer lasting effects after 2 weeks of administration. This benefit was not accompanied with any adverse events. IVW-1001 has currently completed phase 1/2 clinical studies in the U.S. and is targeted to release topline data in Q1 2025.