Invirsa has submitted an investigational new drug application to the FDA for INV-102, a medication intended to treat ocular conditions and dry eye caused by DNA damage.
In preclinical studies, INV-102 showed safe healing activity for several conditions caused by DNA damage.
Patient trials are expected to begin at the end of August, with safety and efficacy results expected at the beginning of 2023.
"Following the acceptance of our IND application, we are looking forward to beginning INV-102’s first human clinical trial in dry eye to demonstrate clinical safety and initial clinical efficacy," Robert Shalwitz, MD, Invirsa's CEO, said in an Aug. 25 press release. "This will clear the way for future investigational use of INV-102 as a therapeutic for various ocular conditions through the unique mechanism of enhanced DNA repair."