Research Project
9056861
? DESCRIPTION (provided by applicant): Tissue scarring associated with poor wound healing can be a serious problem, particularly when the scarring is in the eye. The exposed cornea is first to become involved in ocular infection, chemical or blast injuries. Worldwide, corneal diseases primarily resulting from infection, trauma, and surgical complications are responsible for 6 to 9 million cases of blindness in human patients. Poor corneal wound healing can result in permanent loss of corneal transparency and vision loss. Currently, there are limited medical and surgical treatments available to address this problem. Kalyra Pharmaceuticals has developed a series of novel potent, anti-scarring (anti-fibrotic) compounds, utilizing our toolbox of proprietay bioisosteres. With lead candidates in hand, we aim to demonstrate that these molecules can reduce scarring of the cornea after injury, via the Phase I proof of concept studies outlined below: Phase I: Demonstrate Reduction of Scarring in a Model of Corneal Wound Healing Aim 1. Preliminary formulation development for topical delivery to the eye Aim 2. Determine the extent of drug uptake in the cornea after topical administration Aim 3. Demonstrate efficacy by reducing scarring in a model of corneal wound healing Goal: Proof of concept for significant reduction of scarring of the cornea, and characterization of drug uptake in the cornea after topical administration. After the successful completion of the studies described in this Phase I application, we will continue the non- clinical development of a new treatment for reduction of fibrosis and scarring in the eye in Phase II.
