Therapeutic Eye Drop for the Treatment of Corneal Injury After Chemical Burn
Abstract
Ocular trauma is one of the most common injuries reported by our Armed Forces, accounting for 16% of all injuries in Middle Eastern wars. Traumatic eye injuries render these injured Service Members significantly less likely to return to military duty and carry higher rates of life-long disability relative to other traumatic injuries. Chemical burn injury of the cornea represents a true ophthalmic emergency that can result in disfigurement, visual impairment, and blindness. The cornea is a thin layer that protects the front of the eye and is almost universally damaged by blast, burn, and chemical traumatic eye injuries. An intact cornea is essential for normal vision, while also acting as a vital barrier that prevents contaminants and bacteria from causing further harm to the eye. Significant damage to the cornea can result in a persistent epithelial defect (PED), which is defined as a failure of complete wound closure within 14 days despite supportive care. Corneal injuries are extremely painful and increase susceptibility to eye infection, and improper corneal healing or scarring can lead to life-long impairment or loss of vision. As such, it is paramount to accelerate corneal healing while limiting the excessive inflammation that exacerbates tissue damage and can cause corneal scarring. Unfortunately, the current standard-of-care treatments for corneal injuries, such as antibiotics and corticosteroids, do not accelerate or improve corneal wound healing and surgical procedures are often required to restore eyesight. There is an urgent military need for new traumatic eye treatments that can improve corneal healing while also preventing damaging inflammation and that can be easily administered in the field and during definite medical care. FirstString Research is focused on the development and advancement of new therapeutic products for inflammation and injury-based conditions. FirstString has developed a short peptide, aCT1, that modulates cellular junctions to decrease damaging inflammatory responses, prevent the spread of injury, and reboot the healing process to encourage healthy tissue regeneration. FirstString has led investigations of the topical aCT1 formulation (Granexin gel) through Investigational New Drug (IND) approval into evaluation in six clinical trials for multiple skin wounds and scarring. Ongoing preclinical studies and clinical trials show the efficacy and safety of aCT1/Granexin gel in the treatment of skin wounds. We hypothesize aCT1 s mechanism of action would translate to enhanced corneal healing and regeneration following traumatic ocular injury. Through previous Department of Defense contracts, we completed a comprehensive set of preclinical studies in animal models of corneal injuries simulating military-relevant traumatic events (e.g., blunt, burn, thermal, and chemical trauma, corrective surgery) to test the safety and efficacy of a novel aCT1 eye drop formulation (iNexinTM). iNexin significantly accelerated healing while reducing harmful inflammation, with no signs of irritation or toxicity in animal models. iNexin is stable with no significant degradation when stored at appropriate temperatures in an innovative multidose delivery system, which enables easy administration in any setting. We propose to build on promising preclinical data and completed formulation milestones to execute the final steps required for Food and Drug Administration approval and clinical trial evaluation of the novel ophthalmic aCT1 formulation. Our proposal objectives are to: (1) Perform preparatory steps for clinical trial evaluation; (2) Conduct a multi-center Phase 2 clinical trial evaluating the efficacy and safety of iNexin in treatment of PEDs after chemical burn injury; and (3) Perform data analysis and reporting. The proposed efforts are scheduled with milestones over a 2-year time period. Achieving these objectives will enable us to initiate a pivotal Phase 2b/3 clinical trial, a vital s
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Dec 28, 2022
- Source ID
- W81XWH2211113
Entities
People
- Christina Grek
Organizations
- United States Army