Coruna Medical LLC — Department of Defense SBIR Phase II: A15-061

Description

Chemical injuries to the eye remain a battlefield and clinical challenge with the potential to severely reduce vision and quality of life. During recent conflicts, burn was one of the most frequent sources of injury to the eye and adnexa. It is worth noting that chemical/thermal burn is an integral part of explosion injuries, which account for more than 70% of eye injuries on the battlefield. Chemical injuries to the eye cause immediate tissue damage and can lead to chronic complications and blindness. In contrast to acids, basic chemicals interact with fatty acids, leading to greater and faster (within minutes) tissue penetration, subsequent to saponification and disruption of cell membranes. Unfortunately, alkaline burn occurs more often than acid burn. The impact of severe chemical burns on the eye is profound, including eyelid skin damage, corneal opacification, neovascularization, limbal stem cell deficiency, anterior chamber inflammation, cataract formation, and even damage to the posterior segment including the development of glaucoma and loss of retinal ganglion cells. Current treatments focus on rapid removal of chemicals via irrigation and reducing subsequent inflammation to prevent complications. Despite these, detrimental damages to the ocular surface still occur. Treatments for chemical injuries, particularly in austere and prolonged field care settings are extremely limited. Therefore, an effective and ready-to-use therapeutic at the time of injury and a modality to prevent permanent vision-threatening sequelae in the sub-acute phase have the potential to change the current standard of care and positively affect outcomes for the injured Warfighter. In preliminary studies, our team found that the oxygen level in the aqueous humor decreased to 30% of normal level within a few minutes following acute alkaline burn. Hypoxia directly leads to tissue damage, and more importantly triggers leukocyte infiltration and the secretion of inflammatory cytokines. However, systemic delivery of oxygen, via hyperbaric chamber, nasal canula, or facial mask, is infeasible outside well-equipped medical facilities. Our team’s patented supersaturated oxygen emulsion (SSOE) is a biocompatible perfluorodecalin emulsion manufactured in hyperbaric condition and is capable of addressing this gap in topical oxygen delivery. Our preliminary data demonstrate that a single topical application of SSOE as an ophthalmic emulsion at time of alkali burn is efficacious in reducing ocular inflammation, opacity and cataract formation in vivo. The proposed sequential Phase II SBIR will allow Coruna to continue this important work in a larger animal model, fully characterize the SSOE, and develop a clear commercialization and regulatory path.