Acute corneal epithelial injuries (corneal abrasions, foreign bodies, contact lens related injuries) are extremely common (more than 1 million per year). Injuries like corneal abrasions may lead to downstream consequences like corneal infections and inflammation, vision loss, and chronic wounds. Very limited interventions are currently available for these wounds. The standard of care for mild acute injuries is primarily supportive, with antibiotics given topically to prevent infectious complications. Severe cases may require ocular device placement, like amniotic membrane containing contact lenses, or even surgery. During the recovery time, patients suffer from pain, reduced vision and difficulty working and performing activities of daily living. The proposed work supports the development of a first-in-class, peptide-based, topical eye drop to accelerate the recovery time and allow patients to return to function sooner. This peptide therapy has a different mechanism of action than other eye drops given for ocular surface diseases. The objective of this Phase I STTR is to derisk the development of this novel therapy through two Aims (1) testing efficacy in invivo models of disease and (2) determination of ideal parameters for drug application. The proposed research is innovative as it is the first study to investigate the use of these peptides in critical derisking drug development models. These studies are significant because they will advance the development of a new therapeutic through the use of rigorous and well-defined methods in clinically relevant translational models of disease and serve as the basis for later stages of development to bring this therapy to patients. Success will be determined by efficacy testing above a clinically relevant threshold for improvement and establishment of critical dosing parameters. Phase II follow on studies would include 28-day toxicological testing, formulation development, chemistry-manufacturing-control (CMC) studies and scale up of peptide production for subsequent clinical trials. The results of these experiments will support an Investigational New Drug (IND) application to the Food and Drug Administration (FDA).
Public Health Relevance Statement: Public Health Relevance: In this STTR Phase I, ViSo Therapeutics Inc. is partnering with the University of Illinois at Chicago to develop and test the effectiveness of an eye drop based treatment for acute corneal wounds. These wounds can be seen after trauma, surgery, or other conditions. Acute corneal epithelial injuries are extremely common, affecting more than 1 million patients per year in the US alone. This treatment would provide a previously unavailable option for patients, reducing recovery time, during which they suffer from pain and impaired vision.
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