Iveena Delivery Systems, Inc.

Topical Eyedrops Increasing Lysyl Oxidase Activity to Control Myopia - Project Summary Pediatric Myopia, Also Known as Nearsightedness, Is an Eye Condition in Which One Is Unable to Bring Distant Objects Into Proper Focus. It Is the Leading Cause of Vision Impairment in the World. the Estimated Economic Impact of Uncorrected Refractive Error Is Estimated to Be a Loss of $202 Billion of Global Gross Domestic Product. the Prevalence of Myopia and High Myopia Are Increasing Globally at an Alarming Rate, With Significant Increases in the Risks for Vision Impairment From Pathologic Conditions Associated With High Myopia, Including Retinal Damage, Cataract and Glaucoma. in 2000, the Prevalence of Myopia Did Not Exceed 50% in Any of the Regions But, by 2050, the Prevalence Will Be = 50% in 57% of the Countries, If Current Trends Continue. We Propose a Novel Topical Eyedrop, IVMED-85, for Treating Myopia. It Is a First in Class Medication That Upregulates Lysyl Oxidase to Pharmacologically Induce Scleral and Corneal Crosslinking and Stiffening. Our Central Hypothesis Is That the Topical Copper Eyedrop Treatment May Enable a Non-invasive, Simple to Use, and Relatively Cost-effective Treatment for Myopia by Pharmacologically Inducing Scleral and Corneal Collagen Crosslinking. We Provide the First Evidence That Our Proprietary IVMED-85 Eyedrops Induce Biochemical Crosslinking and Biomechanical Stiffening in Cornea and Sclera and Reduced Refraction and Vitreous Depth in Guinea Pig Myopic Model (preliminary Results). in This Project, We Will Test Safety of IVMED-85 in Rabbits (aim 1) and Further Elucidate Efficacy and Duration of Effect After Cessation in Tree Shrews, a Para-primate Model. Our Plan Is to Achieve the Feasibility Results of Safety and Efficacy From This Proposed Phase 1 Project to Plan for a Phase 2 Sbir Assessing Optimal Duration in Primates and GLP Toxicology.