STTR Phase II: Intravitreal oxygen nanobubble technology for treatment of retinal artery occlusions

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is to develop an oxygen nanobubble platform technology to treat ischemic diseases of the eye, specifically Central Retinal Artery Occlusion (CRAO). The projected market for CRAO is an estimated 6,400 cases/year or $64 million, annually. The immediate goal of this project is to secure an Investigational New Drug (IND) indication for CRAO and then expand the platform technology to treat other ischemic conditions such as branch retinal artery occlusion (16,000 – 50,000 cases/year), retinal vein occlusions (~100,000 cases/year), and diabetic retinopathy (746,000 cases/year). The company has now expanded the oxygen nanobubble concept to treat chronic wounds, a $25 billion market affecting 9-12 million Americans. The company mission is to reduce the societal expenditures on healthcare costs, increase quality adjusted life years for patients, and reduce the burden of treatment. This Small Business Innovation Research Phase II project will develop an innovative technology to mitigate the severity of hypoxic insult due to retinal artery occlusions. The beachhead market is Central Retinal Artery Occlusion (CRAO), an acute blinding orphan disease for which no effective treatment exists. CRAO is an ophthalmologic emergency wherein the main artery that carries blood to the inner retina is occluded, in a stroke-like fashion by a plaque, resulting in sudden loss of vision. In humans, the window of opportunity for intervention exists between 24-36 hours after the occlusion before spontaneous reperfusion, which occurs in ~72 hours in about 90% of the cases. The company will develop, test, and validate a safe and stable oxygen nanodelivery formulation that can be delivered through pars plana, a standard method for administration of therapeutics into the vitreous cavity. The oxygen nanobubble formulation will be evaluated for oxygen holding capacity and release, tissue oxygenation, hypoxic mitigation, and preservation of function in ischemic rat eye models. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.