This Small Business Innovation Research (SBIR) Phase I project will demonstrate the feasibility of healing wounds to the surface of the eye with a novel biomaterial. This biomaterial resembles a contact lens and initial animal studies show that when placed on a wounded eye it acts as a regenerative bandage that stimulates healing while simultaneously absorbing naturally over time.
The broader/commercial impacts of this research are significant to the Americans that suffer from ocular surface wounds and fear loss of eyesight. A wounded eye can cause extreme pain, swelling, blurred vision, and even vision loss. Such wounds are commonly associated with house hold injuries such as chemical burns from cleaning agents, traumatic impact from items such as falling objects, or removal of a contact lens that has been left in too long. Furthermore, infections and diseases can cause corneal injury. This regenerative bandage could treat these patients with a non-invasive and less expensive procedure that saves millions to the American health care system.
During the course of the Phase I study, Sarentis Ophthalmics demonstrated that it is feasible to use its novel ocular bandage to accelerate the healing of the ocular surface. The physical design of the ocular bandage was successfully optimized and made into a well-shaped device for easy application to the eye and comfort to the eye. The funding provided by the NSF has allowed the company to take a conceptual medical device and convert it into a physical product ready to move into production and human clinical studies. The silk film material used in the ocular bandages provided unique challenges and opportunities in developing devices with the appropriate material properties. Significantly more material work was required during the Phase I award than anticipated in the original proposal. However, through these efforts a number of new silk material processing methods have been developed. Furthermore, greater control and understanding of silk film material properties has been realized, which will ultimately lead to a more capable platform technology with the potential adaption to a number of applications both within and outside the field of ophthalmology. The risk of producing this device and proving its feasibility has been greatly minimized through the work supported by the Phase I award, and with continual support through Phase II the production of the first regenerative silk ocular bandages will be one step closer to reaching the market, and potentially benefiting the millions of Americans afflicted with corneal trauma each year.
