SBIR Phase II: Regenerating Ocular Surface Wounds with Novel Biomaterial

这个小型企业创新研究（SBIR）第二阶段项目将产生一种绷带，可以加速眼睛表面的伤口愈合。眼睛伤口非常疼痛，可能导致视力丧失，并且可能无法自行愈合。家庭清洁剂、坠落物体造成的创伤性撞击或摘除隐形透镜可能会导致创伤。 眼科手术，如白内障和屈光手术，也是角膜损伤的来源。延迟愈合可能导致疤痕和永久性视力丧失。该项目将导致第一个可生物降解的“绿色”角膜绷带，加速角膜愈合。 绷带像隐形透镜。 当这种绷带放在受伤的眼睛上时，它可以减少炎症并刺激愈合过程。 它是由一种新型生物材料制成的，可以编程在几小时到几天内“溶解”，为患者提供定制的产品。从第一阶段完成的工作表明，角膜绷带显着加快角膜愈合速度。 在第二阶段，进一步的开发将为人体临床试验做好准备。第二阶段的结果将产生最终的产品设计、质量体系实施和GMP生产工艺的初步开发。该项目更广泛的影响/商业潜力将帮助每年遭受角膜创伤的200万美国人，以及每年接受手术导致角膜受伤的400万美国人。这种角膜伤口会引起剧烈的疼痛，并可能导致失明，这取决于严重程度。 这种新的眼部绷带加速角膜愈合，并粘附在眼睛表面，以帮助减轻疼痛。绷带是廉价的，并且将导致用于治疗角膜创伤的较便宜的程序，从而为美国医疗保健系统节省数百万美元，同时允许护理点环境（即，诊所、家庭使用、恶劣环境）的扩展。 生产完全可扩展到大批量，并且可以以与接触透镜类似的方式容易地包装和分配。 此外，眼部绷带是一项创新技术，获得专利，是医疗器械行业的新技术。

This Small Business Innovation Research (SBIR) Phase II project will result in a bandage that accelerates wound healing to the surface of the eye. Eye wounds are extremely painful, can cause vision loss, and may fail to heal on their own. Trauma may occur due to household cleaning agents, traumatic impact from a falling object, or removal of a contact lens. Ocular surgeries, such as cataract and refractive surgeries, are also sources for corneal injury. Delays in healing may lead to scarring and permanent visual loss. This project will lead to the first biodegradable "green" corneal bandage that accelerates corneal healing. The bandage resembles a contact lens. When this bandage is placed on a wounded eye it reduces inflammation and stimulates the healing process. It is made of a novel biomaterial, which can be programmed to "dissolve" within hours to days providing patients with a tailored product. Completed work from Phase I demonstrated the corneal bandage significantly accelerated corneal healing rate. During Phase II further development will ready the product for human clinical trials. Results from Phase II will produce the final product design, quality system implementation, and initial development of a GMP manufacturing process.The broader impact/commercial potential of this project will help the 2 million Americans that sustain traumatic injuries to the cornea each year, and the 4 million Americans that undergo surgery annually leaving the cornea wounded. Such corneal wounds cause intense pain and may lead to blindness depending on the severity. This new eye bandage accelerates corneal healing and adheres to the surface of the eye to aid in alleviating pain. The bandage is inexpensive and will result in a less expensive procedure for treating cornea trauma resulting in millions in savings to the American health care system, while allowing for the expansion of the point of care environments (i.e. clinic, home use, hostile environments). Production is fully scalable to large quantities, and can be easily packaged and distributed in a similar fashion as a contact lens. Furthermore, the eye bandage is an innovative technology, patented, and new to the medical device industry.