SBIR Phase II: Regenerating Ocular Surface Wounds with Novel Biomaterial

这项小型企业创新研究（SBIR）二期项目将研发出一种加速眼睛表面伤口愈合的绷带。眼部伤口非常痛苦，可能会导致视力丧失，而且可能无法自行愈合。外伤的发生可能是由于家用清洁剂、坠落的物体造成的创伤性撞击或摘掉隐形眼镜。白内障和屈光手术等眼部手术也是角膜损伤的来源。延迟愈合可能会导致疤痕和永久性视力丧失。这个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。绷带就像隐形眼镜。当这种绷带被放在受伤的眼睛上时，它可以减少炎症并促进愈合过程。它是由一种新型生物材料制成的，可以在数小时到数天内“溶解”，为患者提供量身定制的产品。第一阶段完成的工作表明，角膜绷带显著加快了角膜愈合速度。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。该项目的更广泛的影响和商业潜力将帮助每年200万美国人遭受创伤性角膜损伤，以及每年400万美国人接受手术导致角膜受伤。这种角膜伤口引起剧烈疼痛，根据严重程度可能导致失明。这种新的眼角膜绷带加速角膜愈合，并附着在眼睛表面，以帮助减轻疼痛。这种绷带价格低廉，可以降低角膜创伤治疗的成本，从而为美国医疗保健系统节省数百万美元，同时还可以扩大护理点环境（即诊所、家庭使用、敌对环境）。生产完全可以大规模扩展，并且可以像隐形眼镜一样轻松包装和分发。此外，眼绷带是一项创新技术，获得专利，是医疗设备行业的新产品。

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.