SBIR Phase I: Contact lens with innovative nanoparticles for multi-week, controlled delivery of glaucoma drugs

该小型企业创新研究（SBIR）I期项目的更广泛影响/商业潜力是创建一种商业上可行的药物释放接触透镜，用于治疗青光眼。青光眼是全球范围内不可逆视力丧失的主要原因，据估计，2013年全球有6400万人患有青光眼。预计到2040年，受影响的人数将增至约1.12亿。主要治疗是局部滴眼液，患者必须每天至少自我给药一次。这些滴眼液提供非常短的（几分钟）药物暴露于角膜的爆发，超过90%的药物被冲走。此外，患者对这种繁琐的日常应用的依从性差导致疾病的严重恶化和医疗费用的增加。该SBIR项目将开发一种新的青光眼治疗标准，克服局部滴眼液的许多缺点，解决药物吸收和患者对靶向和受控药物输送（更好的吸收）和长期佩戴（更少的繁琐，更好的依从性）的依从性问题。如果成功，这种方法可以作为创新未来眼部治疗的平台技术。拟议的项目解决了目前阻碍青光眼等眼部疾病充分药物治疗的关键问题。该SBIR项目的目标是利用专门设计的载药纳米颗粒实现从接触透镜到角膜的接近恒定的递送速率。这些“智能”纳米颗粒将被整合到隐形透镜配方中，将对泪膜的微环境做出反应，引发药物的持续释放。与普通滴眼液相比，通过接触透镜治疗青光眼有望实现以接近恒定速率的可持续药物递送，更高的生物利用度（远高于5%），并且大大降低了非预期全身毒性的风险。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to create a commercially feasible, drug-releasing contact lens for treatment of glaucoma. Glaucoma, the leading cause of irreversible vision loss worldwide, was estimated to affect 64 million people world-wide in 2013. This is expected to rise to approximately 112 million affected individuals by 2040. The primary treatment is topical eye drops that patients must self-administer at least once per day. These eye drops provide a very short (a few minutes) burst of drug exposure to the cornea, with more than 90% of the drug being washed away. Furthermore, poor patient compliance with this tedious daily application accounts for substantial worsening of disease and increased healthcare costs. This SBIR project will develop a new glaucoma treatment standard that overcomes the many shortfalls of topical eye drops, resolving issues of drug absorption and patient compliance with targeted and controlled drug delivery (better absorption) and extended wear (less tedious, better compliance). If successful, this approach could serve as a platform technology for innovating future ocular treatments.The proposed project solves key issues that currently hinder the adequate pharmaceutical treatment of ocular diseases such as glaucoma. The goal of this SBIR project is to utilize specially designed drug-carrying nanoparticles to achieve a near constant rate of delivery from a contact lens to the cornea. These "smart" nanoparticles, which will be integrated into contact lens formulations, will respond to the microenvironment of the tear film to trigger a sustained release of the drug. Comparing with the common eye drops, the glaucoma treatment via contact lens is anticipated to achieve a sustainable drug delivery at a near constant rate, higher bioavailability (much higher than 5%), and with substantially reduced risk of unintended systemic toxicity.