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

这个小型企业创新研究(SBIR)第一阶段项目的更广泛的影响/商业潜力是创造一种商业上可行的、药物释放的隐形眼镜用于治疗青光眼。青光眼是全球不可逆转的视力丧失的主要原因，据估计，2013年全球有100万人受到青光眼的影响。预计到2040年，这一数字将上升到约1.12亿受影响的个人。主要治疗方法是局部滴眼液，患者必须每天至少自我给药一次。这些眼药水提供非常短(几分钟)的药物接触到角膜，90%以上的药物被冲走。此外，患者对这一繁琐的日常应用程序的依从性较差，导致疾病大幅恶化，医疗成本增加。这个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不足，解决药物吸收和患者对靶向和受控药物输送(更好的吸收)和延长佩戴(不那么繁琐，更好的顺应性)的依从性问题。如果成功，这种方法可能成为创新未来眼科治疗的平台技术。拟议的项目解决了目前阻碍青光眼等眼部疾病的充分药物治疗的关键问题。这个SBIR项目的目标是利用特别设计的载药纳米颗粒来实现从隐形眼镜到角膜的几乎恒定的递送速度。这些“智能”纳米粒子将被整合到隐形眼镜配方中，它们将对泪膜的微环境做出反应，从而触发药物的持续释放。与普通滴眼液相比，通过隐形眼镜治疗青光眼有望实现几乎恒定的持续给药速度，更高的生物利用度(远高于5%)，并显著降低意外全身毒性的风险。

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.