World Drug Delivery Summit

Biography

Biography: Michael O Rourke

Abstract

The estimated number of people visually impaired in the world is 285 million, 39 million blind and 256 million having low vision. 65% of people visually impaired and 82% of all blind are 50 years and older. There have been major advances in recent years in developing and launching new sustained release ocular drug delivery systems. However, only a small number have achieved both global regulatory approval and commercial success. Despite the challenges, there remains a significant market opportunity to enhance current products or develop new technologies offering improved treatment options for patients suffering from the major blinding eye diseases. Four major blinding diseases, Age Related Macular Degeneration, Diabetic Retinopathy, Diabetic Macular Edema and Glaucoma, due to their whole or partial impact on the posterior segment of the eye, and their growing market sizes, may offer the most promising opportunities for future ocular drug delivery technologies. They affect large numbers of people and pose significant risk of vision loss and blindness for those affected. Current therapeutic options for these diseases may at best manage the condition, slowing or halting further deterioration or disease progression. New breakthrough treatments would benefit from robust sustained delivery of the drug to the target tissues in the posterior segment and, importantly, enhance compliance of patients with long-term treatment regimens for these chronic diseases, for example, avoiding or reducing the need for frequent injections. These drug-delivery challenges to the posterior segment of the eye, for both small and large molecules provide a significant market opportunity for the development of new therapies based on enhanced drug delivery methods and technologies. Topical eye drop application is still the most common method for treating anterior segment diseases, while intra-vitreal injections are used to manage posterior segment conditions. However, protective ocular barriers and clearing mechanisms necessitate frequent administration, decreasing patient compliance and increasing the risk for adverse effects. Developing novel controlled release systems to efficiently treat both anterior and posterior segment diseases offers great opportunities for new product development. This presentation will summarize important ocular barriers and pharmacokinetics to be considered and will discuss recent delivery approaches with a focus on clinical evaluation, regulatory hurdles, and current products in the pipeline.