Delivery of therapeutic proteins to ocular tissues: Barriers, approaches, regulatory considerations and future perspectives.

The administration of therapeutic proteins directly to the eye is a major breakthrough in the treatment of several eye conditions. This chapter highlights the crucial significance of ocular therapies because of the widespread occurrence of vision-threatening disorders and the distinct difficulties presented by the eye's architecture and physiological limitations. Therapeutic proteins, known for their exceptional specificity and effectiveness, provide hopeful answers. However, they encounter various obstacles in their ocular distributions like tear film, corneal epithelium, and blood-retinal barrier etc. Formulation techniques and drug delivery technologies, such as nanotechnology, hydrogels, microneedles, liposomes, dendrimers, and polymeric nanoparticles are improving the stability, bioavailability, and targeted administration of proteins. Notwithstanding this progress, obstacles such as protein stability, immunogenicity, and patient compliance endure. Methods to address these challenges include improving permeability, formulating sustained release systems, applying non-invasive delivery techniques, and implementing tailored delivery strategies. Furthermore, it is essential to effectively navigate through regulatory routes, comprehensively grasp market factors, and successfully secure intellectual property to achieve successful commercialization of these new methods.