Next-generation polymer-based nanofiber ocular inserts: fabrication innovations, therapeutic applications, regulatory...

The intricate architecture and physiology of the eye present ocular drug delivery with a significant challenge, resulting in restricted drug absorption and an insufficient therapeutic impact. Conventional delivery systems, however, fail to maintain an effective drug concentration over time, resulting in inadequate patient compliance and suboptimal treatment outcomes. Nanofiber-based ocular inserts have emerged as a viable alternative formulation for prolonged drug release, offering enhanced bioavailability and improved patient compliance. The current article provides a comprehensive analysis of the fabrication techniques for nanofiber-based ocular inserts, with particular emphasis on electrospinning and other innovative technologies. The article discusses the release mechanisms and their applications in various ocular diseases. Applications extend further to the care of ocular infections, glaucoma, retinal disorders, dry eye, and the regeneration of ocular tissue. Critical elements such as biocompatibility, immunological response, sterilization, and long-term stability, together with several evaluation methodologies and in vivo models, are examined. Product and process development considerations, including commercialization potential and scale-up, are discussed with a focus on market trends. Lastly, a regulatory perspective, along with future directions such as gene delivery, smart drug release, and tailored therapy, is discussed, highlighting the transformative potential of nanofiber technology in ophthalmology.