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@article{207186,
        author = {Kalyani Ghuli and Bhagyshree shete and Aditya Yelure and Prajakta Pakhare and Maithili Shinde},
        title = {Nanomedicine for Ocular Drug Delivery: From Bench to Bedside—Recent Advances, Clinical Translation, Patents and Future Perspectives},
        journal = {International Journal of Innovative Research in Technology},
        year = {2026},
        volume = {13},
        number = {3},
        pages = {409-428},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=207186},
        abstract = {Ocular nanomedicine has emerged as a promising strategy to overcome the eye’s formidable barriers (tear film, cornea, blood–retina barrier) that limit conventional therapies. Recent years (2021–2026) have seen numerous new formulations—liposomes, polymeric nanoparticles (NPs), dendrimers, micelles, nanoemulsions, hydrogels, implants and gene-delivery vectors—designed to improve drug solubility, retention and targeting in the eye. Several products have been approved or advanced into late-stage trials: for example, the FDA-approved MPP-based eyedrop Eysuvis (loteprednol nanomicelles) for dry eye (2021), and late-phase trials of extended-release intravitreal agents (e.g. Kodiak’s KSI-301) showing significantly fewer injections for wet AMD. At the same time, many innovative carriers (e.g. dendrimer-drug conjugates, AAV/nonviral gene vectors, and in-situ-forming hydrogels) have demonstrated encouraging preclinical efficacy for retinal diseases. Despite these advances, clinical translation remains challenging. Key hurdles include the eye’s unique pharmacokinetics (rapid clearance, compartmentalization) and stringent safety requirements. Regulatory pathways are complex, as many ocular nanomedicines blur the line between drugs and devices (e.g. sustained-release implants). Manufacturing also poses scale-up difficulties, since nanoparticle properties (size, charge, drug-loading) can vary with even minor process changes. The patent landscape reflects intense activity (dozens of filings by academia and industry in 2021–2026) – key examples include Waterford Institute’s lipid nanoparticle and University of Córdoba’s lipid-NP carriers. Major gaps remain: there are few robust in vivo ocular models for human diseases, and many promising preclinical outcomes have failed to translate (e.g. some neuroprotective approaches) due to model mismatch. Regulatory guidelines are still evolving for nanomedicines; for instance, no unified standards exist for ocular nanotoxicity testing. Looking forward, integrating AI-driven design (for optimized nanoparticle formulations and personalized dosing) and gene/RNA therapies into ocular nanocarriers is a key frontier. Collaborative initiatives to define standard PK/PD assays, and early regulatory engagement, are recommended to accelerate safe translation. Below we review the recent literature in detail and provide recommendations for future development.},
        keywords = {Nanomedicine; Ocular drug delivery; Nanocarriers; Polymeric nanoparticles; Lipid-based nanoparticles; Nanoformulations; Retinal drug delivery; Corneal permeability; Blood–retinal barrier; Sustained drug release; Clinical translation; Regulatory challenges; Nanotoxicity; GMP manufacturing; Emerging ophthalmic therapies; Personalized medicine.},
        month = {August},
        }