Conventional ocular drug delivery approaches have notable clinical limitations: eye drops achieve only 1%-5% bioavailability, while intravitreal injections carry a 0.01%-0.1% risk of endophthalmitis. As a minimally invasive delivery technology that overcomes the bottlenecks of traditional administration, ocular microneedles can significantly improve drug bioavailability and extend sustained release, showing promising advantages in preclinical studies. Focused on clinical needs, this review systematically summarizes the classification, preclinical evidence, and clinical translation potential of ocular microneedles, outlines their scope of application and efficacy characteristics, analyzes potential risks and translational bottlenecks, and proposes targeted implementation strategies. Currently, this technology still faces challenges such as insufficient puncture precision and insufficient long-term ocular safety data in humans. There is an urgent need to establish an ophthalmology-specific safety evaluation system, improve approval procedures and quality control standards, and prioritize the clinical translation of ocular-surface microneedles ,so as to provide accessible, minimally invasive treatment options for chronic and refractory ophthalmic diseases.

内蒙古自治区重点研发和成果转化计划(社会公益领域)项目(No.2025YFSH0048); 内蒙古医学科学院公立医院科研联合基金科技项目(No.2025GLLH0070)