The incidence of ophthalmic diseases is increasing due to complex factors such as aging and diabetes. Major diseases include macular degeneration, diabetic retinopathy, glaucoma, and dry eye. Considering the unique pathophysiological characteristics of ophthalmic diseases, such as the progression rate of the disease, the site of drug action, and the complexity of local administration methods, as well as pharmacokinetic factors, a clinical development strategy that can quantitatively demonstrate treatment efficacy and safety is required.

Given the nature of ophthalmic diseases, an evaluation system that comprehensively considers various indicators, such as precise imaging-based assessments (OCT, fundus photography, etc.), visual acuity and visual field measurements, and patient-reported outcome measures (PROMs), is necessary. When designing clinical trials, the pharmacokinetics of locally administered formulations, the route of administration, and the distribution characteristics of drugs according to eye structure must also be considered.

In the early stages of clinical trials, patient groups are classified and inclusion/exclusion criteria are established, taking into account the progression stage of the disease and heterogeneity of treatment responses. Subsequently, using the latest data-driven approaches such as real-world evidence (RWE), imaging analysis technologies, and biomarker utilization, documents compliant with global regulatory requirements are prepared, and statistical analysis is conducted to support the entire clinical trial process.