In silico trials in ocular drug development: a new frontier in ophthalmology.

Introduction: In silico trials represent an unprecedented opportunity for ocular drug development. These trials not only promise significant reductions in costs and development timelines but also meaningful improvements in both patient safety and compliance.

Areas covered: This critical perspective gives discussion to the value of in silico trials for novel ocular drug discovery and development. Discussion includes the potential that these trials hold and the challenges that need to be addressed.

Expert opinion: The ophthalmic community stands at a critical juncture, where transitioning from traditional drug development paradigms to more integrative approaches, including computational methods, may profoundly reshape clinical practice. Nevertheless, there a several important limitations that must be overcome; these limitations include dependency on the quality and completeness of input data, accounting for complex biological systems, particularly in ophthalmology, and the variability in patient responses due to genetic, environmental, or lifestyle factors. The issue of silico model validation is also important, especially where the extensive real-world clinical data is not available for comparison. Another important concern is the limited regulatory acceptance of in silico trials to date while standardized guidelines and validation frameworks are still in development. All these issues will need to be addressed for future meaningful progression in the field.