Abstract
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Purpose: Although eight pharmacological treatments for dry eye disease (DED) are currently available, the overall burden experienced by patients has not improved substantially, and the number of outpatient visits continues to rise. This study reviews clinical trial outcomes of several recently developed DED therapies to identify potential reasons for this persistent unmet need.
Methods: Publicly available clinical trial data for DED treatments, including lifitegrast (Xiidra), perfluorohexyloctane (Miebo), and acoltremon (Tryptyr), were collected from online sources. Each trial was evaluated with particular attention to inclusion criteria, efficacy endpoints, placebo-control design, and study outcomes.
Results: The design of inclusion criteria and placebo control groups was found to be critical for achieving favorable trial outcomes. However, statistically significant differences between active treatment and placebo did not always translate into clinically meaningful benefits for patients. These findings suggest that substantial unmet therapeutic needs remain in DED management, despite the introduction of new treatment options.
Conclusions: Despite continued advances in DED drug development, DED is likely to remain an area of significant unmet need in ophthalmology. Future therapeutic development should place greater emphasis on meeting patients’ expectations for treatment efficacy, achieving clinically meaningful improvements beyond placebo effects, and prioritizing real-world patient benefit rather than relying solely on statistical significance as a primary measure of success.
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