Stuart Therapeutics' Dry Eye Disease Drug Fails Primary Endpoint in Phase 3 Trial

Stuart Therapeutics has reported that its dry eye disease drug, ST-100 (vezocolmitide), failed to meet the primary endpoint in a recent phase 3 clinical trial. The ophthalmic solution, designed to repair disease-damaged collagen and improve cell health, did not demonstrate a statistically significant increase in tear production compared to the vehicle after 29 days of treatment.

Trial Results and Secondary Endpoints

Despite missing the primary endpoint, Stuart Therapeutics highlighted positive outcomes in secondary measures. The company reported clinically meaningful improvements in fluorescein staining, a method used to examine eye damage, as early as Day 4. Additionally, ST-100 showed a statistically significant improvement in vision relative to placebo on Day 2.

Eric Schlumpf, CEO of Stuart Therapeutics, expressed optimism about the trial's overall results, stating, "While additional study is required, the underlying data and the clinically meaningful results from this trial strongly suggest that ST-100, as the first drug candidate in a novel therapeutic class, can address the critical unmet needs in dry eye disease."

Next Steps and Future Plans

Stuart Therapeutics is not deterred by the primary endpoint miss and plans to seek FDA feedback for the design of an additional phase 3 study. The company aims to keep ST-100 in contention for potential approval, focusing on its rapid onset of action and patient-noticeable effects.

The Florida-based biotech firm developed ST-100 using its proprietary synthesized polypeptide therapeutic platform, which targets specific areas of collagen damage involved in chronic eye diseases. This platform has also produced other promising candidates, including ST-113 for glaucoma, which has been licensed to Glaukos Corporation.