EyeCRO presented data from the first clinical application of its MiDROPS platform technology at the ARVO meeting in Seattle. The Phase 2 study evaluated the effect of 0.1% TL-925 vs Vehicle, dosed twice daily, in 107 patients with moderate to severe dry eye disease (DED) over 28 days.

The data showed MiDROPS capability to safely formulate and deliver lipophilic molecules via topical eyedrops — both TL-925 and the MiDROPS vehicle were safe and well-tolerated. Mean drop comfort score was 2.6 (scale: 0-10) in both the treatment and vehicle Study Eye with the most common treatment-emergent adverse event of low-grade (grade 1) instillation site irritation.

According to the company, this is the first clinical study to establish the critical role of Bruton’s tyrosine kinase in the pathophysiology of DED. TL-925 demonstrated clinically meaningful and statistically significant efficacy (intention-to-treat, N=107) across multiple signs of DED, including Central and Total Corneal Fluorescein Staining (p=0.01 and p=0.034, respectively) and symptoms of DED, Visual Analog Scale - pain, OD4SQ - dryness and burning (p=0.014, p=0.026, and p=0.034, respectively).

For more, see the study results here.