R-Tech Ueno announces completion of Phase II clinical study of UF-021 for retinitis pigmentosa

We are pleased to announce that the Phase II clinical study of UF-021, product name Ocuseva (TM), which we are developing as a therapeutic drug for retinitis pigmentosa, has been completed.

Retinitis pigmentosa is an intractable disease where therapeutic drugs or therapeutic methods have not been established yet. When the disease of retinitis pigmentosa progresses, the visual field narrows irreversibly and furthermore, in the late stage, they may suffer from severe visual loss or even blindness. The Phase II clinical study (this study) was conducted to investigate the possibility of improvement of the visual function in the central part of the retina with UF-021 (product name Ocuseva (TM)) in patients whose progression of retinitis pigmentosa was in the mid-stage to the late stage.

This study was a multi-center, randomized, double blind, 3 groups parallel, placebo controlled study conducted based on the Good Clinical Practice (GCP). The groups where the patients placed two dose of UF-021 (Ocuseva (TM)) eyedrops for 24 weeks respectively were compared with the placebo eyedrops (eyedrops without any pharmacological agent) group. The number of enrolled patients was 112.

As a result, it was revealed that UF-021 (Ocuseva (TM)) shows improvement in the visual function dose-dependently in both visual field test and subjective findings. Furthermore, although there was an irritation upon instillation, there were no severe adverse effects.

The study data is currently being analyzed and will be presented at academic conferences and also released through other channels.