Thymosin β4 significantly improves signs and symptoms of severe dry eye in a phase 2 randomized trial

Sosne G, Dunn SP, Kim C · Cornea

At day 56 the treated eyes had 35.1% less ocular discomfort (p=0.0141) and 59.1% less total corneal fluorescein staining (p=0.0108) than vehicle, with improvements persisting 28 days after dosing stopped.

Population

Adults with severe dry eye, including graft-versus-host-associated disease, at two US sites

Intervention

0.1% Tβ4 eye drops (RGN-259) six times daily for 28 days

Comparator

Vehicle

Limitations

Nine patients — 12 treated eyes against 6 control eyes — at two sites; multiple timepoints assessed, and the effect did not survive scale-up (see nct-02974907).