0.1% RGN-259 (Thymosin ß4) Ophthalmic Solution Promotes Healing and Improves Comfort in Neurotrophic Keratopathy Patients in a Randomized, Placebo-Controlled, Double-Masked Phase III Clinical Trial

Sosne G, Kleinman HK, Springs C, Gross RH, Sung J, Kang S · International Journal of Molecular Sciences

Complete healing at four weeks occurred in 6 of 10 treated versus 1 of 8 vehicle patients — p=0.0656, so the primary endpoint did not reach significance. Symptom scores and Mackie disease stage at day 43 (p=0.0467) did favour treatment, and no healed treated eye relapsed.

Population

Patients with stage 2–3 neurotrophic keratopathy and persistent corneal epithelial defects

Intervention

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

Comparator

Vehicle

Limitations

Labelled phase III but enrolled 18 of a planned larger cohort; the registration (NCT02600429) was terminated for a business decision, and the primary endpoint was not met.