RegeneRx reports good results for small investigation of ophthalmic wound-healing drug

BETHESDA, Md. — RegeneRx Biopharmaceuticals has successfully treated four neurotrophic keratitis patients who had non-healing eye ulcers with a sterile eye drop formulation of Tß4 under a compassionate use investigational new drug application, the company announced in a press release.

The company is developing the drug, called RGN-259, for treating ophthalmic wounds and related disorders.

RGN-259 was applied to corneal ulcers that had not healed for at least 6 weeks and for up to several months. By treatment day 28, eye ulcers had either healed completely or demonstrated significant improvement in all four patients, according to the release.

Thirty days after the treatment, ulcers had completely healed or remained healed; those that had demonstrated significant improvement continued to improve after treatment had ended.

RGN-259 was well-tolerated with no drug-related adverse events, the release said.

"In addition to improved healing, the treated eyes appeared much 'quieter' (less inflammation) and patients reported that their eyes felt much better. If necessary, we will extend the treatment regimen for the next two patients to see if we can achieve complete healing in cases where it may take longer than 28 days," Steven P. Dunn, MD, a corneal specialist and the sponsor and principal investigator of the investigational new drug application, said in the release.