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RegeneRx expands compassionate use study of ophthalmic wound-healing drug
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BETHESDA, Md. — RegeneRx Biopharmaceuticals has announced that it will terminate a small proof-of-concept clinical trial of an eye drop formulation of Tß4 that is currently being conducted among diabetic patients undergoing vitrectomy.
Instead, RegeneRx plans to focus its efforts on a compassionate use study of the drug, called RGN-259, for treating patients with non-healing corneal ulcers, according to a press release from the company.
This follows the company's November announcement that RGN-259 had successfully treated four patients with non-healing eye ulcers for 28 days under a compassionate use investigational new drug application. Accordingly, Steven P. Dunn, MD, the principal investigator holding the compassionate use investigational new drug application, has sought permission from the Institutional Review Board to expand patient enrollment to include 10 patients, to allow a longer treatment period if necessary and to include patients with punctate keratitis.
The patients will be evaluated for both corneal healing and improved visual acuity, the release said.
The double-masked, placebo-controlled, phase 2 vitrectomy trial now slated for termination had been experiencing a delayed enrollment due to a decrease in vitrectomy procedures in the U.S. However, the trial has completed patient treatment with the lowest dose of RGN-259, and all patients will be evaluated as part of the trial closure, which the company expects to take approximately 60 days to complete. There have been no reported drug-related adverse events to date, the release said.