ReGenTree, the US joint venture of clinical-stage drug development company RegeneRx, has obtained the US Food and Drug Administration (FDA) approval to initiate its second Phase III clinical trial of RGN-259 to treat dry eye syndrome (DES).
ReGenTree is a joint venture company between RegeneRx and Korean biopharmaceutical company GtreeBNT.
RGN-259 is a Tβ4-based sterile and preservative-free eye drop developed to treat dry eye and neurotrophic keratitis (NK), which is a persistent corneal defect caused by diabetes and herpes zoster virus among other pathologies.
The second Phase III trial will be designed as a double-masked, placebo-controlled clinical study expected to enrol about 500 patients.
GtreeBNT president and CEO Won Yang said: "The FDA has strict criteria for approval of new drugs for the treatment of dry eye syndrome.
“Since the FDA has accepted ReGenTree's clinical development plan and Phase III protocol based on the results of our previous phase IIb/III trial, if our second Phase III trial is successful we believe ReGenTree may be able to submit an NDA based on the results of these two studies.”
Yang further stated that ReGenTree is intending to complete the Phase III trial by the end of next year aligned to the development plan, and is also aiming to apply for the new drug application (NDA) from FDA in 2018.