RegeneRx Biopharmaceuticals has secured orphan drug designation from US Food and Drug Administration’s (FDA) Office of Orphan Products Development (OOPD) for its drug candidate, Thymosin beta 4 (Tß4), to treat patients with neurotrophic keratopathy (NK).
NK is a serious degenerative disease of the corneal epithelium, the outside layer of the eye, and causes corneal ulceration, perforation, pain and impaired vision.
RegeneRx president and CEO J J Finkelstein said the FDA orphan status offers the company a number of opportunities that would not otherwise have been available.
"It is an important milestone, the result of the significant and growing body of data supporting Tß4’s development for this serious disorder, often caused by the herpes zoster virus and diabetes mellitus," Finkelstein said.
The company said that in a previous physician-sponsored clinical trial with RGN-259, the drug candidate stimulated healing within four to eight weeks in patients with NK who had non-healing corneas for a minimum of six weeks to more than a year.
RGN-259 is the company’s preservative-free, sterile, ophthalmic eye drop whose active ingredient is Tß4.
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So far, the company’s clinical experience shows that RGN-259 is safe, well-tolerated, and significantly improves patient comfort.
The company is mainly focused on the development of a novel therapeutic peptide, Tß4, for tissue and organ protection, repair and regeneration.
At present, the company has three drug candidates in clinical development for ophthalmic (RGN-259), cardiac (RGN-352) and dermal (RGN-137) indications, two strategic licensing agreements in China and the European Union (EU), and has an extensive worldwide atent portfolio covering its products.
Image: The cornea, as demarcated from the sclera by the corneal limbus. Photo: courtesy of Mikael Häggström.