Ocugen Starts Phase III Trial of OCU300 for Ocular Graft Versus Host Disease

July 6, 2018: By Jon Swedien

Ocugen has initiated the first of two Phase III clinical trials of OCU300 for the treatment of ocular discomfort and redness in patients with ocular graft versus host disease (oGVHD), the company announced July 2.

The US FDA accepted Ocugen’s investigational new drug (IND) application for OCU300 in October 2017.

An autoimmune condition, oGVHD is a severe ophthalmic comorbidity that affects about 60 percent of patients who undergo allogeneic bone marrow transplant. It is characterized by painful, dry, tearless eyes and potential ocular scarring. There is no approved treatment.

OCU300 consists of FDA-approved brimonidine tartrate formulated in a proprietary nanoemulsion based on Ocugen’s patented OcuNanoE technology.

Malvern, Pennsylvania-based Ocugen said it is the first company to advance a therapy into a Phase III clinical trial for oGVHD. Also, OCU300 is the only product candidate the FDA has granted orphan drug designation for oGVHD.

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