YD Life Science said it got the U.S. Food and Drug Administration’s go-ahead Tuesday to start a phase 2a trial for YD-312, a therapy that treats a complication of diabetes that affects the eye called diabetic macular edema.
Diabetic macular edema (DMA) refers to the accumulation of fluid in the macula, which mostly controls a person’s ability to see. The condition is often caused by diabetic retinopathy, which damages blood vessels in the retina and causes vision impairment.
The number of diabetes patients suffering from eye diseases has been increasing every year with the global market size for DME therapies to reach 4.6 trillion won by 2019, the company said.
YD’s therapy, based on “sound” preclinical trial results, is now on the fast-track for a global - not domestic - launch with the FDA approval, YD Life Science said.
“The approval of the phase 2a clinical trial of the therapy, developed through only domestic technology, may lay the cornerstone as an example of a diabetic macular edema therapy that became a global new drug through international clinical trials,” the company wrote in a statement.
YD noted that it would begin the clinical trials in the U.S. in the first half of this year, having already selected a contract research organization. The therapy is also being tested in phase 2 trials at 11 Korean hospitals.
YD Life Science is a Korean pharmaceutical that specializes in new drug development, having merged with diagnostic company Youngdong Medical Inc in 2014 and acquiring leading medical equipment distributor Samil Pharmacy and Trading in 2016 to self-supply research & development costs for new drugs, according to the firm.
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