Issue: December 2021

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December 16, 2021
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First patient in China screened in phase 3 trial of NCX 470 for glaucoma

Issue: December 2021
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The first patient in the Chinese portion of the Denali phase 3 clinical trial, investigating NCX 470 in patients with open-angle glaucoma or ocular hypertension, has been screened, according to a press release from Nicox.

Denali is evaluating the efficacy of NCX 470 ophthalmic solution 0.1% compared with latanoprost ophthalmic solution 0.005% to lower IOP in patients with open-angle glaucoma or ocular hypertension. The study will enroll about 670 patients in the U.S. and China, with U.S. patient enrollment ongoing since November 2020.

doctor eye drops
Source: Adobe Stock

“NCX 470 is one of the key development assets in our pipeline, allowing us to bring an efficacious, novel therapeutic into the Chinese glaucoma market, which is expected to grow exponentially over the next decade,” Victor Liu, CEO of Ocumension Therapeutics, said in the release. “The approach of Nicox in designing a multiregional, U.S.-China phase 3 program has accelerated the development of NCX 470 for us, and we are pleased with the Nicox collaboration on all fronts.”

Nicox previously licensed NCX 470 to Ocumension in China, Korea and Southeast Asia.

The Denali trial is intended to satisfy FDA regulatory requirements as well as China’s National Medical Products Administration. Results are expected in 2023.