Eye drops maker told to carry out clinical tests, submit results in 3 years

China Food and Drug Administration has urged Zhejiang Shapuaisi Pharmaceutical to start testing the clinical effectiveness of its controversial eye drops and submit results to the authority in three years, thepaper.cn reported on Wednesday.

DXY.COM, a popular medical advice website, recently posted an article via its official micro blog saying many patients did not seek proper treatment because of company’s adverts claiming its eye drops could prevent and cure cataracts.

In a notice published on its official website on Wednesday, the CFDA asked the Food and Drug Administration of Zhejiang province to ask the company to carry out tests on its bendazac lysine eye drop product named Shapuaisi.

The notice requires an evaluation report on Shapuaisi to be submitted to the center for drug evaluation in three years.

The notice also said that the advertisement of the product should be in strict accordance with the drug’s content. Exaggerations that may mislead consumers are not allowed.

"Currently there is no medicine that can effectively prevent or cure cataract," Cui Hongping, director of ophthalmology of the East Hospital affiliated to Shanghai Tongji University, told thepaper.cn. He said all eye drops and oral medicine available in the market, including Shapuaisi, are not effective to treat cataract.

Cui is one of the domestic experts that first questioned the effectiveness of Shapuaisi. In 2013 he published an article on social media criticizing the exaggeration and misguidance of Shapuaisi.

"Some cataract patients I know have kept using Shapuaisi for about two or three years, and their crystalline lenses are getting worse, from slightly opacious, to medium, and to serious. They came for surgery only after a minor disease became a serious one," said Cui.

He also said that operation is the only way to treat cataract.