MFDS Cancels Approval of Three Cataract Injection Drugs by Unimed Pharmaceuticals

[Asia Economy Reporter Chunhee Lee] The approval for three cataract surgery adjuvant injection products from Unimed Pharmaceuticals will be revoked.

The Ministry of Food and Drug Safety and the Korea Disease Control and Prevention Agency announced on the 28th that they confirmed non-compliance in quality (sterility test) inspection results for three products, including Unimed Pharmaceuticals' 'UniAlju 15mg (Sodium Hyaluronate)', and will cancel their approval effective from the 4th of next month. Previously, the Ministry of Food and Drug Safety had ordered a temporary suspension of manufacturing and sales and a recall of all products for these three items last month.

The authorities explained that the cancellation of approval is based on epidemiological investigation results related to the recent increase in fungal endophthalmitis cases after cataract surgery, confirming a correlation between the products and the occurrence of fungal endophthalmitis.

The Korea Disease Control and Prevention Agency stated that among 146 cases of fungal endophthalmitis after cataract surgery occurring between September and November last year, 136 cases (93.2%) were confirmed to have used the products in question. Endophthalmitis is an inflammation caused by bacteria or fungi invading the inside of the eye, leading to vision deterioration and loss. It commonly occurs as a complication of cataract extraction or filtration surgery.

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