Is 0.01% Atropine Sulfate Eye Drops already on the market in the country? What was the time and circumstances of its approval for listing?

The original drug of 0.01% atropine sulfate eye drops (EIKANCE) has not yet been launched in the Chinese market and has not been included in medical insurance. Therefore, patients currently cannot purchase the drug through formal channels in the country. Although the drug is not yet available in China, it is already widely available in some international markets, especially the United States and Europe.

The main purpose of atropine sulfate eye drops is to treat the progression of myopia by inhibiting the adjustment function of the eyeball to reduce the growth of the axial length, thereby slowing down the progression of myopia. In some countries, especially in the context of research that has a significant effect on controlling the progression of myopia in children and adolescents, this drug has become one of the effective drugs for treating the progression of myopia.

In the international market, the original drug specification of atropine sulfate eye drops is usually 0.01% 0.3ml 30 tubes, and the price of each box is about 600 more than RMB. This price may vary by country and region. The drug is typically administered as once-daily eye drops and is highly effective with fewer side effects, but its higher price remains a challenge for many patients.

Compared with original drugs, generic drugs are more affordable. For example, the specifications of generic drugs produced in India are 0.01%w/v*5ml, and each drug is sold for about tens of RMB. Although generic drugs are more competitively priced, their quality and effectiveness are often similar to the brand-name drugs, meeting the needs of more patients.

Since it has not yet been approved for marketing in China, if patients want to use atropine sulfate eye drops, they may need to purchase drugs overseas. As the therapeutic effect of this drug is gradually recognized, its future approval and marketing in China is still an expected process.

Reference materials:https://www.medsafe.govt.nz/profs/datasheet/e/EikanceEyeDrops.pdf