When is 0.01% Atropine Sulfate Eye Drops (EIKANCE) expected to be on sale?

0.01% Atropine Sulfate Eye Drops (EIKANCE), as a low-concentration atropine product commercialized overseas earlier, has always attracted the attention of domestic parents and ophthalmology practitioners. The drug is launched by Australia's Aspen Pharma and has been approved by the Australian TGA in 2021 for slowing the progression of myopia in children. After being launched on the market, it has entered clinical prescription channels in Australia, New Zealand and other regions. Due to its preservative-free, single-dose packaging design and global attention in the field of myopia control, it has become one of the most representative prescription eye drops for myopia control in the world.

But in the Chinese market,EIKANCE has not yet received local registration approval. China's drug regulatory authorities have a strict review process for ophthalmic prescription drugs, especially imported drugs, which need to submit complete materials such as stability, quality studies, clinical effectiveness and safety. In addition, the domestic policy orientation of low-concentration atropine mainly focuses on local research and development, so the possibility of imported brands being launched on a large scale in the short term is not high. Currently, public information does not show that EIKANCE has submitted a marketing application in China, and there is no trace of clinical filing information. Therefore, it can be judged that the time for its domestic listing is still uncertain.

At the same time, domestic manufacturers have successfully obtained approval for 0.01% concentration atropine eye drops This means that the domestic low-concentration atropine market has been initiated by local companies. For imported brands, once a product with similar concentration is approved on the market, whether to continue to promote the import strategy will also become a commercial re-evaluation factor for the company. In other words, even if EIKANCE intends to enter China in the future, it will still need to go through a long review window, which may be calculated on an annual basis.

In overseas markets,EIKANCE has established a complete supply system. It can be dispensed with a prescription and sold in individual packages. Its usage habits are gradually accepted by local children's myopia management centers.

Reference materials:https://www.eikance.com.au/