Lodoxamide

As a highly prevalent ocular surface allergic disease, allergic conjunctivitis is often not effectively addressed by traditional antihistamine drugs, which fail to simultaneously meet the dual requirements of stabilizing mast cells and inhibiting the release of inflammatory mediators, resulting in a long-standing problem of insufficient treatment adherence in clinical practice. Lodoxamide is an ophthalmic medication belonging to the mast cell stabilizer class. By inhibiting calcium ion influx, it blocks the degranulation process of mast cells and reduces the release of allergic mediators such as histamine and leukotriene. It can be used not only for the prevention and treatment of allergic conjunctivitis and vernal keratoconjunctivitis, but also for relieving uncomfortable symptoms such as ocular itching, conjunctival hyperemia and photophobia. It is applicable to patients with allergic constitution of all age groups, and has good safety profile for long-term use.

The continuously rising global prevalence of allergic diseases drives the expansion of the ophthalmic anti-allergy medication market. Currently, the global market size of lodoxamide-related preparations is approximately USD 230 million, and the compound annual growth rate from 2021 to 2026 is expected to remain at 4.8%. The domestic market is still dominated by the original research product at present, and 3 domestic enterprises have submitted marketing applications for generic drugs. With the advancement of the consistency evaluation of generic drugs, domestic preparations with higher cost-effectiveness are expected to further penetrate the primary medical market in the future, driving the continuous release of demand for upstream API.

The original research enterprise of lodoxamide is Novartis, with the original brand name ALOMIDE. The core compound patent in the US market expired in 2003, and the compound patent in China expired in 2004. The main dosage form of the original research product is 0.1% lodoxamide tromethamine eye drops, with the conventional specification of 5ml:5mg. It has been included in the *Catalogue of Reference Preparations for Chemical Drugs* in China, and is also listed as a reference preparation by the FDA. At present, there is no approved A-status registration number for lodoxamide on the domestic API registration platform, and 2 imported original research eye drops and 1 domestic generic eye drop have been approved for marketing. (Data as of October 2024, please refer to the official website of CDE for the latest information)

In response to the needs of lodoxamide generic drug research and development and quality control, CATO provides a full set of impurity reference standards for this API, covering all categories such as synthesis process impurities and degradation impurities. Most products are in regular stock, and orders placed before 16:00 can be shipped on the same day. All reference standards meet the requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the R&D and production quality control needs at various stages such as impurity research and release testing.