Fluorometholone

Glucocorticoids are a core category of drugs for ophthalmic anti-inflammatory therapy. Compared with traditional glucocorticoids, the structural modification of fluorometholone enables it to exert potent anti-inflammatory effects while significantly reducing the risk of adverse reactions of elevated intraocular pressure. Its mechanism of action is to inhibit the synthesis and release of inflammatory mediators and alleviate the inflammatory response of ocular surface tissues such as the conjunctiva and cornea. Clinically, it is mainly used to treat inflammation of the palpebral and bulbar conjunctiva, cornea and other anterior segment tissues sensitive to glucocorticoids, and is also applicable to anti-inflammatory treatment after ocular surgery. It is a commonly used basic drug for clinical ophthalmic inflammation management.

At present, the global market size of fluorometholone is approximately USD 230 million, with a compound annual growth rate maintained at around 4.2%. The growth drivers mainly come from the continuous increase in the prevalence of ocular surface inflammatory diseases such as dry eye and allergic conjunctivitis, as well as the year-on-year increase in the volume of ophthalmic surgeries. In the domestic market, the original research product still accounts for more than 60% of the market share. With the advancement of the consistency evaluation of generic drugs, fluorometholone eye drops from 3 domestic enterprises have passed the consistency evaluation. The implementation of the centralized procurement policy has also promoted a significant improvement in drug accessibility.

The original research enterprise of fluorometholone is Japan's Santen Pharmaceutical, with the trade name "Fluoron". The core compound patent expired in 2002 in major markets such as Japan and the United States, and all relevant patents in China have also expired. At present, the main dosage form approved for the original research product is eye drops, with specifications including 0.1% (5ml:5mg) and 0.02% (5ml:1mg). It has been included in the *Catalogue of Reference Preparations for Chemical Drugs* of China and is also listed in the FDA Reference Preparations Catalogue. In terms of domestic API registration, there are currently 4 fluorometholone API registration numbers in the "A" (approved for use in marketed preparations) status. 7 domestic manufacturers have obtained marketing approval for fluorometholone eye drops, among which 3 have passed the consistency evaluation. (Data as of November 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for fluorometholone API, with most products in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products comply with the regulatory requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can provide stable reference standard support for pharmaceutical enterprises in generic drug research and development, quality research and consistency evaluation work.