Proparacaine

The analgesic efficiency of ocular surface procedures directly affects patient compliance with ophthalmic examinations and minor surgeries. As a typical amide local anesthetic, proparacaine blocks sodium channels on nerve cell membranes to reversibly inhibit the conduction of nerve impulses. It takes effect in only 20 seconds, with an analgesic effect lasting 15 to 20 minutes, and has a much lower risk of corneal epithelial damage than similar local anesthetics. It is widely used in clinical practice for surface anesthesia in ophthalmic procedures such as intraocular pressure measurement, conjunctival scraping, corneal foreign body removal, and phacoemulsification for cataracts. Its applicable population covers adults and pediatric patients who need to cooperate with ophthalmic examinations, and it is currently one of the basic medications in the field of ophthalmic local anesthesia.

The global proparacaine market size was approximately USD 210 million in 2023, with a compound annual growth rate of 3.8% from 2019 to 2023. The core growth drivers come from the steady increase in the global volume of ophthalmic diagnosis and treatment and the expansion of demand for outpatient procedures related to myopia prevention and control. The Chinese market accounts for about 17% of the total global market size. The current competitive landscape is characterized by the dominance of originator products and the gradual supplementation of generic drugs. Three domestic enterprises have already obtained preparation approvals, and the product has not yet been included in the centralized procurement-related drug list, leaving certain market space for generic drug substitution in the future.

The originator enterprise of proparacaine is Alcon, with the originator brand name Alcaine®. Its core compound patent expired worldwide in 1996. The main dosage form of the originator product on the market is proparacaine hydrochloride eye drops, with a specification of 0.5% (15ml:75mg, 10ml:50mg). This dosage form has been included in the FDA Reference Listed Drug Catalog, and is also included in the *Catalog of Reference Preparations for Chemical Drugs* of China. In terms of domestic API registration, the CDE platform has publicly announced 3 registration numbers for proparacaine hydrochloride API as of now, 2 of which are in active status. On the preparation side, in addition to the imported originator product, proparacaine hydrochloride eye drops from 3 domestic enterprises have been approved for marketing. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of proparacaine impurity reference standards, with most products available in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products fully meet the compliance requirements of multiple regulations including the Chinese Pharmacopoeia and FDA, and can fully satisfy the R&D needs of API manufacturers in terms of quality research, release testing, and generic drug consistency evaluation.