Opatanol (olopatadine hydrochloride) was first authorized in the European Union in May 2002 as eye drops for the treatment of ocular signs and symptoms of seasonal allergic conjunctivitis.
In April 2005, Alcon Labs submitted an application for the extension of the marketing authorization to add a new pharmaceutical form: a nasal spray intended for a new use in the treatment of the symptoms of seasonal and perennial allergic rhinitis.
The company said its decision to withdraw the application was based on commercial reasons, citing its marketing strategy as the reason in a letter to the European Medicines Agency. Alcon Labs also confirmed that there are no ongoing trials of the nasal spray formulation of the drug in the EU, nor any compassionate use programs.
Alcon’s UK subsidiary had better news closer to home back in January, when the Scottish Medicines Consortium advised UK National Health Service (NHS) boards and area drug and therapeutic committees that Opatanol eye drops are accepted for use within NHS Scotland for the treatment of ocular signs and symptoms of seasonal allergic conjunctivitis.