Another Approvable Letter Issued – Alcon for Retaane

An approvable letter was issued by the FDA to Alcon for Retaane 15 mg for the treatment of wet-aged macular degeneration (AMD). 

Approvable letters are issued when the FDA acknowledges that it is inclined to approval given certain conditions to be met by the sponsoring company.    In an interesting way of announcing the news, the company issued a press release with the title "Alcon Receives FDA Decision on Retaane (R) Suspension for Wet AMD"

While many times, the agency’s conditions are quite easily fulfilled, in this case, the FDA is asking for further clinical trials, despite the fact that the drug is currently available in other countries.  The request for further clinical study may throw eventual approval into some doubt since the company’s press release states that there are "no immediate plans to conduct a new study of RETAANE(R) suspension for the treatment of wet AMD, due to the difficulty of recruiting patients for such a study in light of other treatments currently available."

Nevertheless, the company states that it will go on with a study that just finished recruiting to study the ability of the drug to reduce progression of dry to wet AMD.   

This entry was posted in Uncategorized. Bookmark the permalink.