28 September 2016
I am writing to you personally today, following comments that we have received and noted, concerning the status of latanoprostene bunod and to assure you that we are fully engaged on the subject following the receipt of the US Food and Drug Administration (FDA) letter by Bausch + Lomb in July.
We are in close discussion with the team at the headquarters of Bausch + Lomb however certain information cannot be publicly disclosed by Nicox at the moment due to the fact that it relates to discussions between Bausch + Lomb and the FDA.
As a reminder, the FDA’s letter did not identify any efficacy or safety concerns with respect to the latanoprostene bunod NDA or any additional clinical trials needed. The FDA comments cited concerns pertaining only to the production site in Tampa, Florida identified during an inspection of this facility.
Bausch + Lomb, who continues to manufacture ophthalmic products daily at the Tampa plant, is currently working with the FDA to resolve and address the concerns and to resubmit the dossier for approval, after which the review by the FDA can take several months.
In any case, we assure you that we will communicate to the market as soon as possible any information relating to the approval of the product by the FDA.
The interests of both parties are aligned by the success of the launch of latanoprostene bunod and we reaffirm our full commitment to advance the regulatory process in view of the future commercialisation of the product.
We thank you very sincerely for your continued support and your patience during a time that is difficult for us as it is for you!