I posted the other day about Alcon's Vexol being in clinical trials with a 2009 NDA expected.
I've been asked why, since this is an already FDA approved corticosteroid which has been on the market for quite some time. The reason for the new clinical trials and new FDA submission is to broaden its indications to specifically include dry eye. As you know topical steroids have been used in dry eye treatment for quite awhile (and Lotemax has been particularly prominent of late) - however, dry eye is an off-label use of topical steroids. Getting FDA approval for a steroid drop specifically for dry eye would mean that the company can market it directly to consumers ala Restasis.