Its a complete joke that this didn't get approved the 2nd time in 2011. I've read blogs where the investigators were baffled by the decision that prevented them to practice their art (of taking care of chronic DME subjs). So they want more efficacy and safety data? Really?? how big can it get than a 1000 subj trial with 3 yrs worth of efficacy and safety data. It will get APPROVED this time around IMO. Too much unmet need.
Mkt will be surpised by how quickly this will find favor with the doctors. Anti-VEGF inhibitors do well for newly diagnosed DME sbjs and after a few months the benefits start fading and Iluvient nicely fits in as a 2nd line therapy. Oh yeah, once administered, its good for 3 yrs. Both the blockbuster drgs Lucentis and Eylea are administered once every month and every 2 months respectively. Just google and see how much both ophthalmologists and patients hate that frequent injections to the eye. Yep these 2 drgs earn over billions of dollars each yr.
Mkt is not given much credit to EU launch of Iluvien. This could be due to the stigma from long-acting steroid 'Retisert' approved in the smaller indication of Posterior uveitis. Retisert required a surgery and had apoor safety profile (40% needed surgical glaucoma therapy). FLASH NEWS: Iluvien cuts that risk by 7-8 fold (incidence ~5% needed surgical intervention for glaucoma). So go on and ignore the convenience of a 3-yr long "super convenient' steroid that does better in chronic DME subjects who failed to respond to trts like Lucentis. Mkt hasn't begun to put Iluvien in the same line as Lucentis and Eylea. Once that happens, $ALIM and $PSDV will start getting some attention.
Nope, that is not how they do their review. Its mostly data driven. Alimera conducted a huge trial (close to 1000 subs) and all the safety/efficacy data they will ever need is in there. This whole notion of need another 2 trials to determine efficacy and safety is laughable. I think there is pressure for options in DME (not many approved except for recent Lucentis). FDA may at the time (Nov 2011) been worried about approving Iluvien for Chronic since there was no 1st line therapy approved. Since then they approved Lucentis for DME, so they shud be less worried about use of Iluvien as a front line therapy and approve it as therapy for chronic DME (those that failed Lucentis and other anti-VEGFs).
If you follow Lucentis, its sales have started to come back in the last 2 quarters after getting approved for DME last yr. Eylea is yet to be approved in that indication and is only taking Lucentis mkt share for wet AMD. This confirms that there is a real mkt for approved DME therapies and i feel Iluvien will generate good sales. DME mkt is comparable to wet AMD (per Roche's quarterly call). The mkt opportunity for Iluvien in chronic DME, if embraced by ophthalmologists is decent (~ 1 billion)