Biotech Values

[pcrutch]

Their data appears to get better over time, the 30 month data still looks good. I guess its a matter of whether you can still trust their data analysis. Apparently analysts at Citigroup and Oppenheimer expect them to obtain marketing approval either in the 4th quarter of 2011, or early 1Q 2012.

http://investor.alimerasciences.com/releasedetail.cfm?ReleaseID=474222

http://bit.ly/a6t4s3

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May 10: New data analysis from FAME trial of Iluvien for DME: Pt vision continues to improve significantly over 30 months. At month 30, an improvement in visual actuity of 15 letters or more was seen in 40% of pts (n=123, p=0.002). Complete 36 month dataset due after trial concludes in Oct 2010. (5)
01/06/2010 08:01:11

Apr 10: Further 24-month data from the FAME PIII study were presented at Angiogenesis 2010 meeting. In patients receiving low dose Iluvien, >50% gained at least 5 letters at 24 months and >75% received only a single administration of Iluvien; > one-third of the one-administration patients gained more than 15 letters at 24 months. Patients receiving low dose Iluvien were also less likely to receive additional treatments for their DME (58.9% of control vs 36.7% of low dose Iluvien patients received laser treatment, and 28.6% vs 12.5% received an off-protocol treatment (intravitreal injection of Kenalog, Lucentis or Avastin or vitrectomy). New safety data showed that patients on low dose Iluvien were more likely to develop glaucoma than control patients (2.7% vs 1.1%) but had lower rates of retinal detachment (0.5% vs 1.6%) and vitreous haemorrhage (2.1% vs 2.7% of control). In the FAME study about 30% of patients had cataract surgery before they entered the trial. Of the remaining patients, those randomized to Iluvien low dose were more likely to develop cataract vs controls (80% vs 45%) and to have cataract surgery (75% vs 23%) [4].
08/04/2010 11:09:48


Dec 09: Phase III trial results: FAME study (trials A & B). Main efficacy outcome is the difference in the % of patients whose best corrected visual acuity (BCVA) improved by 15 or more letters from baseline on the ETDRS eye chart at month 24 between the treatment and control groups. Month 24 analysis using the Full Analysis Set (n=956 in total) in trial A showed statistical significance with 26.8% of the low dose patients having an improvement in BCVA of 15 letters or greater over baseline and 26.0% of the high dose patients having an improvement in BCVA of 15 letters or greater from baseline. In Trial B, the month 24 data showed statistical significance with 30.6% of the low dose patients having an improvement in BCVA of 15 letters or greater over baseline and 31.2% of the high dose patients having an improvement in BCVA of 15 letters or greater from baseline. Intraocular pressure increases of 30mmHg or more were seen in 16.3% of the low dose pts and 21.6% of the high dose pts. Over 24 months, 2.1% of pts needed a trabeculectomy to reduce eye pressure. (3)
24/12/2009 08:10:07