Biotech Values

[DewDiligence]

Macugen phase-3 safety and efficacy:

I’ve extracted more of the Macugen phase-3 data from the presentation slides of Dr. Jordi Monés (see message #655) and have reposted the efficacy table from #651 for convenience. Thus, the following are the most pertinent Macugen data all in one place. Feedback welcomed.

 
 SIZE, 
 DROPOUT RATE 
                Patients  Dropout 
                enrolled   rate     
   
 Macugen (3 doses) 890      8% 
 Placebo           296      8% 
   
   
   
 SERIOUS ADVERSE EVENTS 
 (890 Macugen patients) 
   
 Condition              No. of patients 
    
 Endophthalmitis              12 
 Cataract / lens damage        5 
 Retinal detachment            4 
                              -- 
 All serious adverse events   21 (2.4%) 
   
   
   
 DISEASE SUBTYPES 
 (Same for Macugen and placebo) 
   
 Predominantly classic  27% 
 Minimally classic      35% 
 Occult                 38% 
   
   
   
 EFFICACY 
 (0.3mg best dose) 
   
 Change in lines 
 visual acuity        % of Patients 
 at 1 year         Macugen    Placebo 
                              
 >=+3 (“improved”)    6          2 
 >= 0                33         23 
 > -3 (“stable”)     70         55 
 > -6                90         78