Session Title: New Drug Treatment and Technology II
Session Date/Time: Sunday 20/09/2015 | 09:00-10:30
Paper Time: 10:12
First Author: : G.Querques FRANCE
Co Author(s): : F. Darvizeh E. Souied
PURPOSE:Intravitreal steroids are known to be effective in the treatment of diabetic macular edema (DME) and there are a number of new intravitreal inserts, including dexamethasone implant (DEX) and fluocinolone acetonide intravitreal implant (FAc), approved for the treatment of DME in Europe. There is very limited data available on the dosing regimen for DEX which is reflected by the fact that in 2014 over 22% of DEX prescriptions were shown to be off-label in France. The current work was developed to evaluate: i) the average number of DEX treatments per year; and, ii) the time interval between DEX implants.
Results are presented from the analysis of 3 independent studies. These were conducted concurrently and were compared to the results of two studies, MOZART and BEVORDEX, that assessed the real-life usage of DEX.
Study 1 involved 111 ophthalmologists and assessed DME prescriptions. During the course of therapy, the number of injections per year and the interval between 2 successive injections were measured 2.3 and 4.8 month respectively. In study 2, the survey conducted was performed in retail pharmacies with 570 prescriptions; the mean follow-up period was 13.7 months, and 2.3 DEX implants were administered per year with an interval of 5.2 month. In study 3 (French Social Security), 114 patients were initially identified and among them 15 Patients were dispensed with DEX. During 25 months of follow-up, 2.5 DEX in average were injected per year with 4.7 month interval. The results were compared with MOZART study and BEVORDEX trial, which reported on the usage of DEX implants in DME on an as needed basis. The results show that there was a good agreement between studies with the average number of DEX implants ranging between 2.3 and 2.7 injections per year, and the time interval between two DEX treatments ranging between 4.0 and 5.2 months.
The outcomes of these 3 independent studies show very similar results. The average number of DEX implants per year was 2.4 (2.3-2.5) and the time interval between treatments, over a 19.4 month period, was 4.9 months (4.7-5.2). These data support the need for a study to evaluate the optimal frequency for intravitreal injections of DEX, as was requested by the European Medicine Agency (EMA). In-keeping with the DEX studies submitted to the EMA, analysis needs to determine the number of injections per year and the time between treatments over a 36 month period.