Causes Of Treatment Discontinuation

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Treatment Discontinuations The discontinuation from a subsequent FAc implant insertion was assumed to be due to one of the following reasons: • A clinically insignificant response to therapy; • Early death; or • Due to other non-clinical reasons Treatment discontinuation secondary poor clinically efficacy is addressed in the model by estimating the percentage of patients achieving a ≥10 letter increase from baseline to month 36 (treatment response). For the chronic DME population, this was determined to be 51.7% of the initial baseline population. Discontinuation in the FAME studies due to early death over the 36-month evaluation period for patients the FAc implant group was 7.2% within the chronic DME population (Table 3). These values…show more content…
The model also incorporated the cost of glaucoma surgery and vitrectomies, which were also reported in the FAME studies. The model considered AEs from intravitreal injections such as endophthalmitis and retinal detachments. The frequency of these events was assumed to be independent of treatment received, and incidence rates were calculated from pooled data from all patients enrolled in the FAME trials. The evaluation did not consider traumatic lens injury and vitreous hemorrhage because it could not be determined if these events were due to the treatment received or the underlying diabetes. The frequency of endophthalmitis and of retinal detachment was also assumed to not be specific to type of treatment received; instead, these episodes were assumed to be associated with the actual administration of the intravitreal injection. The total chronic DME population in the FAME trials (FAc implant and BSC treatment groups combined) received 1,557 intravitreal injections. Furthermore, there were 16 retinal detachment and 3 endophthalmitis events within the chronic DME population, generating an incidence of 1.03% for retinal detachment and 0.19% for endophthalmitis per intravitreal injection (Table 4). Table 4. Incidence of retinal detachment and endophthalmitis per injection. Retinal Detachment Endophthalmitis Total number of events 16 3 Total number of injections 1,557 1,557 Incidence per injections 0.0103 0.0019 Source: Integrated Safety Update:
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