Table 14

Fluocinolone safety

FAME study (Campochiaro et al)2960Pearson et al43
Number of patients
Ocular adverse events
 IOP at 12 monthsNRNR
 Progression of cataractNRNR
 CataractNRSRFA: 55.9%; SOC: 21.7%
 Transient vitreous floatersNRNR
 Transient subconjunctival haemorrhageNRNR
 Cataract surgerySRFA0.2: 41.1% (74.9% of those without cataract surgery at baseline, 80% at 36 months); SRFA0.5: 50.9% (84.5% of those without cataract surgery at baseline, 87.2% at 36 months); C: 7% (23.1% of those without cataract surgery at baseline, 27.3% at 36 months)NR
 GlaucomaSRFA0.2: 1.6%; SRFA0.5: 2.3%; C: 0.5%NR
 Increased IOPSRFA0.2: 3.2%; SRFA0.5: 3.3%; C: 0%SRFA: 69.3%; SOC: 11.6%
 IOP >30 mm Hg at any point during 36 monthsSRFA0.2: 18.4%; SRFA0.5: 22.9%; C: 4.3%NR
 TrabeculectomySRFA0.2: 2.1%; SRFA0.5: 4.8%; C: 0%NR
 Other glaucoma surgerySRFA0.2: 1.3%; SRFA0.5: 1.3%; C: 0.5%NR
 TrabeculoplastySRFA0.2: 0.8%; SRFA0.5: 2.3%; C: 0%NR
 Vitreous haemorrhageNRSRFA: 40.2%; SOC: 18.8%
 Abnormal sensation in eyeNRSRFA: 37%; SOC: 11.6%
 Macular oedemaNRSRFA: 34.6%
 Eye painNRSRFA: 26.8%; SOC: 15.9%
 Eye irritationNRSRFA: 22%; SOC: 10.1%
 Increased lacrimationNRSRFA: 22%; SOC: 8.7%
 PhotophobiaNRSRFA: 21.3%; SOC: 21.7%
 Blurred visionNRSRFA: 21.3%; SOC: 15.9%
 Vitreous floatersNRSRFA: 21.3%; SOC: 8.7%
Systemic adverse events
 Serious cardiovascular eventsSRFA0.2: 12%; SRFA0.5: 13.2%; C: 10.3%
 PruritusNRSRFA: 38.6%; SOC: 21.7%
 DeathsNRNR
  • IOP, intraocular pressure; NR, not reported; SOC, standard of care; SRFA, fluocinolone.