For this study, the authors analysed the pooled data from three phase2b / 3 multi-centre randomised controlled trials carried out over three years. Included patients had undergone at least one of the following treatments: 1) systemic therapy (corticosteroid / immunosuppressant for at least three months) 2) two or more subtenon’s injections of steroid in the six months prior to enrolment, or 3) systemic steroid or subtenon’s steroid injection on at least two occasions over the six months prior to enrolment. The treatment arm included 290 eyes that received an implant of 0.59-mg FAI, and the control arm included 351 eyes that were treated with topical / systemic steroids or other immunosuppressants. The patients were followed up at pre-planned intervals over three years. Absolute values of IOP and IOP elevations were measured, as well as the percentage of eyes that required topical treatment or surgical treatment for raised IOP. A greater proportion of eyes in the treatment arm developed IOP rises of 10mmHg and absolute IOP of 30mmHg (65.1% versus 17.1%, hazard ratio (HR) 5.80). Risk factors between the two groups were compared and a younger age, male sex and phakic status were found to be significantly associated with a higher risk of IOP rise, while no such association was shown for race, disease severity at time of enrolment, and location of uveitis. A greater progression in optic disc cupping (significant) and in mean deviation in Humphrey’s Visual Field (non-significant) were also noted in the treatment group over the observation period. This study confirms the high incidence of raised IOP following treatment with FAI. It indicates the need for patient selection for this treatment, and for close follow-up and adequate IOP management to prevent development or worsening of glaucoma. Because of the multi-centre nature of this study, there is likely to have been some variability in the diagnosis and management of glaucoma-related damage.