Treatment of Open-Angle Glaucoma and Ocular Hypertension with Preservative-Free Tafluprost/Timolol Fixed-Dose Combination Therapy: UK and Ireland Results from the VISIONARY Study.

INTRODUCTION: Reducing intraocular pressure (IOP), the only modifiable risk factor for open-angle glaucoma (OAG), is important for the preservation of vision and slowing of disease progression. Preservative-free tafluprost (0.0015%)/timolol (0.5%) fixed combination (PF Taf-T FC) is an approved combination therapy for OAG treatment. The VISIONARY study aimed to evaluate the effectiveness and tolerability of PF Taf-T FC in real-world clinical settings. Here, we present the results from the United Kingdom (UK) and Ireland. METHODS: This observational, multicentre, European, prospective study recorded data during routine clinic appointments on the use of PF Taf-T FC for the treatment of OAG and ocular hypertension (OHT) in patients whose disease was insufficiently controlled on a prostaglandin analogue (PGA) or beta blocker monotherapy or who did not tolerate these medications. Mean change in IOP, symptom severity, changes in clinical signs, and tolerability were investigated over 6 months. RESULTS: Eighty-two patients were recruited in the UK and Ireland. After 6 months of PF Taf-T FC treatment, mean IOP was significantly reduced from 22.0 to 16.2 mmHg in the UK group and from 18.6 to 14.1 mmHg in the Ireland group. In the UK (65 patients), 49 adverse events (AEs) were reported, of which 3 were serious. No AEs were reported in the Ireland group (17 patients). Overall, 91.9% of UK physicians reported PF Taf-T FC treatment to be the same or better than prior medication for improving clinical signs; 90.0% of UK patients reported PF Taf-T FC treatment to have good or very good tolerability. CONCLUSIONS: Treatment with PF Taf-T FC resulted in significant reductions in mean IOP over 6 months. Patients and physicians reported that treatment was well tolerated. These data demonstrate real-world efficacy of PF Taf-T FC for the treatment of OAG and OHT in routine clinical practice in the UK and Ireland. TRIAL REGISTRATION: European Union electronic Register of Post-Authorisation Studies (EU PAS) register number, EUPAS22204.

Anatomical and functional outcomes following switching from aflibercept to ranibizumab in neovascular age-related macular degeneration in Europe: SAFARI study.

BACKGROUND/AIMS: Prospective data on switching anti-vascular endothelial growth factors in patients with neovascular age-related macular degeneration (nAMD) who have previously shown no/partial response are limited. This prospective study assessed the effect of switching from aflibercept to ranibizumab on anatomical and functional outcomes in patients with persistent/recurrent disease activity. METHODS: SAFARI (NCT02161575) was a 6-month, prospective, single-arm study conducted in the UK and Germany. Patients, meeting strict eligibility criteria for one of two subgroups (primary treatment failure or suboptimal treatment response), received 3 monthly intravitreal ranibizumab injections (0.5 mg). Thereafter, ranibizumab was administered pro re nata at monthly visits. The primary endpoint was change from baseline (CfB) to day 90 in central subfield retinal thickness (CSRT). Best-corrected visual acuity (BCVA) and retinal morphology parameters were assessed. RESULTS: One hundred patients were enrolled (primary treatment failure, 1; suboptimal treatment response, 99). In the overall population, there was a significant CfB in median CSRT of -30.75 µm (95% CI -59.50,-20.50; p<0.0001) to day 90. Improvements were also observed in other quantitative and qualitative optical coherence tomography parameters. In Early Treatment Diabetic Retinopathy Study letters assessed by category, 55% and 59% of patients gained 0-≥15 letters versus baseline at day 90 and day 180, respectively. However, mean improvements in BCVA (CfB) to each time point were small (≤2 letters). No new safety signals were identified. CONCLUSION: Switching from aflibercept to ranibizumab led to a significant improvement in CSRT, with ~60% experiencing stabilised/improved BCVA. Therefore, patients with nAMD who have shown a suboptimal response to aflibercept may benefit from switching to ranibizumab.

Resource Use and Real-World Outcomes for Ranibizumab Treat and Extend for Neovascular Age-Related Macular Degeneration in the UK: Interim Results from TERRA.

INTRODUCTION: Ranibizumab is an inhibitor of vascular endothelial growth factor-A (anti-VEGF) approved for the treatment of neovascular age-related macular degeneration (nAMD). The treat and extend (T&E) regimen can potentially reduce the burden of clinic visits compared with a pro re nata (PRN) regimen. Retrospective, interim analyses of clinical effectiveness, treatment and resource use patterns were conducted using real-world data in England and Wales from the TERRA study. METHODS: Two cohorts, those switching from a PRN to a T&E regimen ('prior PRN') and those initiating ranibizumab on the T&E regimen as their first anti-VEGF therapy ('anti-VEGF-naïve') were enrolled in TERRA. Retrospective clinical assessments were gathered from medical records, while resource use patterns were collected via an operating cost questionnaire completed by each study site. RESULTS: At the interim analysis cut-off date (15 November 2016), 11 sites had enrolled 145 patients (prior PRN: n = 110; anti-VEGF-naïve: n = 35). Mean change from baseline (date of first injection) in visual acuity and central subfield retinal thickness to 12 months was +7.6 Early Treatment Diabetic Retinopathy Study letters [95% confidence interval (CI) 2.8, 12.4; p = 0.003; n = 27] and -67.7 µm (95% CI -106.5, -28.9; p = 0.001, n = 29), respectively, in the anti-VEGF-naïve cohort. Most T&E clinics were run as one-stop services (same-day monitoring and injection), whereas 4/10 PRN clinics were run as two-stop services (monitoring and injection on different days). In general, one-stop clinics used less staff resources and were likely to be shorter in duration for healthcare providers than the cumulative time spent for two-stop clinics. CONCLUSION: This is the first real-world observational study conducted in England and Wales demonstrating the effectiveness of the ranibizumab T&E regimen in anti-VEGF-naïve patients. T&E is compatible with one-stop clinic services, which these real-world data suggest to be less resource intensive than two-stop clinic services, possibly providing a dosing regimen beneficial to both patients and resource burden in UK clinical practice. FUNDING: Novartis Pharmaceuticals UK Limited.