The cost-effectiveness of the Argus II retinal prosthesis in Retinitis Pigmentosa patients

Background: Retinitis Pigmentosa (RP) is a hereditary genetic disease causing bilateral retinal degeneration. RP is a leading cause of blindness resulting in incurable visual impairment and drastic reduction in the Quality of life of the patients. Second Sight Medical Products Inc. developed Argus II, a retinal prosthesis system for treating RP. Argus II is the world’s first ever-commercial implant intended to restore some vision in the blind patients. The objective of this study was to assess the cost-effectiveness of the Argus® II Retinal Prosthesis System (Argus II) in Retinitis Pigmentosa (RP) patients. Method: A multi -state transition Markov model was developed to determine the cost-effectiveness of Argus II versus usual care in RP from the perspective of healthcare payer. A hypothetical cohort of 1000 RP patients aged 46 years followed up over a (lifetime) 25-year time horizon. Health outcomes were expressed as quality adjusted life years (QALYs) and direct healthcare costs expressed in 2012 €. Results are reported as incremental cost per ratios (ICERs) with outcomes and costs discounted at an annual rate of 3.5%. Results: The ICER for Argus II was €14,603/QALY. Taking into account the uncertainty in model inputs the ICER was €14,482/QALY in the probabilistic analysis. In the scenarios of an assumption of no reduction on cost across model visual acuity states or a model time horizon as short as 10 years the ICER increased to €31,890/QALY and €49,769/QALY respectively. Conclusion: This economic evaluation shows that Argus II is a cost-effective intervention compared to usual care of the RP patients. The lifetime analysis ICER for Argus II falls below the published societal willingness to pay of EuroZone countries

Long-Term Results from an Epiretinal Prosthesis to Restore Sight to the Blind

PurposeRetinitis pigmentosa (RP) is a group of inherited retinal degenerations leading to blindness due to photoreceptor loss. Retinitis pigmentosa is a rare disease, affecting only approximately 100 000 people in the United States. There is no cure and no approved medical therapy to slow or reverse RP. The purpose of this clinical trial was to evaluate the safety, reliability, and benefit of the Argus II Retinal Prosthesis System (Second Sight Medical Products, Inc, Sylmar, CA) in restoring some visual function to subjects completely blind from RP. We report clinical trial results at 1 and 3 years after implantation.DesignThe study is a multicenter, single-arm, prospective clinical trial.ParticipantsThere were 30 subjects in 10 centers in the United States and Europe. Subjects served as their own controls, that is, implanted eye versus fellow eye, and system on versus system off (native residual vision).MethodsThe Argus II System was implanted on and in a single eye (typically the worse-seeing eye) of blind subjects. Subjects wore glasses mounted with a small camera and a video processor that converted images into stimulation patterns sent to the electrode array on the retina.Main Outcome MeasuresThe primary outcome measures were safety (the number, seriousness, and relatedness of adverse events) and visual function, as measured by 3 computer-based, objective tests.ResultsA total of 29 of 30 subjects had functioning Argus II Systems implants 3 years after implantation. Eleven subjects experienced a total of 23 serious device- or surgery-related adverse events. All were treated with standard ophthalmic care. As a group, subjects performed significantly better with the system on than off on all visual function tests and functional vision assessments.ConclusionsThe 3-year results of the Argus II trial support the long-term safety profile and benefit of the Argus II System for patients blind from RP. Earlier results from this trial were used to gain approval of the Argus II by the Food and Drug Administration and a CE mark in Europe. The Argus II System is the first and only retinal implant to have both approvals

Health, education, and social care provision after diagnosis of childhood visual disability

Aim: To investigate the health, education, and social care provision for children newly diagnosed with visual disability.Method: This was a national prospective study, the British Childhood Visual Impairment and Blindness Study 2 (BCVIS2), ascertaining new diagnoses of visual impairment or severe visual impairment and blindness (SVIBL), or equivalent vi-sion. Data collection was performed by managing clinicians up to 1-year follow-up, and included health and developmental needs, and health, education, and social care provision.Results: BCVIS2 identified 784 children newly diagnosed with visual impairment/SVIBL (313 with visual impairment, 471 with SVIBL). Most children had associated systemic disorders (559 [71%], 167 [54%] with visual impairment, and 392 [84%] with SVIBL). Care from multidisciplinary teams was provided for 549 children (70%). Two-thirds (515) had not received an Education, Health, and Care Plan (EHCP). Fewer children with visual impairment had seen a specialist teacher (SVIBL 35%, visual impairment 28%, χ2p < 0.001), or had an EHCP (11% vs 7%, χ2p < 0 . 01).Interpretation: Families need additional support from managing clinicians to access recommended complex interventions such as the use of multidisciplinary teams and educational support. This need is pressing, as the population of children with visual impairment/SVIBL is expected to grow in size and complexity.This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited

Implanting the Argus(R) II Retinal Prosthesis System in a patient with dry AMD

The following is an edited movie of a previously live-streamed surgical video featuring renowned Consultant Ophthalmologist and Vitreoretinal surgeon Professor Paulo E. Stanga, MD, implanting the Argus® II Retinal Prosthesis System in a patient with dry Age Related Macular Degeneration (AMD). To date, June 2016, over 180 Argus® II devices have been implanted worldwide, and are used routinely in advanced Retinitis Pigmentosa patients. This video, recorded at Manchester Royal Eye Hospital, UK, in April 2016, shows Prof. Stanga performing the procedure on a dry AMD patient as part of an investigational study of the Argus® II system in dry AMD (clinicaltrials.gov #NCT02227498 (https://urldefense.proofpoint.com/v2/url?u=http-3A__clinicaltrials.gov_&amp;d=BQMFaQ&amp;c=bMxC-A1upgdsx4J2OmDkk2Eep4PyO1BA6pjHrrW-ii0&amp;r=7eyJJ8AWeg0LAg2jsrUotjxJxMXx-Ph-SVfpXeotLmg&amp;m=gd8KSZ2q-0EknjXm4AycD2Fus7vBLej2uxBB1IdPpXo&amp;s=WwGP-DH6EXzK_4VV6UBiNh0OQf6B571LE559LnerqVQ&amp;e=), being conducted under an approval from MHRA and the Ethics Committee at Manchester Royal Eye Hospital). The trial patients are the first in history to combine artificial vision provided by the Argus® II with their remaining natural peripheral sight. The surgery is commentated by Dr. Suber Huang, of University Hospitals Case Medical Center, Cleveland, Ohio and Francesco Merlini of Second Sight Medical Products Inc

The effect of bevacizumab before vitrectomy for diabetic tractional retinal detachment demonstrated on optical coherence tomography angiography

Purpose: To demonstrate the effect of intravitreal bevacizumab (IVB) on the size and vascularity of the fibro-vascular complex with the optical coherence tomography angiography (OCTA) before pars plana vitrectomy (PPV). Methods: Observational case series of three eyes with active diabetic fibro-vascular complex and tractional retinal detachment (TRD) who underwent IVB (1.25 mg/0.05 ml) two days before proceeding to PPV. OCTA was carried out prior to IVB, two days after IVB and six weeks after PPV. Results: OCTA showed a reduction in the size and calibre of the diabetic fibro-vascular complex two days after IVB in all the cases. Consequently, there was less traumatic dissection of the fibro-vascular membranes during PPV and thus reduced chances of intraoperative and postoperative vitreous cavity bleeding. One case showed mild hemorrhage in the posterior vitreous on the second day post-injection which implies the increased traction caused by IVB. Conclusions: In this case series, we have used OCTA to demonstrate how IVB is highly effective in reducing the vascularity of diabetic fibro-vascular membranes. This finding also suggests that the use of IVB before PPV in the management of diabetic TRD could also be much shorter than the advocated standard practice of one week in most institutions. Keywords: Bevacizumab, Diabetic tractional retinal detachment, OCTA, Vitreous hemorrhag

X‐linked retinoschisis: an update

X‐linked retinoschisis is the leading cause of macular degeneration in males and leads to splitting within the inner retinal layers leading to visual deterioration. Many missense and protein truncating mutations have now been identified in the causative retinoschisis gene (RS1) which encodes a 224 amino acid secreting retinal protein, retinoschisin. Retinoschisin octamerises is implicated in cell–cell interactions and cell adhesion perhaps by interacting with β2 laminin. Mutations cause loss of retinoschisin function by one of the three mechanisms: by interfering with protein secretion, by preventing its octamerisation or by reducing function in the secreted octamerised protein. The development of retinoschisis mouse models have provided a model system that closely resembles the human disease. Recent reports of RS1 gene transfer to these models and the sustained restoration of some retinal function and morphology suggest gene replacement may be a possible future therapy for patients