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

Faricimab in neovascular AMD: first report of real-world outcomes in an independent retina clinic

Abstract Purpose: Assess short-term real-world outcomes in neovascular aged-related macular degeneration (nAMD) treated with novel faricimab. Methods: Retrospective case series of nine patients with nAMD (11 eyes) treated with faricimab between May and November 2022. Treatment-naïve patients and non-naïve patients underwent logMAR best corrected visual acuity (BCVA), optical coherence tomography (OCT) DRI OCT-1 Triton (Topcon Corp, Tokyo, Japan), ultra-widefield (UWF) and fundus autofluorescence (FAF) (California Optomap, Optos plc, Dunfermline, Scotland, UK). Previous treatment intervals, number of intravitreal injections, sub/intra retinal fluid (SRF/IRF), central retinal thickness (CRT) and presence/changes in pigment epithelial detachments (PEDs) were recorded. Results: Mean baseline BCVA and CRT values of patients who switched from other agents were 0.612 ± 0.75 logMAR and 256.16 ± 12.98 µm respectively, with a mean 36-day previous treatment interval. The median number of other previous anti-VEGF intravitreal injections was 8. Mean BCVA at one month significantly improved to 0.387 ± 0.54 logMAR, as well as CRT values which decreased to 245.43 ± 15.34 µm. In the 3 naïve patients, mean baseline BVCA and CRT values were 0.33 ± 0.29 and 874.67 ± 510.86 µm, respectively. At one month follow-up, mean BCVA improved to 0.30 ± 0.29 logMAR and mean CRT was 536.04 ± 36.15 µm. Overall, a significant improvement in BCVA of 0.21 ± 41 logMAR and 238.44 ± 114.9 µm was achieved at one month after the first faricimab intravitreal injection. In addition, a complete resolution of SRF was observed in 6 out of 8 eyes (75%) and of IRF in 2 out of 3 eyes (66.67%), respectively. Drusenoid PED morphology changes were observed in all patients and no drug-related adverse events were observed. Conclusion: Real-world outcomes showed improvement in BCVA and anatomic parameters at an early timepoint, demonstrating the efficacy and durability of faricimab in nAMD patients. Larger numbers of patients and longer follow-up are needed to determine whether the loading dose is required in all, what percentage of patients experience an improvement, and whether improvement it is maintained

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_&d=BQMFaQ&c=bMxC-A1upgdsx4J2OmDkk2Eep4PyO1BA6pjHrrW-ii0&r=7eyJJ8AWeg0LAg2jsrUotjxJxMXx-Ph-SVfpXeotLmg&m=gd8KSZ2q-0EknjXm4AycD2Fus7vBLej2uxBB1IdPpXo&s=WwGP-DH6EXzK_4VV6UBiNh0OQf6B571LE559LnerqVQ&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

Performance analysis of a new hypersonic vitrector system

<div><p>Purpose</p><p>To evaluate porcine vitreous flow and water flow rates in a new prototype hypersonic vitrectomy system compared to currently available pneumatic guillotine vitrectors (GVs) systems.</p><p>Methods</p><p>Two vitrectors were tested, a prototype, ultrasound-powered, hypersonic vitrector (HV) and a GV. Porcine vitreous was obtained within 12 to 24 h of sacrifice and kept at 4°C. A vial of vitreous or water was placed on a precision balance and its weight measured before and after the use of each vitrector. Test parameters included changes in aspiration levels, vitrector gauge, cut rates for GVs, % ultrasound (US) power for HVs, and port size for HVs. Data was analysed using linear regression and <i>t-</i>tests.</p><p>Results</p><p>There was no difference in the total average mean water flow between the 25-gauge GV and the 25-gauge HV (<i>t</i>-test: <i>P</i> = 0.363); however, 25-gauge GV was superior (<i>t</i>-test: <i>P</i> < 0.001) in vitreous flow. The 23-gauge GV was only more efficient in water and vitreous removal than 23-gauge HV needle-1 (Port 0.0055) (<i>t</i>-test: <i>P</i> < 0.001). For HV, wall thickness and gauge had no effect on flow rates. Water and vitreous flows showed a direct correlation with increasing aspiration levels and % US power (p<0.05).</p><p>Conclusions</p><p>The HV produced consistent water and vitreous flow rates across the range of US power and aspiration levels tested. Hypersonic vitrectomy may be a promising new alternative to the currently available guillotine-based technologies.</p></div

Navigated single-capture 3D and cross-sectional wide-field OCT of the mid and peripheral retina and vitreoretinal interface

Purpose: Assess the mid and peripheral neuroretina and vitreoretinal interface using a novel Navigated Single-Capture 3D and Cross-Sectional Wide-Field Swept-Source Optical Coherence Tomography (WF SS-OCT) technology with correlation to Multi-Wavelength Ultra-Widefield Imaging (MW UWFI) and Histopathology reference. Methods: Retrospective observational study. A total of 74 patients (148 eyes) were imaged using WF SS-OCT and Navigated Single-Capture twelve 23 mm cross-sectional radial scan pattern at 15° intervals. Image diagnosis included: congenital hypertrophy of the retinal pigment epithelium, choroidal nevus, ora serrata pearls, retinal tuft, lattice, snail track, cobblestone degeneration, retinal hole, retinal tear, degenerative retinoschisis, peripheral laser retinopexy, white without pressure, vitreous floaters, subclinical peripheral rhegmatogenous retinal detachment (RD), and tractional RD in proliferative diabetic retinopathy. WF SS-OCT images were correlated with MW UWFI and histopathological references where available. Results: WF SS-OCT successfully imaged structural features in all diagnoses with significant improvement in diagnostic capability and increased the diagnosis of specific features such as vitreoretinal attachment, full thickness hole or tear and subretinal fluid. Histopathological correlation was available for five (5) different peripheral retinal pathologies imaged by both WF SS-OCT and MW UWFI and good anatomical correlation was observed in all diagnosis. Conclusions: Navigated Single-Capture 3D and Cross-Sectional WF SS-OCT provides detailed anatomic information of the mid and peripheral neuroretina and vitreoretinal interface, allowing early recognition of vision-threatening features that may influence clinical management, particularly in an era of telemedicine or when there is limited or no access to Indirect Ophthalmoscopy with 360° Scleral Indentation

Increase in vitreous flow rate by increments of power or vacuum.

<p>Increase in vitreous flow rate by increments of power or vacuum.</p

Live porcine thirty days delayed recovery surgery: Qualitative findings with the hypersonic vitrectomy

INTRODUCTION:Qualitatively assess the possible delayed structural, macroscopic and microscopic changes in the neuro-retina, retinal vasculature, retinal pigment epithelium (RPE) and optic nerve head (ONH) after pars plana vitrectomy (PPV) surgery using a new hypersonic vitrector (HV). MATERIALS AND METHODS:Eight live porcine eyes underwent PPV using either the HV or a conventional pneumatic guillotine vitrector (GV). The un-operated fellow eye from each pig was used as an external control. The pigs were post-operatively kept alive for 30 days before termination and enucleation of the eyes. Prior to enucleation, all eyes underwent examination of the lens and indirect ophthalmoscopy. Enucleated eyes were fixed in formalin, examined macroscopically and processed for histological assessment. Microscopic analysis included assessment of neuro-retina, retinal vasculature, RPE and ONH, as well as observation for any morphological intraocular changes. Comparison was made between: (1) treated and untreated areas of the same eye (internal control) (2) different areas within the same eye operated on using different vitrector settings (3) eyes operated on with the HV and GV (4) eyes receiving surgery and the fellow un-operated eye (external control, same pig). RESULTS:All lenses had remained clear at 30 days into the postoperative period. On indirect ophthalmoscopy, the retina had remained attached in all eyes with no visible changes to the neuro-retina, retinal vasculature, RPE or ONH. Two eyes showed localized RPE depigmentation secondary to previously documented intraoperative retinal touch. The Morphological changes in the retinal layers above depigmented RPE were no different from retinal change elsewhere. There were mild and similar microscopic changes observed in the neuro-retina, retinal vasculature, RPE or ONH associated with either the HV or GV PPVs. Preliminary histological findings revealed no significant differences between eyes operated on with the HV and those operated on the GV. DISCUSSION:At 30 days into the postoperative period, there seemed to be similar morphological changes attributable to the use of HV and GV. Therefore, the HV promises to be a new alternative to the currently commercially available GV for PPV

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

Performance analysis of a new hypersonic vitrector system - Fig 2

<p><b>(A)</b> Predicted and actual water flow through HV cutter for Vacuum * port area cross term. (<b>B)</b> Predicted and actual water flow through HV device for √Vacuum * port area cross term.</p