Plasma Concentration as a Proxy for Perilymph Drug Levels: Preclinical and Clinical Dexamethasone Measures with a Long-Acting Formulation for Precise Delivery to the Round Window Membrane.

Objective: To use animal pharmacokinetic data and FluidSIM modeling to estimate human dexamethasone perilymph concentrations from plasma concentration measurements over time following a single intratympanic administration of SPT-2101.

Study Design: Perilymph and plasma dexamethasone concentrations were measured in guinea pigs and African green monkeys over 3 to 6 weeks post-intratympanic administration of SPT-2101. Plasma concentrations of dexamethasone were measured in Ménière's disease patients post-intratympanic administration of SPT-2101.

Early Experience with a Novel Treatment for Menière's Disease: A Long Acting Dexamethasone Formulation for Precise Delivery to the Round Window Membrane.

Objective: To investigate the safety and feasibility of precise delivery of a long-acting gel formulation containing 6% dexamethasone (SPT-2101) to the round window membrane for the treatment of Menière's disease.

Study Design: Prospective, unblinded, cohort study.

Setting: Tertiary care neurotology clinic.

Macular vessel density in central retinal artery occlusion with retinal arterial cannulation.

To characterize and compare macular vessel density in central retinal artery occlusion (CRAO) eyes with retinal arterial cannulation and CRAO eyes with standard treatment. This study was Cross-sectional, observational study. Twenty-two eyes with nonarteric CRAO which underwent retinal arterial cannulation and 19 eyes with nonarteric CRAO with standard treatment were included.

Development of the Port Delivery System with ranibizumab for neovascular age-related macular degeneration.

Purpose Of Review: This review provides background on the remaining unmet needs with antivascular endothelial growth factor (VEGF) therapies for the treatment of neovascular age-related macular degeneration (nAMD). We also discuss the developmental story of the Port Delivery System with ranibizumab (PDS; SUSVIMO, Genentech, Inc., South San Francisco, CA, USA).

Endovascular surgery in the field of ophthalmology.

In this article, we provide an overview of the current perspectives on endovascular surgery in ophthalmology, including a description of the various approaches, recent clinical results and future prospects. Experimental studies of endovascular surgery in ophthalmology started in the 1980s; since then, a considerable amount of research has been done to develop the procedure for clinical use. During the past two decades endovascular surgery has been performed on eyes with retinal vascular disorders, including central retinal vein occlusion and central retinal artery occlusion.

ADVERSE EVENTS OF THE ARGUS II RETINAL PROSTHESIS: Incidence, Causes, and Best Practices for Managing and Preventing Conjunctival Erosion.

Purpose: To analyze and provide an overview of the incidence, management, and prevention of conjunctival erosion in Argus II clinical trial subjects and postapproval patients.

Methods: This retrospective analysis followed the results of 274 patients treated with the Argus II Retinal Prosthesis System between June 2007 and November 2017, including 30 subjects from the US and European clinical trials, and 244 patients in the postapproval phase. Results were gathered for incidence of a serious adverse event, incidence of conjunctival erosion, occurrence sites, rates of erosion, and erosion timing.

Novel positioning sensor with real-time feedback for improved postoperative positioning: pilot study in control subjects.

Introduction: Repair of retinal detachment frequently requires use of intraocular gas. Patients are instructed to position themselves postoperatively to appose the intraocular bubble to the retinal break(s). We developed a novel wearable wireless positioning sensor, which provides real-time audiovisual feedback on the accuracy of positioning.

The Bionic Eye: A Quarter Century of Retinal Prosthesis Research and Development.

This article describes the history of visual prostheses, with emphasis on the development of the Argus II retinal prosthesis system (Second Sight Medical Products, Inc., Sylmar, CA). A brief overview of cortical electrical stimulation in the blind is provided, followed by an account of the design and development of retinal stimulation equipment at the Duke Eye Center in the late 1980s; the first human intraoperative tests there and the subsequent 8 years of tests at the Wilmer Eye Institute; the transfer of the project to the Doheny Eye Institute at the University of Southern California and the founding of Second Sight Medical Products; and the development and clinical trials of the Argus I and Argus II systems.

Five-Year Safety and Performance Results from the Argus II Retinal Prosthesis System Clinical Trial.

Purpose: The Argus II Retinal Prosthesis System (Second Sight Medical Products, Inc, Sylmar, CA) was developed to restore some vision to patients blind as a result of retinitis pigmentosa (RP) or outer retinal degeneration. A clinical trial was initiated in 2006 to study the long-term safety and efficacy of the Argus II System in patients with bare or no light perception resulting from end-stage RP.

Design: Prospective, multicenter, single-arm clinical trial.

Worldwide Argus II implantation: recommendations to optimize patient outcomes.

Background: A position paper based on the collective experiences of Argus II Retinal Prosthesis System investigators to review strategies to optimize outcomes in patients with retinitis pigmentosa undergoing retinal prosthesis implantation.

Methods: Retinal surgeons, device programmers, and rehabilitation specialists from Europe, Canada, Middle East, and the United States were convened to the first international Argus II Investigator Meeting held in Ann Arbor, MI in March 2015. The recommendations from the collective experiences were collected.

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

Purpose: Retinitis 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.

Same-Day Versus Next-Day Repair of Fovea-Threatening Primary Rhegmatogenous Retinal Detachments.

Purpose: To evaluate the outcomes of same-day versus next-day repair of fovea-threatening rhegmatogenous retinal detachments (FT RRD).

Design: Retrospective, multi-surgeon observational case series.

Methods: Operative reports and medical records were reviewed to evaluate a number of visual and anatomic outcomes, including presenting features, intraoperative complications, and postoperative results in the repair of primary FT RRD undergoing same-day versus next-day repair with scleral buckling, pars plana vitrectomy, or both procedures.

Extraction of retinal tacks from subjects implanted with an epiretinal visual prosthesis.

Background: Retinal tacks, first developed for the treatment of complex retinal detachments, have more recently been used for the fixation of epiretinal electrode arrays as part of implanted visual prostheses. Here, we report on the clinical experience of extracting four such tacks after chronic implantation. The ability to safely extract retinal tacks ensures that epiretinal devices can be repositioned or removed if necessary.

Effect of intravitreal bevacizumab on intraocular pressure in a case of severe chronic hypotony.

Purpose: Chronic severe hypotony is associated with many serious ocular consequences, including phthisis. This case illustrates a possible new therapy for chronic hypotony.

Methods: This study is a case report of a 75-year-old man who had undergone trabeculectomy followed by multiple retinal surgeries and developed chronic hypotony in the left eye for more than 1 year.

Subretinal delivery of immunoglobulin G with gold nanoparticles in the rabbit eye.

Purpose: To examine the feasibility of subretinal delivery of immunoglobulin G (IgG) adsorbed onto gold nanoparticles (GNPs) and its histologic distribution in the rabbit retina after the injection.

Methods: Goat IgG was adsorbed onto GNPs electrostatically. Goat IgG-adsorbed GNPs or buffer with goat IgG was injected into the subretinal space of rabbit eyes and followed up for 3 months by examination of fundus photographs, immunohistochemistry against goat IgG, and transmission electron microscopy (TEM).

Effect of oxygenated intraocular irrigation solutions on the electroretinogram after vitrectomy.

Purpose: To investigate the effect of oxygenated intraocular irrigating solutions on electroretinograms (ERGs) for postvitrectomy rabbits.

Methods: Eight groups of five rabbits each underwent pars plana vitrectomy on the right eye; the left eye of each rabbit served as control. The intraocular irrigating solutions were balanced salt solution (BSS), BSS-plus, BSS + oxygen (BSS + O2), BSS-plus + O2, and combinations of each with the addition of endoillumination (L).

A novel method to oxygenate intraocular irrigation fluids with an in-line oxygenator.

Purpose: We describe a novel method to oxygenate intraocular irrigation solutions involving an in-line oxygenator.

Methods: Either lactated Ringer (LR) solution or balanced salt solution (BSS) was oxygenated with the FE390 Stainless In-line Oxygenation Assembly (Beer, Beer, and More Beer, Concord, CA). After running a 100-mL of solution through the in-line oxygenator, oxygen saturation was measured with a dissolved oxygen meter.

Application of a new subretinal injection device in the dog.

The use of a new subretinal injection device (RetinaJect Subretinal Cannula, SurModics, Inc., Eden Prairie, MN) to access the subretinal space in the canine model was evaluated. Subretinal injections were performed in 33 mongrel dogs between 2 and 52 months of age (median = 9 months).

A new model of experimental subretinal neovascularization in the rabbit.

Existing animal models of choroidal neovascularization (CNV) present several problems: they are hard to reproduce, they are inefficient, and the CNV created is not sustainable. The purpose of this study is to develop a highly efficient, reliable, sustainable rabbit model of CNV to facilitate the study of anti-angiogenic and anti-proliferative therapies for ocular diseases. Twenty-two pigmented rabbits were used in this study.

One-year results of a pilot study using oral 13-cis retinoic acid as a treatment for subfoveal predominantly occult choroidal neovascularization in patients with age-related macular degeneration.

Purpose: To evaluate the safety and evidence of efficacy for oral 13-cis retinoic acid as a treatment for patients with subfoveal occult choroidal neovascularization (CNV) due to age-related macular degeneration (ARMD).

Methods: Patients with active, subfoveal occult CNV with no prior treatment of the subfoveal component were eligible for inclusion. Patients received 40 mg of 13-cis retinoic acid twice daily for 5 months, stopped treatment for 2 months, and then resumed treatment for 5 months.

Development, implantation, in vivo elution, and retrieval of a biocompatible, sustained release subretinal drug delivery system.

A biocompatible, sustained-release subretinal drug-delivery platform was developed to overcome the therapeutic accessibility limitations of current retinal disease treatments. The prototype implants were fabricated by coating nitinol, poly(methyl methacrylate) or chromic gut core filaments, with a drug-eluting polymer matrix. The polymer coatings are manufactured and coated by SurModics.

Rapid recurrence of geographic atrophy after full macular translocation for nonexudative age-related macular degeneration.

Objective: To report the recurrence of geographic atrophy (GA) in a patient with nonexudative age-related macular degeneration (AMD) after full macular translocation.

Design: Observational case report.

Methods: Review of the clinical, photographic, and angiographic records of a patient with GA who underwent full macular translocation.

Fabrication, implantation, elution, and retrieval of a steroid-loaded polycaprolactone subretinal implant.

A subretinal drug delivery system was developed to overcome the limitations of current treatments for retinal disease. A rod-shaped implant was made by embedding the corticosteroid triamcinolone acetonide within a biodegradable polycaprolactone polymer matrix. The implant was fabricated by homogeneously mixing the polymer and drug in solvent.