From the editors of Review of Ophthalmology:
OCTOBER IS HALLOWEEN SAFETY MONTH
In this issue: (click heading to view article)
Incomplete RPE & Outer Retinal Atrophy (iRORA) in AMD: CAM Report 4
Researchers described the defining features of “incomplete retinal pigment epithelial and outer retinal atrophy” (iRORA), a consensus term referring to optical coherence tomography-based anatomical changes often identified prior to the development of “complete RPE and outer retinal atrophy (cRORA)” in age-related macular degeneration. They provided descriptive OCT and histological examples of disease progression, as part of a consensus meeting.
Participants included a panel of retina specialists, including retinal imaging experts, reading-center leaders and retinal histologists. As part of the Classification of Atrophy Meeting (CAM) program, an international group of experts analyzed and discussed longitudinal multimodal imaging of AMD eyes. They reached consensus on a classification system for OCT-based structural alterations occurring prior to the development of atrophy secondary to AMD. And they defined terms of complete and incomplete RPE and outer retinal atrophy (iRORA and cRORA).
Main outcome measures included defining the term iRORA through OCT imaging and longitudinal cases showing progression of atrophy, with histologic correlates. OCT was used in cases of early and intermediate AMD as the base imaging modality to identify cases of iRORA.
In the context of drusen, iRORA was defined on OCT as: (1) a region of signal hypertransmission into the choroid; (2) a corresponding zone of attenuation or disruption of the RPE; and (3) evidence of overlying photoreceptor degeneration. The group clarified that the term iRORA shouldn’t be used when RPE tears are present. Longitudinal studies confirmed the concept of progression from iRORA to cRORA.
The group provided international consensus classification for OCT-defined anatomical features of iRORA, and provided examples of longitudinal progression to cRORA. They concluded that the ability to identify such OCT changes reproducibly was essential to better understanding the natural history of disease, identifying high-risk signs of progression and studying early interventions. They added that longitudinal data would be required to quantify the implied risk of vision loss associated with the terms and that the CAM classification provided initial definitions to enable such future initiatives, with the understanding that the classification would be refined as new data are generated.
SOURCE: Guymer RH, Rosenfeld PJ, Curcio CA, et al. Incomplete retinal pigment epithelial and outer retinal atrophy (iRORA) in age-related macular degeneration: CAM Report 4. Ophthalmology 2019; Sep 30. [Epub ahead of print].
Structure-function Relationship in Advanced Glaucoma After Reaching the RNFL Floor
Investigators evaluated the relationship between the central visual field (VF) and macular parameters obtained from spectral-domain optical coherence tomography in individuals with advanced glaucoma that reached the circumpapillary retinal nerve fiber layer (cpRNFL) thickness measurement floor. In addition, they determined whether the structural changes measured by SD-OCT were useful for estimating the functional status in relevant individuals.
A total of 68 eyes from 68 individuals with advanced glaucoma were included. Only eyes having an average cpRNFL thickness of 57 μm or less that reached the measurement floor were included. Investigators performed macular imaging using Cirrus SD-OCT and 10-2 Humphrey VF. They converted VF mean deviation (MD) to a linear scale using unlogged 1/Lambert values. And they determined relationships between the central VF and various macular parameters. Here were some of the findings:
• Patients had a mean VF MD of -20.69 dB and an average cpRNFL thickness of 51.76 ±3.61 μm.
• Correlations between the VF and all cpRNFL thickness parameters weren’t significant.
• Significant correlations were found between the central VF and superonasal macular ganglion cell-inner plexiform layer thickness (r=0.334, p=0.003), inner nasal macular thickness (r=0.301, p=0.013) and outer nasal macular thickness (r=0.331, p=0.007).
Investigators found that even after the cpRNFL had reached the measurement floor, several macular parameters showed a statistically significant relationship with functional status in VF. In particular, they wrote, the assessment of structural changes in the nasal macular region may be important in determining the central VF in advanced glaucoma.
SOURCE: Sung MS, Heo H, Park SW, et al. Structure-function relationship in advanced glaucoma after reaching the RNFL Floor. J Glaucoma 2019; Sep 25. [Epub ahead of print].
Outcomes of Repeat Anterior Lamellar Keratoplasty
Scientists described the outcomes and complications of repeat anterior lamellar keratoplasty after a failed primary ALK, as part of a retrospective case series.
Twenty-three eyes of 22 patients who underwent repeat ALK for optical indications from Jan. 1, 1991, to Dec. 31, 2017, were included. Clinical data were recorded from the Singapore Corneal Transplant Study database. Outcome measures were graft survival, best-corrected visual acuity and complications.
Of the 780 cases of ALK performed for optical indications during the study period, 23 cases (2.9 percent) underwent repeat ALK. Primary ALK included 16 deep ALK and seven automated lamellar therapeutic keratoplasty cases. Here were some of the findings:
• After repeat ALK, 21 eyes had further dissection down to the descemetic or pre-descemetic plane, whereas two eyes had graft exchange for failed automated lamellar therapeutic keratoplasty.
• The graft survival of repeat ALK was 93.2 percent at one year, 86.1 percent at three years and 78.3 percent at five years.
• Four cases of graft failure with a mean time to failure of 2 ±1.7 years were found.
• After the repeat ALK procedure, 63.6 percent of eyes achieved a BCVA of logMAR +0.3 (20/40) or better at one year, and 66.7 percent achieved a BCVA of logMAR +0.3 (20/40) or better at two years.
• Five eyes (17.4 percent) had an intraoperative microperforation.
Scientists found that, in the case of a failed ALK graft for a range of optical indications, a repeat ALK procedure offered a viable and safe surgical option with good long-term graft survival and visual outcomes. They added that this option also avoided various disadvantages of performing penetrating keratoplasty, especially the risk of allograft endothelial rejection.
SOURCE: Woo JH, Tan YL, Htoon HM, et al. Outcomes of repeat anterior lamellar keratoplasty. Cornea 2019; Oct 3. [Epub ahead of print].
Projection-resolved OCTA-Based Metrics for Early Detection of Retinal Microvascular Impairments in Diabetes Mellitus
Researchers assessed the ability of nonperfusion, vessel density and morphologic measurements using projection-resolved optical coherence tomography angiography to detect early retinal microvasculature impairments in diabetes mellitus.
They performed a retrospective review on type 2 DM patients with no diabetic retinopathy, or mild nonproliferative DR and age-matched controls imaged with optical coherence tomography angiography. In addition, researchers measured foveal avascular zone-related metrics and extrafoveal avascular area in OCTA images. And they calculated vessel density and fractal dimension with and without a skeletonization process, and computed the vessel diameter index and vessel tortuosity. The area under the receiver operating characteristic curve estimated diagnostic performances. Here were some of the findings:
• Dilated capillary diameter was observed in the deep capillary plexus in the diabetic groups.
• The vessel density and fractal dimension of the skeletonized deep capillary plexus significantly and progressively decreased in the no DR and mild nonproliferative DR groups compared with controls.
• The AUCs of the superficial extrafoveal avascular area (0.885), vessel density (0.876) and fractal dimension of the skeletonized deep capillary plexus (0.876) had the highest diagnostic performance to differentiate mild nonproliferative DR from control eyes.
Researchers wrote that vessel density and fractal dimension from the skeletonized deep capillary network may be the most sensitive for detecting early retinal capillary loss in diabetes mellitus.
Source: Zhu TP, Li EH, Li JY, et al. Comparison of projection-resolved optical coherence tomography angiography-based metrics for the early detection of retinal microvascular impairments in diabetes mellitus. Retina 2019; Oct 1. [Epub ahead of print.]
New Wet AMD Treatment Approved: Novartis’ Brolucizumab
FDA just approved Novartis’ Beovu (brolucizumab-dbll) for the treatment of wet age-related macular degeneration. Novartis says Beovu is the first anti-VEGF recommended to start eligible patients on up to three-month dosing intervals immediately following a three-month loading phase. Beovu’s approval is based on results from the Phase III HAWK and HARRIER studies, which compared the efficacy and safety of Beovu with aflibercept (Eylea, Regeneron). Beovu met the primary endpoint of these trials, which was non-inferiority in average change in best-corrected visual acuity from baseline to week 48. In addition to the possibility of longer treatment intervals for eligible patients, Beovu demonstrated greater reductions in central subfield thickness—an indicator of fluid in the retina—when compared to aflibercept, Novartis says.
Genentech/Roche Presents Phase II Ladder Trial Data, Completes Patient Enrollment in Phase III YOSEMITE & RHINE Trials
At the American Academy of Ophthalmology annual meeting and Retina Subspecialty Day (Oct. 11 to 15) in San Francisco, Genentech/Roche was expected to present data on the Ladder Phase II Trial of the Investigational Port Delivery System with ranibizumab in wet AMD. In the study, patients randomized to the 100 mg/mL PDS group had an average time to the first required implant refill of 15.8 months, and nearly half of patients in this group completed the study without needing a refill.
In addition, Genentech/Roche completed patient enrollment ahead of schedule for the Phase III YOSEMITE and RHINE clinical trials investigating faricimab in diabetic macular edema. Faricimab is a bispecific antibody designed specifically for the treatment of retinal eye diseases. The investigational medicine simultaneously binds to and neutralizes angiopoietin-2 and vascular endothelial growth factor A, and may lead to improved and sustained efficacy at longer treatment intervals the companies say.
AAO & Verana Health Offer Genetic Testing
The American Academy of Ophthalmology and Verana Health are offering no-cost genetic testing and counseling for patients with certain inherited retinal diseases through Verana Trial Connect, a cloud-based application that the organizations say broadens physician and patient awareness of clinical trial opportunities. Using information from the AAO’s Intelligent Research in Sight Registry, Verana Trial Connect aims to accelerate trial enrollment. Physicians can learn more at AAO 2019 by visiting Verana booth #2047, or attending various courses and presentations at the AAO. Learn more.
Ocular Therapeutix Announces Permanent J-Code for Dextenza
Ocular Therapeutix announced the Centers for Medicare and Medicaid Services issued a permanent product-specific J-code for Dextenza (dexamethasone ophthalmic insert) 0.4 mg for intracanalicular use. Under the Healthcare Common Procedure Coding System, the J-code (J1096) became effective Oct. 1, and replaces the previously issued C-code for Dextenza (C9048). Read more.
B+L Announces New Scientific & Clinical Analyses to be Presented During AAO Meeting
Bausch + Lomb announced that eight new scientific poster and clinical presentations involving the company’s products, and data from the company’s Antibiotic Resistance Monitoring in Ocular MicRoorganisms (ARMOR) surveillance study, will be presented during AAO 2019. In addition, the company says that surgeons can gain hands-on experience with various products from the company’s surgical portfolio, including the full family of enVista IOLs and Storz Instruments, at exhibit booth #6266, along with at sponsor educational events and the company-sponsored Run for Vision. See the complete list of events.
J&J Vision Launches Worldwide #ConnectedBySight Campaign
In honor of World Sight Day on Oct. 10, Johnson & Johnson Vision launched a worldwide campaign to share the untold stories of eye-care professionals, patients and organizations who are inspiring the elevation of eye health as a global priority. On Oct. 7, the company launched Worldwide #ConnectedBySight Campaign. Through its ongoing support of Lions Clubs International Foundation's Sight for Kids and Himalayan Cataract Project, Johnson & Johnson Vision has committed to provide 100,000 children with access to vision screenings and 1,000 sight-restoring surgeries to cataract patients. Read more.
ImprimisRx to Focus on Investments in Quality
At AAO 2019. ImprimisRx will discuss its ongoing investments in cGMP (Current Good Manufacturing Practices)—the highest federal drug manufacturing standards. As an FDA-registered and FDA-inspected outsourcing facility, ImprimisRx says that it continues to make significant investments in equipment, processes and personnel to comply with these standards. Read more.
CATS Tonometer Prism Now Available
The CATS Tonometer Reusable Prism is now available for order through a variety of key distributors in the United States, the company says. CATS says that the FDA-cleared tonometer prism was created to set a new standard in reliable Goldmann IOP measurement. The patented applanation surface of the prism is designed to integrate into a clinician’s practice at no additional cost and requiring no new training, with the goal of streamlining patient care. It will be introduced at AAO 2019. Learn more.
Allegro to Present Clinical Research on Integrin-regulating Portfolio
Allegro Ophthalmics announced that the results of its U.S. Phase II clinical study of risuteganib (Luminate) for the treatment of intermediate non-exudative age-related macular degeneration would be presented during AAO 2019. Learn more.
Optovue Introduces NetVue Cloud Image Management Solutions
Optovue recently imtroduced NetVue Cloud image management software. The company says that NetVue provides rapid access to patients' images and data on a single screen, eliminating the need to open device-specific applications. There is no gateway application required so images can be viewed anytime and from any device directly from a web browser. AAO attendees can see the solution at booth #1914. Read more.
MST Acquires Trabectome and Goniotome
This week, MicroSurgical Technology acquired the assets of NeoMedix Corp. related to glaucoma, including Trabectome and Goniotome product platforms.
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