From the editors of Review of Ophthalmology:
OCTOBER IS HALLOWEEN SAFETY MONTH
In this issue: (click heading to view article)
Ranibizumab vs. Aflibercept for nAMD: Data from Fight Retinal Blindness! Registry
Researchers compared the three-year treatment outcomes of ranibizumab and aflibercept for the treatment of neovascular age-related macular degeneration in routine clinical practice. The retrospective analysis used data from the prospectively designed observational outcomes registry known as Fight Retinal Blindness! project.
Included were treatment-naïve eyes starting nAMD treatment from December 2013 to December 2015 with either ranibizumab or aflibercept that were tracked in the registry. Researchers analyzed visual acuity annually in completers (eyes of participants who completed three years of treatment) and in all eyes (completers, non-completers and eyes that switched treatment).
The primary outcome was a mean change in VA (number of letters read on a logMAR chart). A total of 965 eyes of 897 patients (ranibizumab: 499 eyes of 469 patients; aflibercept: 466 eyes of 432 patients) were identified. Here were some of the findings:
• The mean VA and the type of the choroidal neovascular lesion at the start of treatment was similar between the two groups.
• The group receiving ranibizumab was older.
• The crude mean VA change of +1.5 letters (CI, 0 to 3.1) in the ranibizumab group and +1.6 letters (CI, -0.2 to 3.3; p=
0.97) in the aflibercept group at three years in all eyes was similar, as was the adjusted mean VA change: +0.3 (CI, -1.5 to 2) vs. +1 (CI, -0.7 to 2.8; p=
• Eyes of participants who completed three years of treatment in each of the groups received a median (Q1, Q3) of 18 (16, 22) injections for ranibizumab vs. 18 (15, 21; p=
0.1) for aflibercept from a median of 21 (17, 25) vs. 21 (17, 26; p=
0.25) clinical visits.
• The adjusted proportion of clinical visits during which the CNV was graded as active over three years was similar between ranibizumab (43 percent) and aflibercept (51 percent; p=
• There were more switches from ranibizumab to aflibercept (p<
0.001) than vice versa.
• The proportion of eyes that didn’t complete three years of treatment in each of the groups was similar (p=
Researchers concluded that neither ranibizumab nor aflibercept was superior to the other in terms of VA outcomes and treatment frequency at three years for nAMD.
SOURCE: Bhandari S, Nguyen V, Arnold J, et al. Treatment outcomes of ranibizumab versus aflibercept for neovascular age-related macular degeneration: Data from the Fight Retinal Blindness! Registry. Ophthalmology 2019; Oct. 11 [Epub ahead of print].
ONH Microvascular Changes After Phacoemulsification Surgery
Investigators determined optic nerve head microvascular changes detected by optical coherence tomography angiography and intraocular pressure changes after uncomplicated phacoemulsification surgery.
The study was designed as a prospective observational study. Twenty-four eyes were included. Excluded eyes were those with retinal vascular pathology, any type of age-related macular degeneration, IOP greater than 21 mmHg, axial length less than 20 mm or more than 24 mm, corneal edema and cataracts that can disrupt images, and history of ocular surgery.
Patients underwent OCTA imaging and IOP measurement preoperatively (baseline) and postoperatively (weeks one and four). Investigators measured vessel density percentage (VD) in the total disc, peripapillary and inside disc; in addition to IOP measured with applanation tonometry. They compared VD and IOP, and correlations between VD and IOP changes. Here were some of the findings:
• VD was significantly increased in all quadrants in week four compared to week one.
• For VD and IOP, there was no significant difference between week one and baseline (p<0.05), but week four results were significantly different from baseline (p<0.001).
• The IOP was significantly lower in week four (14.8 mmHg) than in week one (16 mmHg) (p<0.001).
• There was a significant negative correlation between the inside disc and total VD and IOP at weeks one and four.
Investigators reported that phaco could result in a decrease in IOP and an increase in VD of the ONH.
SOURCE: Karabulut M, Karabulut S, Sül S, et al. Optic nerve head microvascular changes after phacoemulsification surgery.
Graefes Arch Clin Exp Ophthalmol 2019; Sep 16. [Epub ahead of print].
Subretinal Drusenoid Deposits in AMD
Scientists clarified the role of subretinal drusenoid deposits (SDDs; pseudodrusen) in the progression of age-related macular degeneration through high-resolution histology.
They assessed examples of SDDs in contact with photoreceptors in 33 eyes of 32 donors (early AMD, n=15; geographic atrophy, n=9; neovascular AMD, n=7; unremarkable, n=2), and two eyes of two donors with in vivo
multimodal imaging including optical coherence tomography. Here were some of the findings:
• SDDs were granular extracellular deposits at the apical retinal pigment epithelium; the smallest were 4-µm wide.
• Outer segment (OS) fragments and RPE organelles appeared in some larger deposits.
• A continuum of photoreceptor degeneration included OS disruption, intrusion into inner segments and disturbance of neurosensory retina.
• In transitioning to outer retinal atrophy, SDDs appeared to shrink, the OS disappeared, the inner segment shortened, and the outer nuclear layer thinned and became gliotic.
• Stage 1 SDDs on OCT correlated with displaced OS.
• Confluent and disintegrating stage 2 to 3 SDDs on OCT, and dot pseudodrusen by color fundus photography correlated with confluent deposits and ectopic RPE.
Scientists determined that subretinal drusenoid deposits might start at the RPE as granular, extracellular deposits. They wrote that photoreceptor OS, RPE organelles and cell bodies might appear in some advanced deposits, and confirmed progression to atrophy associated with deposit diminution. They added that their findings supported a biogenesis hypothesis of outer retinal lipid cycling.
SOURCE: Chen L, Messinger JD, Zhang Y, et al. Subretinal drusenoid deposit in age-related macular degeneration: Histologic insights into initiation, progression to atrophy, and imaging. Retina 2019; Oct 9. [Epub ahead of print].
Peripheral Hypertrophic Subepithelial Opacities of Corneal Grafts After DALK
Researchers looked into possible underlying etiologies of the development of peripheral graft hypertrophic subepithelial opacities (PGHSO) and evaluated the effects of these opacities on visual outcomes after deep anterior lamellar keratoplasty.
This prospective, interventional case series enrolled 29 eyes with keratoconus that underwent DALK and developed PGHSO (group 1). The control group consisted of 32 eyes with keratoconus that underwent DALK during the same period and had a clear graft at the final examination (group 2). Researchers evaluated possible underlying risk factors for the development of PGHSO, and compared postoperative refractive and topographic outcomes between the two study groups. Here were some of the findings:
• Eyes of group 1 had well-defined elevated peripheral subepithelial opacities of the corneal graft, originating from the donor-recipient junction.
• The central 4-mm area of the graft was clear in all eyes of this group.
• Compared with the controls, group 1 had flatter grafts at postoperative month one and a longer time interval from surgery to initial suture removal.
• The two study groups were comparable in certain investigated factors including the severity of keratoconus, surgical technique, duration of topical steroid use and donor quality.
• No significant differences were observed between the case and control groups in postoperative visual acuity and graft surface regularity.
Researchers found that graft flattening during the early postoperative period, and a prolonged time interval from surgery to initial suture removal, might be predisposing factors for the development of PGHSO. This complication didn’t affect postoperative visual outcomes when the central 4-mm area of the graft remained clear.
Source: Feizi S, Karjou Z, Masoudi A, et al. Peripheral hypertrophic subepithelial opacities of corneal grafts after deep anterior lamellar keratoplasty. Cornea 2019; Oct 3. [Epub ahead of print].
Optos Unveils Silverstone
At the American Academy of Ophthalmology annual meeting in San Francisco, Optos launched Silverstone, an imaging system combining ultra-widefield retinal imaging with integrated, image-guided, swept-source optical coherence tomography. Silverstone produces a 200-degree, single-capture Optomap image with guided OCT, enabling advanced OCT imaging anywhere across the retina, from posterior pole to far periphery, the company says. This provides UWF guided multimodal imaging in support of detection, investigation and monitoring of retinal disease. Learn more.
Norlase Launches Single Spot Laser
Norlase announced FDA approval of LEAF, the company’s laser therapy for the treatment of retinal and glaucoma disease. Norlase says that the device requires minimal set-up time and physical space: The entire laser unit attaches to an existing slit lamp. A wireless tablet serves as the user interface, and an optional voice control feature provides touchless parameter control during treatment. Learn more.
Sun Pharma Commercializes Cequa in U.S. for Treatment of DED
Sun Pharmaceutical Industries announced that one of its wholly-owned subsidiaries has commercialized Cequa (cyclosporine ophthalmic solution) 0.09% in the United States, although the drug was initially approved by the FDA in August 2018. Cequa is indicated to increase tear production in patients with keratoconjunctivitis sicca, and is delivered with nanomicellar (NCELL) technology, which is designed to improve the bioavailability and physicochemical stability of cyclosporine for improved ocular tissue penetration, the company says. Read more.
Annexon Reports Topline Results for Novel C1q Inhibitor in Glaucoma
Annexon Biosciences announced results from a Phase Ib dose-ranging clinical trial to evaluate its anti-C1q antibody, ANX007, in individuals with glaucoma. ANX007 is an investigational, monoclonal antibody antigen-binding fragment formulated for intravitreal administration. In the trial, Annexon says ANX007 was well-tolerated and resulted in full-target engagement and inhibition of C1q in the eye for at least four weeks following a single intravitreal treatment. Read more.
Eyenuk Receives NIH Grant to Expand AI Eye Screening Platform
Eyenuk was awarded a grant to develop a fully automated retinal image artificial intelligence solution for detection of biomarkers for neurodegenerative disorders. The grant from the National Institute of Neurological Disorders and Stroke, a part of the National Institutes of Health, supports a collaboration between Eyenuk and Los Angeles’ Cedars-Sinai Medical Center to conduct research with the goal of developing ophthalmic screening tools for early detection of neurodegenerative disorders.
PanOptica Anti-VEGF Drop Studied in nAMD Treatment
PanOptica reported positive clinical data for PAN-90806, a once-daily topical formulation of a small-molecule anti-vascular endothelial growth factor eye drop for the treatment of neovascular eye diseases. At the Ophthalmology Innovation Summit at the American Academy of Ophthalmology annual meeting, the company presented topline results from a Phase I/II dose-ranging clinical trial in which PAN-90806 demonstrated safety and biological response as monotherapy in treatment-naïve patients with neovascular age-related macular degeneration. Read more.
Eyevensys Presents Data from Phase I/II Trial of Gene Therapy
Eyevensys presented results from part one of its Phase I/II study of gene therapy for the treatment of non-infectious uveitis at the Ophthalmology Innovation Summit’s conference in San Francisco. The company’s technology is a non-viral gene therapy ocular drug delivery platform that uses a two-part electrotransfection system, including a proprietary Ocular Device and Electrical Pulse Generator that delivers DNA plasmids encoding therapeutic proteins into the ciliary muscle. This enables the ciliary muscle to produce the therapeutic protein that reaches the back of the eye, the company says. Read more.
FDA Grants ProQR Rare Pediatric Disease Designation for LCA10 Treatment
ProQR Therapeutics received Rare Pediatric Disease designation from the FDA for its drug sepofarsen for the treatment of Leber’s congenital amaurosis 10. Sepofarsen (QR-110) is an investigational RNA-based oligonucleotide designed to address the underlying cause of LCA10 due to the p.Cys998X mutation (also known as the c.2991+1655A>G mutation) in the CEP290 gene. Read more.
J&J Vision Announces New Data and Products at AAO 2019
Johnson & Johnson Vision announced a series of data, technology, and products at the American Academy of Ophthalmology Annual Meeting in San Francisco, including the FDA approval of a wavefront guided-PRK indication for its iDesign Refractive Studio and the availability of the Tecnis Simplicity Delivery System for inserting the Tecnis IOL. Read more.
ZEISS Showcases Eye-Care Digitalization at AAO 2019
At the Annual Meeting of the American Academy of Ophthalmology in San Francisco, Zeiss Medical Technology presented its latest in digital eye-care innovation and high-resolution imaging. Read more about the company’s digital advancements.
Eyevance Pharmaceuticals Acquires Tobradex ST and Natacyn
Eyevance Pharmaceuticals acquired two currently approved drugs from Novartis: Tobradex ST (tobramycin/dexamethasone ophthalmic suspension) 0.3%/0.05% and Natacyn (natamycin ophthalmic suspension) 5%. Tobradex ST (tobramycin/dexamethasone ophthalmic suspension) 0.3%/0.05%, is a fixed-dose topical antibiotic and corticosteroid combination indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists. Natacyn (natamycin ophthalmic suspension) 5% is indicated for the treatment of fungal blepharitis, conjunctivitis and keratitis caused by susceptible organisms, including Fusarium solani keratitis.
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