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| Vol. 20, #42 • Monday, October 5, 2020 |
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OCTOBER IS HALLOWEEN SAFETY MONTH
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Long-term Anti-VEGF Treatment for nAMD: The LATAR Study
Researchers reported 10-year outcomes of eyes with neovascular age-related macular degeneration treated with vascular endothelial growth factor inhibitors as part of a 10-year, retrospective cohort study. Participants included 1,046 individuals who started treatment with anti-VEGF for nAMD.
Anti-VEGF-naïve eyes diagnosed with nAMD starting treatment between November 2006 and December 2009 were identified. Data collected included baseline demographics, visual acuity and the number of intravitreal injections. Baseline fundus fluorescein angiograms and optical coherence tomography images were graded for choroidal neovascularization type, and OCT images also were graded for central macular thickness and presence of fluid over 10 years.
Main outcome measures included the change in vision at 10 years, the proportion of eyes with either 20/40 vision or better, or 20/200 or worse; the percentage of eyes that were dry on OCT imaging and the number of injections.
From 1,046 eligible eyes, 10-year data were available for 293 eyes (28 percent), which were included in the analyses. Here were some of the findings:
• Eyes received 58.1 (SD: 23.6) injections during the 10 years.
• The mean central macular thickness decreased from 355.5 ±107.8 μm to 264.2 ±79.5 μm (p<0.001).
• The median baseline VA was 60 (IQR: 45 to 70) letters, which improved by 9 (IQR: 1 to 14) letters after the first year of treatment (p<0.001).
• Over the 10-year period, initial gains were lost over time, with a final VA change of +3 letters (IQR: 8 to 10 letters; p=0.162).
• The percentage of eyes with VA 20/40 or better increased from 29 percent at baseline to 35 percent at 10 years (p<0.001).
• The percentage of eyes at baseline with VA 20/200 or worse was 14 percent at baseline and 17 percent at 10 years.
Researchers wrote that, on average, eyes with nAMD maintained baseline VA when treated with VEGF inhibitors for 10 years. With ongoing regular treatment, a greater proportion of eyes achieved VA of 20/40 or better at 10 years than at presentation.
SOURCE: Spooner K, Fraser-Bell S, Hong T, et al. Long-term anti-VEGF treatment for neovascular age-related macular degeneration. The LATAR study report 1: Ten-year, real-world outcomes. Ophthalmol Retina 2020; Sept 29. [Epub ahead of print].
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Complimentary CME Education Videos
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CCT By Scheimpflug Imaging vs. Ultrasound in Keratoconus
Investigators evaluated the agreement of central corneal thickness (CCT) measurements between Scheimpflug imaging and ultrasound pachymetry in keratoconic eyes, and they assessed factors impacting the agreement.
This post hoc analysis within a prospective, observational non-randomized study preformed at Toronto’s Kensington Eye Institute included cross-linking candidates with progressive keratoconus. Main outcome measures were the agreement of CCT measurements between Scheimpflug imaging (Pentacam, Oculus) and U/S pachymetry (PachPen 24-5100, Accutome).
A total of 794 keratoconic eyes of 456 subjects with a mean age of 27.6 ±8 years (69.7 percent males and 49.6 percent right eyes) were included. Here were some of the findings:
• Agreement between devices was moderate (intraclass correlation coefficient: 74.9 percent; Bland-Altman limits of agreement: -48.5 to +62.5 μm).
• In a multivariable analysis, cone decentration (p<0.001, coefficient +10.13 [CI, +6.73 to +13.53]) and Kmax (p<0.001, coefficient +0.68 [CI, +0.46 to +0.90]) were significantly associated (clinically and statistically) with the level of agreement between the devices; the discrepancy in CCT between the devices increased on average by 10.13 μm for every millimeter of cone decentration, and by 6.8 μm for every 10 D of Kmax.
• Age, corneal astigmatism and spherical equivalent were statistically, but not clinically, significant factors affecting agreement.
Investigators found that the agreement of CCT measurements between Scheimpflug imaging and U/S pachymetry in keratoconus was moderate. They wrote that, to ensure the safety of crosslinking in keratoconic corneas, Scheimpflug and U/S CCT measurements shouldn’t be used interchangeably, especially in steep corneas and corneas with decentered cones.
SOURCE: Sorkin N, Ohri A, Jung H, et al, KEI CXL Working Group. Factors affecting central corneal thickness measurement agreement between Scheimpflug imaging and ultrasound pachymetry in keratoconus. Br J Ophthalmol 2020; Sep 24. [Epub ahead of print].
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Complimentary CME Education Videos
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Quantitative Comparison of Four OCTA Devices in Healthy Eyes
A number of FDA-approved optical coherence tomography angiography devices are commercially available, each with unique algorithms and scanning protocols. Although several published studies have compared different combinations of OCTA devices, a lack of agreement exists on the consistency of measurements across OCTA devices. Therefore, scientists conducted a prospective, quantitative comparison of four available OCTA platforms.
Subjects were scanned on four devices: the Optovue RTVue-XR; Heidelberg Spectralis OCT2 module; Zeiss Plex Elite 9000 Swept-Source OCT; and Topcon DRI-OCT Triton Swept-Source OCT. Images (3 × 3 mm) were used for analysis. Foveal avascular zone (FAZ) area was separately and independently measured by two investigators. Scientists calculated fractal dimension (FD), superficial capillary plexus (SCP) and deep capillary plexus (DCP) vessel densities (VDs) from binarized images using Fiji image processing software. SCP and DCP VDs were further calculated after images were skeletonized. Scientists performed repeated measurements of analysis of variance (ANOVA), post hoc tests and interclass correlation coefficient (ICC) for statistical analysis.
Sixteen healthy eyes from 16 individuals were scanned on the four devices. Images of five eyes from the Triton device were excluded due to poor image quality; thus, the authors performed two sets of comparisons—one with and one without the Triton machine. The FAZ area showed no significant difference across devices, with an ICC of >95 percent. However, scientists found statistically significant differences for SCP and DCP VDs both before and after skeletonization (p<0.05). Fractal analysis revealed no significant difference for FD at the SCP; however, a statistically significant difference was found for FD at the DCP layer (p<0.05).
Scientists determined that FAZ measurements were consistent across all four devices, but there were significant differences in VD and FD measurements. They suggested that, for both clinical follow-up and research studies, FAZ area may be a useful parameter for OCTA image analysis when measurements are made on different devices, while VD and FD show significant variability when measured across devices.
SOURCE: Lu Y, Wang JC, Cui. Y, et al. A quantitative comparison of four optical coherence tomography angiography devices in healthy eyes. Graefes Arch Clin Exp Ophthalmol 2020; Sep 25. [Epub ahead of print].
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Perimetric Loss at Different Target IOPs for HTG and NTG
Researchers compared forecasted mean deviation changes on perimetry in individuals with normal-tension glaucoma and high-tension glaucoma at different target intraocular pressures using a machine learning technique called Kalman Filtering (KF).
The retrospective cohort study included 496 participants with HTG from the Collaborative Initial Glaucoma Treatment Study or the Advanced Glaucoma Intervention Study, and 262 individuals with NTG from Japan.
Using the first five sets of tonometry and perimetry measurements, researchers classified each individual as a fast-progressor, slow-progressor or non-progressor. Using KF, they generated personalized forecasts of MD changes on perimetry over 2.5 years of follow-up for fast-progressors and slow-progressors with HTG and NTG whose IOPs were maintained at hypothetical IOP targets of 9 to 21 mmHg. They also assessed future MD loss with different percentage reductions in IOP from baseline (0 to 50 percent) for the groups. Main outcome measures included mean change in forecasted MD at different target IOPs.
The mean age of patients were 63.5 ±10.5 years in NTG and 66.5 ±10.9 years in HTG. Here were some of the findings:
• At target IOPs of 9, 15 and 21 mmHg, over 2.5 years of follow-up:
o fast progressors with NTG had mean forecasted MD losses of 2.3 ±0.2, 4 ±0.2 and 5.7 ±0.2 dB, respectively; and
o slow progressors had mean forecasted MD losses of 0.63 ±0.02, 1.02 ±0.03, and 1.49 ±0.07 dB, respectively.
• At target IOPs of 9, 15, and 21 mmHg, over 2.5 years of follow-up:
o fast progressors with HTG had mean forecasted MD losses of 1.8 ±0.1, 3.4 ±0.1 and 5.1 ±0.1 dB, respectively; and
o slow progressors had mean forecasted MD losses of 0.55 ±0.06, 1.04 ±0.08 and 1.59 ±0.10 dB.
• Fast progressors with NTG experienced a greater MD decline than fast progressors with HTG at each target IOP (p≤0.007 for all).
• The MD decline for slow progressors with HTG and NTG was similar at each target IOP (p≥0.24 for all).
• Fast progressors with HTG experienced greater MD loss than those with NTG, with IOP reductions of 0 to 10 percent from baseline (p≤0.01 for all) but not 25 percent (p=0.07) or 50 percent (p=0.76).
Researchers wrote that machine learning algorithms using KF techniques demonstrate promise for forecasting future values of MD at different target IOPs for individuals with NTG and HTG.
SOURCE: DeRoos L, Nitta K, Lavieri MS, et al. Comparing perimetric loss at different target intraocular pressures for patients with high tension and normal tension glaucoma. Ophthalmol Glaucoma 2020; Sep 17. [Epub ahead of print].
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Industry News
J&J Vision Introduces Tecnis Synergy Toric II IOL and Catalys System cOS 6.0 for Cataract Patients with Astigmatism, at ESCRS 2020
Johnson & Johnson Vision will launch Tecnis Synergy Toric II IOL with the Tecnis Simplicity Delivery System, a continuous-range-of-vision intraocular lens engineered for rotational stability, at the virtual European Society of Cataract and Refractive Surgeons 2020 annual meeting, October 2 to 4. In addition, the company will present the first clinical research findings on Tecnis Synergy and the Tecnis Toric II platform, as well as additional clinical outcomes and studies. The company also will launch Catalys System cOS 6.0 software for the company’s femtosecond laser, which offers new features for astigmatism-management workflow. Read more.
FDA Approves B+L Alaway Preservative-free Ophthalmic Solution, 0.035%
Bausch Health Companies, Bausch + Lomb and Eton Pharmaceuticals announced the FDA approved Alaway Preservative Free (ketotifen fumarate) ophthalmic solution 0.035%, antihistamine eye drops (EM-100), as the first over-the-counter, preservative-free formulation eye drop approved to temporarily relieve itchy eyes due to pollen, ragweed, grass, animal hair and dander. Preservatives commonly used in eye drops can cause allergic reactions in some people that can lead to redness, irritation, itching or tearing. B+L says Alaway Preservative Free is formulated to relieve itch within minutes and can provide up to 12 hours of itch relief with one dose. Read more.
FDA Accepts Aerie’s IND Application for AR-15512 (TRPM8 Agonist) Eye Drop for DED
Aerie Pharmaceuticals announced the FDA accepted its Investigational New Drug Application for AR-15512 (TRPM8 agonist) eye drop for dry eye, enabling the company to initiate clinical studies. The active ingredient in AR-15512 is a selective agonist of the TRPM8 cold thermoreceptor ion channel that regulates tear production and blink rate. Aerie expects to initiate a Phase IIb clinical study in the fourth quarter of 2020. Read more.
First Patients Dosed in Ocular Therapeutix Phase II OTX-CSI Trial
Ocular Therapeutix announced the first patients were dosed in its Phase II clinical trial of OTX-CSI (cyclosporine intracanalicular insert) for the treatment of dry eye. The Phase II trial is a U.S.-based, randomized, masked, multicenter trial evaluating two different formulations of OTX-CSI with vehicle insert in approximately 105 subjects who will be followed for 16 weeks. Read more.
Visus Launches Clinical Development Program for Presbyopia Eye Drop
Visus Therapeutics initiated development of a novel eye drop designed to restore the loss of near vision associated with presbyopia. Visus’ lead product candidate Brimochol, is a proprietary formulation that combines two FDA-approved pharmaceuticals: carbachol and brimonidine tartrate. Read more.
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