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| Vol. 22, #26 • Monday, June 21, 2021 |
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JUNE IS FIREWORKS EYE SAFETY & CATARACT AWARENESS MONTH
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A message from Review’s Chief Medical Editor, Mark H. Blecher, MD:
I’m insulted by the recent “Special Fraud Alert” from CMS that the OIG issued regarding industry-sponsored and -supported educational programs.1 The advisory focuses on egregious behavior long past, and in specialties far from ophthalmology, yet they present this as a current and ever-present danger. They ignore the sea change of policy encompassed in the PhRMA and AdvaMed codes—self-imposed regulations implemented by almost every industry player in ophthalmology. These were a response to earlier concerns, more than a decade ago, and are still rigorously applied, in ophthalmology at least.
Spending money to market a product is part of our economic model. Engaging experts to educate about these products makes perfect sense. Allowing the target audience to use their intelligence and training to sort these inputs and make appropriate decisions should be the expected outcome. Not allowing a rep to buy you a cup of coffee on the assumption that this will change how you care for patients is beyond insulting. All of the products in question, whether drugs or devices, have been thoroughly vetted and FDA approved to be safe and effective. Why in medicine are physicians treated like children and have proscriptions imposed far beyond any other profession? For instance, have you seen the legal ‘conferences’ sponsored by special interests and corporations? There will always be outliers who should be dealt with, and they have been. It would be more appropriate and useful to target the transgressors than sully an entire industry and an entire profession.
Addendum: I consult for industry, receive payment for my time, and am proud of the work I’ve been asked to do. No one has offered me a vacation for my family, incentives to use products or spent $500 for my dinner.
Mark H. Blecher, MD
Chief Medical Editor
Review of Ophthalmology
1.https://oig.hhs.gov/fraud/docs/alertsandbulletins/2020/SpecialFraudAlertSpeakerPrograms.pdf
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Characteristics of Central VF Progression in Eyes with Optic Disc Hemorrhages
Researchers assessed the characteristics and rate of central visual field loss after optic disc hemorrhages, as part of a prospective cohort study.
A total of 343 eyes of 220 subjects who had at least three years of follow-up with a minimum of five visits with 10-2 and 24-2 visual field (VF) were recruited. Rates of 10-2 mean deviation (MD) loss in each hemifield and pre-defined zones were compared using a linear mixed-effects model in DH and non-DH eyes. Clustered pointwise regression analysis defined central VF progressors, and researchers compared findings to 24-2 VF loss using Guided Progression Analysis.
A total of 39 eyes with DHs and 304 eyes without DHs had a mean follow-up of 5.2 years. Here were some of the findings:
• Eyes with DHs had rates of 10-2 mean deviation (MD) loss that were three times faster than non-DH eyes (mean difference [CI] -0.36 dB/year [0.54, 0.18; p<0.001) and were 3.7 times more likely to progress (p=0.002).
• A larger proportion of glaucomatous eyes showed central VF progression rather than peripheral VF progression in the DH group (30.8 percent vs. 20.5 percent) compared with the non-DH group (10.9 percent vs. 9.2 percent).
• In early glaucoma, the rate of 10-2 MD loss was 5.5 times faster in DH eyes than in non-DH eyes (p<0.001).
• Superonasal and superotemporal central VF regions progressed more rapidly than other regions, especially in DH eyes.
Researchers found that central visual field loss was accelerated in glaucoma eyes with optic disc hemorrhages and corresponded topographically to the DH location. They suggested that for glaucoma patients with DHs, clinicians should consider supplementing 10-2 VFs with 24-2 VFS to monitor disease.
SOURCE: David RCC, Moghimi S, Do JL, et al. Characteristics of central visual field progression in eyes with optic disc hemorrhage. Am J Ophthalmol 2021; Jun 6:S0002-9394(21)00320-2.
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GA Incidence and Progression Following Intravitreal Injections of Anti-VEGF Agents for AMD
Since geographic atrophy can occur in advanced neovascular age-related macular degeneration, researchers sought to estimate the incidence and progression of GA following intravitreal injections of anti-vascular endothelial growth factor agents in eyes with nAMD.
The investigators searched Ovid MEDLINE, Embase and Cochrane Central from inception to May 2020. They included studies that reported on the progression or development of GA in eyes with nAMD following anti-VEGF therapy.
They found 31 articles consisting of 4,609 study eyes (4,501 patients). Eyes received a mean of 17.7 injections over 35.2 months. Here are some of the findings:
• The prevalence of GA at baseline was 9.7 percent.
• The pooled incidence of GA was 30.5 percent at the end of follow-up.
• There was a positive, moderate linear correlation between the mean total number of injections and GA incidence at final follow-up (R2=0.30; p=0.01).
• Monthly treatment was associated with a significantly higher risk for GA development relative to PRN (RR=1.40, CI, 1.21 to 1.61; p<0.001).
• Risk factors for GA development included GA in the fellow eye, retinal angiomatous proliferation, drusen and reticular pseudodrusen.
Investigators found an association between the frequency and number of treatments with anti-VEGF agents and the development of GA in nAMD. They suggested that future studies should clarify risk factors, population characteristics, and the relative contributions of treatment and disease progression on GA development in this context.
SOURCE: Eshtiaghi A, Issa M, Popovic MM, et al. Geographic atrophy incidence and progression following intravitreal injections of anti-vascular endothelial growth factor agents for age-related macular degeneration: A meta-analysis. Retina 2021; May 17. [Epub ahead of print].
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Complimentary CME Education Videos
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Evaluating Dry-eye Subtypes and Characteristics
Scientists evaluated subtypes and characteristics of dry eye using conventional tests and dynamic tear interferometry, and reported determinants of disease severity in each DE subtype.
A total of 309 patients were diagnosed with DE, and 69 healthy controls were prospectively enrolled. All eyes were evaluated using the Ocular Surface Disease Index (OSDI), Schirmer’s test I (ST1) and meibomian gland dysfunction (MGD) grade. The tear interferometric pattern and lipid layer thickness were determined using DR-1α and LipiView II, respectively.
Here are some of the findings:
• Dynamic interferometric analysis revealed 56.6 percent of patients with DE exhibited Jupiter patterns, indicative of aqueous-deficiency, while 43.4 percent exhibited crystal patterns, indicative of lipid deficiency. These findings were in accordance with classification based on ST1 scores and MGD grade.
• Conventional assessment indicated 286 patients exhibited evidence of evaporative DE (EDE) due to MGD, while 11 exhibited signs of pure aqueous-deficient DE (pure ADDE, only ST1 ≤5 mm).
• Of 286 patients with EDE, 144 were categorized into the mixed-ADDE/EDE group, in which ST1 was identified as a strong negative determinant of OSDI.
• In contrast, 72.2 percent of patients with mixed-ADDE/EDE exhibited Jupiter patterns (Jupiter-mixed), while 27.8 percent exhibited crystal patterns (crystal-mixed).
• OSDI values were significantly higher in the crystal-mixed group than in the Jupiter-mixed where OSDI scores were independently associated with ST1 values only.
Scientists reported that the majority of EDE patients also exhibited aqueous deficiency, which can aggravate symptoms in patients with lipid-deficient mixed-ADDE/EDE. They recommended that conventional assessments be combined with interferometric tear analysis to determine the most appropriate treatment for each DE patient.
SOURCE: Ji YW, Seong H, Seo JG, et al. Evaluation of dry eye subtypes and characteristics using conventional assessments and dynamic tear interferometry. Br J Ophthalmol 2021; Jun 9. [Epub ahead of print].
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Predicting Short-term Anti-VEGF Treatment Effects in nAMD
Researchers predicted short-term anti-vascular endothelial growth factor treatment responders/non-responders for neovascular age-related macular degeneration patients based on optical coherence tomography images.
A total of 4,944 OCT scans from 206 patients with nAMD were the basis of a responder/non-responder prediction method for the short-term effect of anti-VEGF therapy. A deep learning architecture named a “sensitive structure-guided network (SSG-Net)” was created for prediction using pre- and post-treatment images. To verify its clinical efficiency, two deep learning methods and four experienced ophthalmologists evaluated the performance of the developed model.
Here are some of the findings:
• For the testing dataset, SSG-Net could predict the response by an accuracy of 84.6 percent and an area under the receiver curve (AUC) of 0.83, with a sensitivity of 0.692 and specificity of 1.
• In contrast, one comparison deep learning method achieved an accuracy of 65.4 percent with a sensitivity of 0.461 and specificity of 0.846; and the other achieved an accuracy of 73.1 percent with a sensitivity of 0.692 and specificity of 0.846.
• The predicted accuracy for four experienced ophthalmologists was 53.8 to 76.9 percent, with sensitivity of 0.538 to 0.923, and specificity of 0.385 to 0.846, respectively.
Researchers wrote that the proposed SSG-Net was effective in predicting the short-term efficacy of anti-VEGF treatment for nAMD patients. They noted that the technique could possibly help clinicians explain the necessity of anti-VEGF treatment to potential responders and avoid unnecessary treatment for non-responders.
SOURCE: Zhao X, Zhang X, Lv B, et al. Optical coherence tomography-based short-term effect prediction of anti-vascular endothelial growth factor treatment in neovascular age-related macular degeneration using sensitive structure guided network. Graefes Arch Clin Exp Ophthalmol 2021; Jun 7. [Epub ahead of print].
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Industry News
Clearside Announces Safety Results from Cohort 1 of OASIS
Clearside Biomedical says OASIS, its ongoing Phase I/IIa clinical trial of CLS-AX (axitinib injectable suspension) administered by suprachoroidal injection via Clearside’s SCS Microinjector in six patients (n=6) with neovascular age-related macular degeneration has shown good safety in one cohort. The primary endpoints were achieved in Cohort 1, as the initial lowest planned dose of 0.03 mg CLS-AX was well-tolerated, with no serious adverse events and no drug-related treatment emergent adverse events observed throughout the study period, the company says. Read more.
Prevent Blindness to Present 2021 Person of Vision Award to Marc Ferrara
Prevent Blindness will present its 2021 Person of Vision Award to Marc Ferrara, CEO of Information Services, Jobson Medical Information, on Sept. 23, in conjunction with Vision Expo West. The Person of Vision event will be held at the Sands Expo & Convention Center, Las Vegas, beginning at 6:30 p.m. PT. Dinner will be served at 7:30 p.m., with the program and award presentation beginning at 8:30 p.m. The Prevent Blindness Person of Vision Award recognizes an individual or organization whose inspired outlook champions healthy vision and its importance for a healthy life. Marc Ferrara was chosen as the 2021 Prevent Blindness Person of Vision Award recipient due to his extensive work and decades-long dedication to the vision industry. Ferrara has volunteered in several capacities at Prevent Blindness, including serving on various fundraising event committees such as the annual Prevent Blindness Swing Fore Sight golf outings and for past Person of Vision Award dinners. The Prevent Blindness Person of Vision Committee is co-chaired by Marge Axelrad, senior vice president, editorial director at Vision Monday/Jobson Optical Group, and Jim McGrann, chairman and CEO of Healthy Eyes Advantage. The 2021 Person of Vision Award event was rescheduled to be held at this year’s Vision Expo West after cancellation of Vision Expo East in New York. All proceeds from the 2021 event will go to support the sight-saving programs of Prevent Blindness. Register for the event and learn about sponsorship opportunities.
Biogen Fails to Meet Endpoints in Phase III Gene Therapy Study
Biogen announced its Phase III STAR study of timrepigene emparvovec (BIIB111/AAV2-REP1), an investigational gene therapy for the potential treatment of choroideremia, didn’t meet its primary endpoint of proportion of participants with a ≥15 letter improvement from baseline in best-corrected visual acuity at month 12, in the interventional group compared to the non-interventional control group, as measured by the Early Treatment of Diabetic Retinopathy Study chart. In addition, the study didn’t demonstrate efficacy on key secondary endpoints. Read more.
Arnaud Lacoste Named Chief Scientific Officer of Aurion
Arnaud Lacoste, MBA, PhD, was named chief scientific officer of Aurion Biotech, a company working on different therapies for blindness. The company’s first candidate is a cell therapy for the treatment of corneal endothelial dysfunction, invented by Japan’s Shigeru Kinoshita, MD, PhD. Read more.
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