From the editors of Review of Ophthalmology:
JUNE IS FIREWORKS EYE SAFETY & CATARACT AWARENESS MONTH
In this issue: (click heading to view article)
Findings from The EYE-RISK Consortium
As part of a case-control association analysis, researchers aimed to identify metabolites associated with age-related macular degeneration. In addition, they looked at the effect of AMD-associated genetic variants on metabolite levels, and investigated associations between identified metabolites and activity of the complement system—one of the main AMD-associated disease pathways.
A total of 2,267 AMD cases and 4,266 controls from five European cohorts were included. Researchers used a high-throughput H-NMR metabolomics platform to quantifiy 146 metabolite measurements and 79 derivative values. They used univariate logistic regression analyses to study metabolome-AMD associations and linear regression to study the effect of 52 AMD-associated genetic variants on identified metabolites. And they used linear regression to evaluate associations between identified metabolites and activity of the complement pathway (defined by the C3d/C3 ratio). Main outcome measures included metabolites associated with AMD.
Here were some of the findings:
- Researchers identified 60 metabolites that were significantly associated with AMD, including increased levels of large and extra-large HDL subclasses and decreased levels of VLDL, amino acids and citrate.
- Out of 52 AMD-associated genetic variants, seven variants were significantly associated with 34 of the identified metabolites.
- The strongest associations were identified for genetic variants located in or near genes involved in lipid metabolism (ABCA1, CETP, APOE, LIPC) with metabolites belonging to the large and extra-large HDL subclasses.
- In addition, 57 out of 60 metabolites were significantly associated with complement activation levels, independent of AMD status.
- Increased large and extra-large HDL levels and decreased VLDL and amino acid levels were associated with increased complement activation.
Researchers found that lipoprotein levels were associated with AMD-associated genetic variants, with strong associations between most of the AMD-associated metabolites and systemic complement activation levels, independent of AMD status. They suggested this finding may indicate biological interactions between the main AMD disease pathways and that multiple pathways may need to be targeted simultaneously for successful treatment of AMD.
SOURCE: Acar IE, Lores-Motta L, Colijn JM, MD MSc, et al. Integrating metabolomics, genomics and disease pathways in age-related macular degeneration: The EYE-RISK Consortium. Ophthalmology 2020; June 13. [Epub ahead of print].
Complimentary CME Education Videos
Citicoline Eyedrops for Glaucoma
Investigators assessed whether additional therapy with citicoline eyedrops to intraocular pressure-lowering treatment could slow glaucoma progression in patients with worsening of damage and IOP 18 mmHg or less, as part of a randomized, double-masked, placebo-controlled, multicenter three-year study.
Main outcome measures were differences in visual field (MD of 24-2; MD of 10-2) rates of progression and differences in retinal nerve fiber layer thickness changes between the two study groups at three years.
Patients with mild to moderate open-angle glaucoma showing damage progression of at least -0.5 dB/y in the two years before enrollment despite IOP ≤18 mmHg were randomized to receive citicoline eyedrops or placebo three times daily for three years. Patients were followed every three months and underwent visual field exams with 24-2 and 10-2 strategies and RNFL assessment. ANOVA and linear models were used to test the differences between groups.
Eighty patients were randomized in the trial. Here were some of the findings:
- Mean three-year rates of progression were:
- for 24-2 MD: -1.03 (2.14) dB in the citicoline group and -1.92 (2.23) dB in the placebo group (p=0.07); and
- for 10-2 MD -0.41: (3.45) dB in citicoline group and -2.22 (3.63) dB in the placebo group (p=0.02).
- On average patients receiving citicoline eye drops lost 1.86 µm of RNFL in three years vs. 2.99 µm in the placebo group (p=0.02).
Investigators concluded that adding treatment with citicoline eye drops to IOP-lowering treatment might reduce disease progression in individuals with progressing glaucoma despite IOP ≤18 mmHg.
SOURCE: Rossetti L, Iester M, Tranchina L, et al. Can treatment with citicoline eyedrops reduce progression in glaucoma? The results of a randomized placebo-controlled clinical trial. J Glaucoma 2020; June 11. [Epub ahead of print].
Complimentary CME Education Videos
Intravitreal Anti-VEGF Cost Savings with Increased Bevacizumab Reimbursement & Utilization
Scientists modeled Medicare Part B and patient savings associated with increased bevacizumab payment and utilization for intravitreal anti-vascular endothelial growth factor therapy, as part of a cost analysis.
They used Medicare claims and IRIS Registry data to calculate Medicare Part B expenditures and patient co-pays for anti-VEGF agents with increasing reimbursement and utilization of bevacizumab relative to ranibizumab and aflibercept. Main outcome measures included Medicare Part B costs and patient co-pays for anti-VEGF agents in the Medicare fee-for-service population.
The scientists found that increasing bevacizumab reimbursement to $125.78—equalizing the dollar margin with aflibercept—would result in Medicare Part B savings of $468 million and patient savings of $119 million, with a 10 percent increase in bevacizumab market share.
The scientists reported that increased utilization of bevacizumab, achievable with increased reimbursement to eliminate the financial disincentive to its use, would result in substantial savings to the Medicare Part B program and to patients receiving anti-VEGF intravitreal injections.
SOURCE: Glasser DB, Parikh R, Flora Lum F, et al. Intravitreal anti-vascular endothelial growth factor cost savings achievable with increased bevacizumab reimbursement and utilization. Ophthalmology 2020; June 13. [Epub ahead of print].
Baseline Findings from the Retrospective Digital Computer Analysis of Keratoconus Evolution (REDCAKE) Project
Researchers presented baseline data for a large cohort of keratoconus patients enrolled in the Retrospective Digital Computer Analysis of Keratoconus Evolution (REDCAKE) study.
Eight centers contributed Scheimpflug tomographical data for 906 patients with keratoconus, 743 measured with a Pentacam and 163 with a Galilei. Researchers analyzed the stage of keratoconus at baseline, location of the reference points, minimum pachymetry (Pmin) and maximum keratometry (Kmax). They evaluated intereye asymmetry for Kmax (anterior and posterior), Pmin and keratoconus stage. They calculated average maps and elevation profiles for each degree of keratoconus. Here were some of the findings:
- Keratoconus was more frequently diagnosed in men (73 percent) than in women (27 percent).
- At baseline, 500/1,155 eyes (43 percent) presented with moderate to severe changes in the posterior surface, whereas moderate/severe changes were only found in 252 eyes when evaluating anterior surface and 63 eyes when evaluating pachymetry.
- The location of Pmin was usually inferotemporal (94 percent OD and 94 percent OS), while the location of Kmax showed more variability and significantly higher distance from apex (p<0.05).
- The keratoconus presentation was chiefly asymmetric for all the parameters studied.
- Clear differences between stages could be identified in the maps and elevation profiles.
Researchers found that the staging map set could be used as a graphical guidance to classify keratoconus stage. They added that keratoconus presented asymmetrically, and generally the posterior surface was more affected than the anterior surface or thickness. Researchers noted that asymmetry played a role in KC detection, and although Pmin was almost invariably located inferotemporally, Kmax location showed higher variability and distance from the apex.
SOURCE: Jiménez-García M, Ní Dhubhghaill S, Koppen C, et al. Baseline findings in the Retrospective Digital Computer Analysis of Keratoconus Evolution (REDCAKE) project. Cornea 2020; June 10. [Epub ahead of print].
Tarsus Announces Results from Mars Study
Tarsus Pharmaceuticals announced results from its Phase IIa Mars Study. The company says that Mars demonstrated that the use of TP-03 for four weeks was well-tolerated and showed promising efficacy in the treatment of demodex blepharitis, with treatment effects persisting for at least 90 days. Mars was a single-arm, open-label study that evaluated the safety and efficacy of TP-03 in 15 participants with demodex blepharitis. Read more.
FDA Approves Updated Novartis Beovu Label
Novartis announced the FDA approved a label update for Beovu (brolucizumab) to include additional safety information regarding retinal vasculitis and retinal vascular occlusion. This approval follows Novartis’ announcement that it would pursue worldwide label updates after a review and further characterization of rare post-marketing Beovu safety events. The company says this is one of many efforts it’s taking to help physicians to make informed decisions on the use of Beovu, including the establishment of an internal team collaborating with global experts to examine root causes, risk factors, mitigation and potential treatment protocols for the adverse events in question. Read more.
IVERIC Announces Zimura 18-month Data
IVERIC bio announced 18-month results from the company's first Phase III clinical trial (OPH2003) for Zimura (avacincaptad pegol), a novel complement C5 inhibitor, for the treatment of geographic atrophy secondary to age-related macular degeneration. The company says that the 18-month data supports the previously announced 12-month data from this trial, at which timepoint Zimura met the pre-specified primary efficacy endpoint with statistical significance. Read more.
Santen and Orbis Offer Telemedicine Training
Santen and Orbis International recently announced a partnership to develop a suite of digital training tools that will continue to help eye-care professionals around the world build their skills. Through the three-year, global partnership, the two companies will create online courses, live surgical demonstrations and artificial intelligence systems focused on glaucoma. Read more.
Hilco Vision Acquires Suppleyes
Hilco Vision acquired Mississippi-based ophthalmic supplies company Suppleyes, effective June 1. Hilco Vision is a global eyewear/eye care company with direct subsidiaries, including Eye Care and Cure, in the United States, Canada, the UK, Germany, Australia, China and the Netherlands. Read more.
Study with Patient-operated Home OCT Begins
Notal Vision announced the enrollment of patients in the first longitudinal home-based study with its investigational home optical coherence tomography remote monitoring device. The study will explore the daily dynamics of retinal fluid in patients receiving anti-VEGF treatment for wet age-related macular degeneration. Read more.
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