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| Vol. 22, #21 • Monday, May 24, 2021 |
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MAY IS HEALTHY VISION MONTH
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A Message from Review's Chief Medical Editor:
Bytes or Bits (of Print)
Some of you may have noticed that not only have I resumed my musings in print
in Review of Ophthalmology, but I’m appearing here on our digital newsletter as
well. Clearly, I’m not going quietly into the good night.
The concept of Review, in all its forms, is to present a carefully considered
distillation—or, as my Facebook ads would say, “present a carefully curated
collection”—of what we need to know as ophthalmologists. Readership studies,
surveys, industry support and anecdotal evidence validates your appreciation for
our approach. Fortunately for us, MDs in general, and ophthalmologists in
particular, repeatedly say that they still prefer print media for acquiring their
medical information. We’re all too busy to read everything or attend every
conference. At the same time, though, we don’t want to miss anything important,
hence our magazine’s vital service to the profession. Therefore, despite the ever
more omnipresent digital media, perusing print journals still occupies a large part
of our time.
Of course, as if you needed more evidence, COVID demonstrated that online
information in all its forms is also vital to staying current and staying in touch.
Obviously, our ability to provide more current news is aided by our weekly
newsletter—but what do you prefer? Are print and digital mutually exclusive? In
truth, they serve somewhat different purposes. The print magazine’s longer, in-
depth distillations of new medical topics, as well as reviews of longstanding
topics, is rather different than the hot-off-the-press, heads-up collection of news
and medical studies that we can present electronically.
My question is: Which do you value more, and has there been any notable shift of late, given our new dependence on our laptops and other devices? Be sure to let us know.
Mark H. Blecher, MD
Chief Medical Editor
Review of Ophthalmology
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Peripapillary Choriocapillaris in NTG, POAG and Controls
Researchers quantitatively evaluated the peripapillary choriocapillaris in normal- tension glaucoma, primary open-angle glaucoma and control eyes using optical coherence tomography angiography.
Ninety eyes (30 controls, 30 NTG and 30 POAG) from 73 patients were imaged using the Zeiss Plex Elite 9000. Five repeat 3×3 mm OCTA scans were acquired nasally and temporally to the optic disc, and subsequently averaged. Four choriocapillaris flow deficit (FD) measures were calculated using the fuzzy C-means approach: FD density (FDD), mean FD size (MFDS), FD number (FDN) and FD area (FDA).
Here were some of the findings:
• Temporal NTG choriocapillaris parameters were associated with visual field index and mean deviation (p<0.05).
• The control group showed a significantly lower:
o nasal FDD (nasal: 3.79 ±1.26 percent; temporal: 4.48 ±1.73 percent; p=0.03);
o FDN (nasal: 156.43 ±38.44; temporal: 178.40 ±45.68; p=0.02); and
o FDA (nasal: 0.22 ±0.08; temporal 0.26 ±0.10; p=0.03) when compared to temporal optic disc.
• The NTG group showed a significantly higher:
o FDD (NTG: 5.04 ±2.38 percent; control: 3.79 ±1.26 percent; p=0.03);
o FDN (NTG: 185.90 ±56.66; control: 156.43 ±38.44; p=0.04); and
o FDA (NTG: 0.30 ±0.14 mm2; control: 0.22 ±0.08 mm2; p=0.03) nasal to the optic disc compared to controls.
Researchers wrote that the association between choriocapillaris parameters and glaucoma severity in NTG, but not POAG subjects, suggests vascular abnormalities may be a potential factor in the multifactorial process of glaucoma damage in NTG patients.
SOURCE: Bhalla M, Heisler M, Mammo Z, et al. Investigation of the peripapillary choriocapillaris in normal tension glaucoma, primary open angle glaucoma, and control eyes. J Glaucoma 2021; Apr 28. [Epub ahead of print].
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Efficacy & Safety of Biosimilar FYB201 Compared with Ranibizumab in nAMD
Investigators assessed the clinical equivalence of the proposed biosimilar FYB201 and reference ranibizumab in individuals with treatment-naive, subfoveal choroidal neovascularization caused by neovascular age-related macular degeneration.
This prospective, multicenter, evaluation-masked, parallel-group, 48-week, Phase III randomized study included 477 patients randomly assigned to receive FYB201 (n=238) or reference ranibizumab (n=239).
Patients received FYB201 or ranibizumab 0.5 mg by intravitreal injection in the study eye every four weeks.
The primary endpoint was change from baseline in best-corrected visual acuity by Early Treatment Diabetic Retinopathy Study (ETDRS) letters at eight weeks prior to the third monthly intravitreal injection. Biosimilarity of FYB201 to its originator was assessed via a two-sided equivalence test, with an equivalence margin in BCVA of three ETDRS letters.
Here were some of the findings:
• BCVA improved in both groups, with a mean improvement of +5.1 (FYB201) and +5.6 (reference ranibizumab) ETDRS letters at week eight.
• The analysis of covariance (ANCOVA) least squares mean difference for the change from baseline between FYB201 and reference ranibizumab was -0.4 ETDRS letters; CI, -1.6 to 0.9.
• The primary endpoint was met, as the CI was within the predefined equivalence margin.
• Adverse events were comparable between treatment groups.
Investigators found that the FYB201 biosimilar referenced ranibizumab in terms of clinical efficacy, and ocular and systemic safety in the treatment of patients with nAMD.
SOURCE: Holz FG, Oleksy P, Ricci F, et al.; COLUMBUS-AMD Study Group. Efficacy and safety of biosimilar FYB201 compared with ranibizumab in neovascular age-related macular degeneration. Ophthalmology 2021; May 3. [Epub ahead of print].
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Complimentary CME Education Videos
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A Risk Prediction Model for Endothelial Keratoplasty After Uncomplicated Cataract Surgery in Fuchs’
Scientists developed a risk prediction model for endothelial keratoplasty after uncomplicated cataract surgery in Fuchs’ endothelial corneal dystrophy using Scheimpflug imaging, as part of a prospective, observational cohort study.
The study was conducted at the Ramón y Cajal University Hospital (Madrid, Spain) on 127 eyes from 93 consecutive patients with vision loss, Fuchs’ and cataracts.
Scientists assessed the corneas using Scheimpflug imaging pachymetry and elevation maps for loss of regular isopachs, displacement of the thinnest point and posterior surface depression, according to the Mayo Clinic subclinical corneal edema classification. They also recorded other preoperative data.
The primary endpoint was the need for EK after uncomplicated phacoemulsification within two years (median duration, 18 months). Scientists calculated the risk using hazard ratios and the Kaplan-Meier cumulative incidence risk.
Here were some of the findings:
• Forty-four participants required EK, and those eyes with one, two or all three tomographic features had a hazard risk of 21.8, 57.2 and 76.5, respectively (p<0.005), compared with those eyes with normal tomographic patterns.
• The best predictive model was based on the number of tomographic features simultaneously present in an eye and the central corneal thickness at the pupillary center.
• Scientists aimed to develop a risk score from 0 to 8. The cumulative risk for EK ranged from virtually 0 for risk scores <4 to almost 100 percent for those with a score of 8.
Scientists wrote that the combination of central corneal thickness values and tomographic features can be employed to make valid predictions of the risk of requiring endothelial keratoplasty after phacoemulsification.
SOURCE: Arnalich-Montiel F, de-Arriba-Palomero P, Muriel A, et al. A risk prediction model for endothelial keratoplasty after uncomplicated cataract surgery in Fuchs endothelial corneal dystrophy. Am J Ophthalmol 2021; May 2. [Epub ahead of print].
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Outcomes of Eyes with Intraocular Inflammation after Brolucizumab: Post Hoc Analysis of HAWK and HARRIER
This analysis of the Phase III HAWK and HARRIER trials sought to provide insights on the timing of presentation, management and outcomes of intraocular inflammation (IOI)-related adverse events (AEs), as reported by investigators in these trials.
The post hoc analysis of investigator-reported IOI-related AEs in HAWK and HARRIER included 49 eyes of 1,088 brolucizumab-treated eyes (3 mg or 6 mg) that experienced at least one IOI-related AE.
Researchers analyzed reports of IOI-related AEs and provided statistics for outcome measures. The main outcome measures included incidence and description of eyes with IOI-related AEs, timing of presentation, management, clinical outcomes and brolucizumab treatment after the first IOI-related AE.
Here were some of the findings:
• A total of 70 IOI-related AEs were reported in 49 eyes.
• Prior to the onset of first IOI-related AE, eyes received a mean of 3.9 ±2.2 brolucizumab injections.
• Median (25th to 75th percentile) time to first IOI-related AE from the last administered brolucizumab injection was 18 (four to 29) days.
• Of the 70 AEs, 61 (87.1 percent) were treated, the majority with topical corticosteroids; systemic and intraocular corticosteroids were used for three AEs each.
• Overall, inflammation resolved completely in 39 eyes (79.6 percent), resolved with sequelae in five eyes (10.2 percent), and it didn’t resolve in five eyes (10.2 percent) by the end of the study.
• Overall, mean best-corrected visual acuity change was:
o from baseline to the end of the study: -0.84 ±20.6 ETDRS letters;
o before AE to the lowest BCVA in three months after AE: -16.31 ±17.6 letters; and
o from before AE to the end of the study was -0.22 ±18.9 letters.
• Of the 36 eyes (73.5 percent) that continued on brolucizumab after the first IOI-related AE, 24 completed the trials and 12 discontinued them; the mean BCVA change in the eyes was 2.6 ±17.6, 7.8 ±13.2 and -7.7 ±21.3 letters, respectively, from baseline to the end of the study.
• The remaining 13 eyes (26.5 percent) weren’t treated with brolucizumab after the first IOI-related AE and had a mean BCVA change of -10.4 ±25.5 letters from baseline to the end of the study.
Researchers wrote that their findings highlighted the need for continued vigilance and monitoring for any signs of IOI-related events in patients receiving brolucizumab.
SOURCE: Singer M, Albini TA, Seres A, et al. Clinical characteristics and outcomes of eyes with intraocular inflammation after brolucizumab: Post hoc analysis of HAWK and HARRIER. Ophthalmol Retina 2021; May 7. [Epub ahead of print].
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Industry News
Essilor Receives FDA Breakthrough Device Designation for Stellest Lens in Myopia Efforts
Essilor announced that the FDA granted Breakthrough Device designation to its
Essilor Stellest spectacle lens, the company’s new generation lens developed to
correct myopia and slow down the progression of myopia in children. The designation comes after the publication of two-year results of an ongoing three-year clinical trial in myopic children in China. After the first year, the trial results demonstrated that the eye growth of nine out of 10 children wearing the Essilor Stellest lens was similar or slower than non-myopic children. Read more.
J&J Vision Provides Update on Copyright & Patent Infringement Claims Against Alcon
Johnson & Johnson Vision, which is litigating a large intellectual property dispute in several countries against Alcon on the basis that Alcon’s LenSx Femtosecond Laser Systems infringe on the company’s copyrighted source code as well as certain patents relating to the Catalys Precision Laser System, reported that “the court determined May 13 that J&J Vision demonstrated a likelihood of success on its copyright infringement claims and that the resultant damages may be significant.” With that, the court concluded a preliminary injunction wasn’t warranted because the harm could be remedied by monetary relief at the completion of the trial. In February, J&J Vision filed a motion for a preliminary injunction against Alcon in its U.S. case, asking the court to prevent Alcon from selling new and refurbished LenSx Femtosecond Laser System during the pendency of the suit.
New Study Identifies Number of People with Vision Loss and Blindness
In a study published in JAMA Ophthalmology titled “Prevalence of Visual Acuity Loss or Blindness in the U.S.,” researchers estimate more than 7 million people are living with uncorrectable vision loss, including more than 1 million Americans who are living with blindness. The study was authored by researchers from the Institute for Health Metrics and Evaluation at the University of Washington in Seattle, NORC at the University of Chicago and the Centers for Disease Control and Prevention’s Vision Health Initiative, with support from Prevent Blindness. Read more.
Alimera Sciences Appoints Dr. Dyer as Chief Retina Specialist
Alimera Sciences announced the appointment of David Dyer, MD, as chief retina specialist. Dr. Dyer founded Retina Associates, LLC in 1999, in addition to founding TreVia Digital Health, LLC, a health-care company that provides digital diabetic retinopathy screenings among other services, as well as iTronix Systems, LLC a medical device development company. Read more.
The Children’s Eye Foundation of AAPOS Debuts Interactive Storybook to Help Screen for Color Vision Deficiency
The Children’s Eye Foundation of AAPOS unveiled the world’s first interactive children’s book to help screen for color vision deficiency (CVD), commonly known as color blindness. The foundation has posted a free digital version of at its website and published a first-run, hardcover book for its member pediatric ophthalmologists. The organizations say that the unique book meets a significant unmet societal need, as neither schools nor most physicians’ offices screen for CVD, and children generally don't even know they have it. Visit the site.
NCCVEH at Prevent Blindness Issues Call for Nominations for Bonnie Strickland Champion for Children’s Vision Award
The National Center for Children’s Vision and Eye Health at Prevent Blindness (NCCVEH) issued the call for nominations for the seventh annual Bonnie Strickland Champion for Children’s Vision Award. The award recognizes significant efforts by an individual or group to improve public health approaches for children’s vision and eye health at the state or national level. The deadline for submission is July 10. Read more.
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