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| Vol. 23, #23 • Monday, June 13, 2022 |
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JUNE IS FIREWORKS EYE SAFETY & CATARACT AWARENESS MONTH
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Frequency of VF Testing of POAG Patients
Researchers wrote that visual field testing that isn’t frequent enough results in delayed identification of open angle glaucoma progression. Guidelines recommend at least annual testing although it isn’t known how frequently patients with OAG across the United States receive VF testing and how patient characteristics and circumstances influence this frequency, they wrote. If patients with OAG don’t receive VF tests frequently enough, interventions to increase this frequency or to develop other forms of testing visual function may reduce unidentified OAG vision loss, they wrote further.
As part of a retrospective cohort study, researchers used the TruvenHealth MarketScan Commercial Claims Database (IBM; Armonk, N.Y.), containing demographic and claims data for >160 million individuals across the United States from 2008 to 2017 to identify enrollees in the database with a recorded diagnosis of OAG (ICD-9-CM codes: 356.1x; ICD-10-CM codes: H40.1x). They excluded individuals younger than 40 at the time of their first OAG diagnosis, those without at least one confirmatory OAG diagnosis at a subsequent visit and those with <4 years of follow-up data after OAG diagnosis.
Researchers categorized the patients based on the number of VF tests that they underwent per year (0; >0 to <0.9; ≥0.9 to ≤1.1; >1.1 to ≤2.1; and >2.1). They used negative binomial regression to investigate which demographic or health variables were associated with the frequency of VF tests that enrollees with OAG received.
The main outcome measure was frequency of VF testing among enrollees with OAG.
Here are some of the findings:
• Of the 380,029 enrollees included in the study, 8.8 percent (33,267) didn’t receive a visual field test during the study period;
• 68.2 percent (259,349) underwent >0 to <0.9 VF tests per year;
• 11.1 percent (42,129) underwent ≥0.9 to ≤1.1 VF tests per year;
• 11.1 percent (42,301) underwent >1.1 to ≤2.1 VF tests per year; and
• 0.8 percent (2,983) underwent ≥2.1 VF tests per year.
• The median number of VF tests per year was 0.63 (IQR, 0.33 to 0.88; mean: 0.65).
Researchers found that more than three-quarters of enrollees with OAG received less than one visual field test per year and, thus, didn’t receive guideline-adherent glaucoma monitoring.
SOURCE: Stagg BC, Stein JD, Medeiros FA, et al. The frequency of visual field testing in a US nationwide cohort of individuals with open angle glaucoma. Ophthalmol Glaucoma 2022; May 19. [Epub ahead of print].
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Reticular Pseudodrusen: Macular Risk Feature for Late AMD Progression
Researchers analyzed reticular pseudodrusen (RPD) as an independent risk factor for progression to late age-related macular degeneration alongside traditional macular risk factors (soft drusen and pigmentary abnormalities) considered simultaneously.
The post hoc analysis of two clinical trial cohorts—the Age-Related Eye Disease Study (AREDS) and AREDS2—included eyes with no late AMD at baseline in AREDS (n=6959 eyes, 3780 participants; mean age 69.4 years) and AREDS2 (n=3355 eyes, 2056 participants; mean age 72.3 years).
Researchers graded color fundus photographs (CFP) from annual study visits for soft drusen, pigmentary abnormalities and late AMD. They determined RPD presence by grading of fundus autofluorescence images (AREDS2) and deep learning grading of CFP (AREDS). And they performed proportional hazards regression analyses, considering AREDS AMD severity scales (modified simplified severity scale [person] and nine-step scale [eye]) and RPD presence simultaneously.
Main outcome measures included progression to late AMD, geographic atrophy and neovascular AMD (NV).
Here are some of the findings:
• In AREDS, in late AMD analyses by person in a model considering the modified simplified severity scale simultaneously, RPD presence was associated with higher risk of progression: HR: 2.15; CI, 1.75 to 2.64.
• The risk associated with RPD presence differed significantly at different simplified severity scale levels, at levels 0, to one through four, respectively:
o HR: 3.23; CI, 1.60 to 6.51;
o HR: 3.81; CI, 2.38 to 6.10;
o HR: 2.28; CI, 1.59 to 3.27; and
o HR: 1.64; CI, 1.20 to 2.24.
• Considering the nine-step scale (by eye), RPD presence was also associated with higher risk: HR: 2.54; CI, 2.07 to 3.13.
• HRs were 5.11; CI, 3.93 to 6.66 at levels one to six, and 1.78; CI, 1.43 to 2.22 at levels seven to eight.
• In AREDS2, by person, RPD presence wasn’t associated with higher risk:
o HR: 1.18; CI, 0.90 to 1.56;
o by eye: HR: 1.57; CI, 1.31 to 1.89.
• No significant differences in risk were observed at different severity levels for the limited spectrum in AREDS2.
• In both cohorts, RPD presence carried higher risk for GA than NV.
Researchers wrote that RPD represented an important anatomical risk factor for progression to late AMD, particularly GA. However, they noted that the added risk associated with RPD varied markedly by severity level; it carried highly increased risk at lower/moderate levels and less increased risk at higher levels. They suggested that RPD status should be included in updated AMD classification systems, risk calculators and clinical trials.
SOURCE: Agrón E, Domalpally A, Cukras CA, et al; AREDS and AREDS2 Research Groups. Reticular pseudodrusen: The third macular risk feature for progression to late age-related macular degeneration. Ophthalmology 2022; May 31. [Epub ahead of print].
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Complimentary CME Education Videos
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Refractive Stability, Axial Elongation & Related Factors in a High Myopia Population After ICL Implantation
Scientists evaluated the refractive stability, axial length (AL) changes and related factors in a high myopia population after implantable collamer lens (Visian ICL, Staar) implantation.
This prospective study included 116 eyes of 116 patients divided into several groups based on the spherical equivalent (SE) refractive error:
• SE ≥6 D; -12 ≤SE ≤6 D; and SE ≤12 D
• AL <28 mm; and AL ≥28 mm.
The uncorrected and corrected distance visual acuity, refraction, AL and intraocular pressure were followed for one year.
Here are some of the findings:
• SE changed from -11.53 ±5.25 D preoperatively to -0.33 ±0.70 D at one week, and further changed to -0.48 ±0.77 D at one year after ICL implantation, with average progression being -0.15 ±0.37 D from one week to one year after surgery.
• AL changed from 27.95 ±2.33 mm preoperatively to 27.98 ±2.36 mm one year after surgery, with an average axial elongation of 0.03 ±0.12 mm.
• The mean axial elongation rate was 0.05 mm/year in the SE ≤12 D group, which was significantly faster than the other refractive groups (p<0.05).
• The mean axial elongation rate was 0.06 mm/year in the AL ≥28 mm group, which was significantly faster than the AL <28 mm group (p<0.05).
Scientists found that patients with high myopia and long AL showed a continuous myopic progression and axial elongation at an adult age one year after ICL surgery, especially in those with myopia higher than -12 D and AL longer than 28 mm.
SOURCE: Chen X, Chen Z, Miao H, et al. One-year analysis of the refractive stability, axial elongation and related factors in a high myopia population after implantable collamer lens implantation. Int Ophthalmol 2022; May 19. [Epub ahead of print].
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Baseline Sattler Layer Choriocapillaris Complex Thickness Cutoffs & AMD Progression
Researchers looked at the relationship between choroidal overall and sublayer thickness and AMD stage progression, as part of a prospective, observational case series.
A total of 262 eyes of 262 patients with different stages of AMD were imaged by optical coherence tomography. AMD stage, choroidal thickness (CT), Sattler layer-choriocapillaris complex thickness (SLCCT) and Haller layer thickness (HLT) were determined at the baseline visit, at one-year follow-up, at two-year follow up and at a final visit (performed after a mean of 5 ±1 years from the baseline visit).
Here are some of the findings:
• Baseline AMD stages were distributed as follows:
o early AMD: 30 eyes (12 percent);
o intermediate AMD: 97 eyes (39 percent); and
o late AMD: 126 eyes (49 percent).
• At the final follow-up, AMD stages were so distributed:
o early AMD: 14 eyes (6 percent];
o intermediate AMD: 83 eyes (33 percent); and
o late AMD: 156 eyes (61 percent).
• Each group showed a statistically significant decrease in CT values over the entire follow-up period (p<0.001), and SLCCT reduction was associated with AMD progression (p<0.001).
• SLCCT quantitative cutoffs <20.50 µm and <10.5 µm were associated with a moderate and high probability of AMD progression, respectively, and SLCCT quantitative cutoffs <18.50 µm and <8.50 µm correlated with a moderate and high probability of macular neovascularization onset, respectively.
Researchers wrote that progressive choroidal impairment contributed to AMD progression. They added that among choroidal layers, a reduced SLCCT was a promising biomarker of disease worsening, and its quantitative evaluation could help identify patients at higher risk of advancement.
SOURCE: Amato A, Arrigo A, Borghesan F, et al. Baseline Sattler layer-choriocapillaris complex thickness cutoffs associated with age-related macular degeneration progression. Retina 2022; May 12. [Epub ahead of print].
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Industry News
Outlook Provides Update on BLA Submission for ONS-5010
Outlook Therapeutics announced the FDA requested additional information in order to complete the filing of the company’s Biologics License Application for ONS-5010/ Lytenava (bevacizumab-vikg) for the treatment of wet age-related macular degeneration. Outlook has voluntarily withdrawn its BLA for ONS-5010 and is actively working to respond to the FDA’s request and re-submit a revised BLA by September. Learn more.
Macular Society Presentations
At the Macula Society’s 2022 annual meeting June 8 to 11, in Berlin, Germany, the following companies announced these presentations:
• Adverum Biotechnologies offered new data from the Phase I OPTIC study ADVM-022 (AAV.7m8-aflibercept) development program in wet AMD, including an update on aflibercept protein expression data through three years post-treatment. A new analysis compared the anatomical outcomes of a single intravitreal injection of ADVM-022 to standard-of-care bolus anti-vascular endothelial growth factor therapy in patients with wet AMD. Learn more.
• Ocuphire presented new interim masked safety data for oral apx3330 in diabetics. Learn more.
CDC Study: Vision Impairment Trends Among Adults with Diabetes
A Centers for Disease Control and Prevention study reveals that declines in vision impairment among diabetic adults seen in the first decade of the 2000s may have plateaued in 2012. A previous study examining the period from 1997 to 2010 found a decline in self-reported vision impairment prevalence among adults with diabetes. Learn more.
New Appointments
• Nacuity Pharmaceuticals expanded its scientific advisory board with appointment of Nancy Holekamp, MD, and Richard L. Lindstrom, MD. Read more.
• Ocular Therapeutix announced that Peter K. Kaiser, MD, will advise the company in a newly created role of chief medical advisor for retina; Rabia Gurses Ozden, MD, senior vice president, clinical development, was promoted to the role of chief medical officer; and Michael Goldstein, MD, chief medical officer, president of ophthalmology, who will depart from the company June 30, will continue on part-time as a consultant in a newly created role of chief strategy advisor. Read more.
· Aurion Biotech appointed Michael Goldstein, MD, MBA, as president and chief medical officer. Read more.
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