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| Vol. 23, #24 • Monday, June 20, 2022 |
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JUNE IS FIREWORKS EYE SAFETY & CATARACT AWARENESS MONTH
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Race & Ethnicity Differences in Glaucoma Severity and VF Progression
Researchers looked at associations of race and ethnicity, and preferred language with baseline glaucoma severity, VF test frequency and disease progression, in a retrospective cohort study.
Patients receiving VF testing at a tertiary eye-care center between 1998 and 2020, with self-identified race, ethnicity and preferred language were included. Outcome measures were VF MD and age at first visit, VF test frequency and VF MD progression.
Here are some of the findings:
• Among 29,891 patients with VF measurements between 1998 and 2020, 55.1 percent were female, 71 percent self-identified as white/Caucasian, 14 percent as black/African American, 7.4 percent as Asian and 6.4 percent as Hispanic and 11.2 percent preferred a language other than English.
• Mean VF MD at presentation was worse among black (-9.3 ±9.7 dB), Asian (-6.2 ±7.6 dB) and Hispanic (-8.3 ±9.3 dB) patients vs. white patients (-5.5±7.3 dB; p<0.001) or non-Hispanics (-6.2±7.8 dB; p<0.001).
• After controlling for age, gender and English proficiency, disparities in glaucoma severity at presentation were reduced, especially among Asian and Hispanic patients.
• Despite greater severity at presentation, black patients had lower VF test frequency/person-years (1.07 ±0.53) vs. white patients (1.12 ±0.52; p=0.006) and worse VF MD progression (-0.43 dB/year; CI, -0.67 to -0.28; p<0.001).
• Hispanic patients had a higher VF frequency vs. non-Hispanic patients (1.18 ±0.64 vs. 1.11±0.52, p<0.001) and no difference in VF progression (p=0.77).
Researchers found that black, Asian and Hispanic patients had greater baseline severity vs. white patients. Unlike other groups, black patients had a lower VF frequency vs. white patients and greater VF progression. Disparities in baseline severity were partially explained by English proficiency, especially for Asian and Hispanic patients.
SOURCE: Halawa OA, Jin Q, Pasquale LR, et al. Race and ethnicity differences in disease severity and visual field progression among glaucoma patients. Am J Ophthalmol 2022; May 30. [Epub ahead of print].
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Intravitreal Aflibercept for DME in Real-world Clinical Practice in Japan
Investigators assessed the safety and effectiveness of intravitreal aflibercept (IVT-AFL) for diabetic macular edema in the real-world clinical practice setting in Japan.
In this prospective, multicenter, observational, post-marketing surveillance, patients with DME newly receiving IVT-AFL were enrolled. During a 24-month follow-up, the primary outcome was the occurrence of safety events. Other pre-specified endpoints were effectiveness indicators, such as best-corrected visual acuity, central retinal thickness and injection frequency.
In total, 646 patients administered at least one IVT-AFL injection were included, with 622 patients included in the effectiveness analysis set. Here are some of the findings:
• During the follow-up period, adverse events occurred in 42 patients (6.5 percent), while adverse drug reactions occurred in 12 patients (1.86 percent).
• In the 12 patients who had adverse drug reactions, seven events occurred in seven patients within the first month of the most recent injection.
• The number of injections over 24 months was 3.6 ±3.0 (mean ± SD).
• BCVA (logMAR) was 0.437 ±0.362 (mean ±SD)(n=622) at baseline and 0.321 ±0.348 (n=177) after 24 months of treatment with IVT-AFL.
• Central retinal thickness was 440.8 ±134.2 μm (mean ±SD)(n=444) at baseline and 355.5 ±126.4 μm (n=140) at 24 months.
Investigators wrote that routine administration of IVT-AFL for DME wasn’t associated with new safety concerns, and BCVA outcomes were maintained over 24 months in the real-world setting. In spite of that, they added, patients in this real-world setting received fewer injections than those in clinical trials, suggesting that a margin for improvement exists in clinical practice.
SOURCE: Sugimoto M, Handa C, Hirano K, et al. Intravitreal aflibercept for diabetic macular edema in real-world clinical practice in Japan: 24-month outcomes. Graefes Arch Clin Exp Ophthalmol 2022; Jun 2. [Epub ahead of print].
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Complimentary CME Education Videos
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Changes in Asphericity in Myopia After Topography-guided FS-LASIK
Scientists compared changes in the asphericity of anterior and posterior corneal surfaces for different myopia patients after corneal topography-guided femtosecond-assisted LASIK (FS-LASIK). They also analyzed correlations between asphericity of corneal surfaces and preoperative spherical equivalence.
In this prospective study, 59 patients who underwent corneal topography-guided FS-LASIK surgery were enrolled and divided into a mild-to-moderate myopia group (67 eyes), and a high-myopia group (44 eyes). Postoperative follow-ups were performed at one, three and six months. Postoperative changes in aspherical coefficient (Q values), corneal higher-order aberrations and spherical aberrations (Z40) were compared between the two groups. Relevance between Q value changes and SEQ, HOAs and Z40, as well as between SEQ and changes of HOAs and Z40 was analyzed.
Here are some of the findings:
• A significant increase was found in Q values of the anterior (each diameter) and posterior (6 to 8 mm) corneal surface in both groups after surgery (p<0.001).
• Q values of corneal anterior (each diameter) and posterior (7 to 9 mm) surface in the high group were considerably larger than in the mild to moderate group (p<0.05).
• Corneal anterior surface HOAs and Z40 values in the high group largely exceeded those of the mild-moderate group (p<0.001).
• The preoperative SEQ was linearly correlated with postoperative anterior Q change (ΔQ), HOAs change (ΔHOAs) and spherical aberration change (ΔZ40).
Scientists reported that changes in corneal asphericity in patients with high myopia were greater than in mild to moderate myopia, with more corneal HOAs and Z40 introduced when corneal topography-guided FS-LASIK was conducted.
SOURCE: Wu Y, Sun S, Liu Z, et al. Changes in asphericity of anterior and posterior corneal surfaces for mild-moderate and high myopia after topography-guided FS-LASIK. Int Ophthalmol 2022; May 30. [Epub ahead of print].
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Long-term Outcomes of Adding Lutein/Zeaxanthin and ω-3 Fatty Acids to AREDS Supplements: AREDS2 Report 28
As most clinicians know, after the Age-Related Eye Disease Study 2 (AREDS2) study, the beta carotene component was replaced by lutein/zeaxanthin for the development of the revised AREDS supplement. However, the AREDS2 researchers say that, until now, we didn’t know whether the increased risk of lung cancer observed in those assigned to beta carotene persisted beyond the conclusion of the AREDS2 trial, and whether any benefit of adding lutein/zeaxanthin to the original AREDS supplement is observable in long-term follow-up.
Because of this, they looked at 10-year risk of developing lung cancer and late age-related macular degeneration. The multicenter epidemiologic follow-up study of the AREDS2 clinical trial, conducted from December 1, 2012, to December 31, 2018, included participants with bilateral or unilateral intermediate AMD for an additional five years after the clinical trial. Eyes/participants were censored at the time of late AMD development, death or loss to follow-up. Data were analyzed from November 2019 to March 2022.
During the clinical trial, participants were randomly assigned primarily to the following groups: lutein/zeaxanthin and/or ω-3 fatty acids or placebo; and secondarily to no beta carotene vs. beta carotene, and low vs. high doses of zinc. In the epidemiologic follow-up study, all participants received AREDS2 supplements with lutein/zeaxanthin, vitamins C and E, and zinc plus copper. Outcomes were assessed via six-month telephone calls. Analyses of AMD progression and lung cancer development were conducted using proportional hazards regression and logistic regression, respectively.
Main outcomes and measures included self-reported lung cancer and late AMD validated with medical records.
This study included 3,882 participants (mean [SD] baseline age, 72 [7.7] years; 2,240 women [57.7 percent]) and 6,351 eyes. Here are some of the findings:
• At 10 years, the odds ratio of having lung cancer was 1.82 (CI, 1.06 to 3.12; p=0.02) for those randomly assigned to beta carotene and 1.15 (CI, 0.79 to 1.66; p=0.46) for lutein/zeaxanthin.
• The hazard ratio for progression to late AMD comparing lutein/zeaxanthin with no lutein/zeaxanthin was 0.91 (CI, 0.84 to 0.99; p=0.02), and comparing ω-3 fatty acids with no ω-3 fatty acids was 1.01 (CI, 0.93 to 1.09; p=0.91).
• When the lutein/zeaxanthin main effects analysis was restricted to those randomly assigned to beta carotene, the HR was 0.80 (CI, 0.68 to 0.92; p=0.002).
• A direct analysis of lutein/zeaxanthin vs. beta carotene showed the HR for late AMD was 0.85 (CI, 0.73 to 0.98; p=0.02).
• The HR for low vs. high zinc was 1.04 (CI, 0.94 to 1.14; p=0.49), and the HR for no beta carotene vs. beta carotene was 1.04 (CI, 0.94 to 1.15; p=0.48).
The researchers say that findings from the long-term epidemiologic follow-up study of the AREDS2 cohort suggest that lutein/zeaxanthin is an appropriate replacement for beta carotene in AREDS2 supplements. They note that beta carotene usage nearly doubled the risk of lung cancer, while no statistically significant increased risk was found with lutein/zeaxanthin. Researchers further wrote that, when compared with beta carotene, lutein/zeaxanthin had a potential beneficial association with late AMD progression.
SOURCE: Chew EY, Clemons TE, Agrón E, et al; AREDS2 Research Group. Long-term outcomes of adding lutein/zeaxanthin and ω-3 fatty acids to the AREDS supplements on age-related macular degeneration progression: AREDS2 Report 28. JAMA Ophthalmol 2022; Jun 2. [Epub ahead of print].
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Industry News
Lensar Receives FDA Nod for Ally Adaptive Cataract Treatment System
Lensar’s FDA 510(k) clearance for its next-generation Ally Adaptive Cataract Treatment System means cataract surgeons can complete the femtosecond-laser-assisted cataract surgery procedure in a single, sterile environment, the company says. The company says it plans to deliver the first Ally Systems to surgeons in the third quarter of this year. Read more.
Contact Lens News
With the goal of providing an individualized vision-correcting solution to a broad range of patients, Bausch + Lomb announced the U.S. launch of a new family of customizable soft contact lenses, Revive. Available in spherical, toric, multifocal and multifocal toric options, Revive lenses are made with a non-ionic material that helps resist protein deposits, B+L says, allowing for up to three months of daily wear; the replacement schedule is at the discretion of the doctor. The company explains that the customizable parameters include lens diameter, base curve and power, all of which can be adjusted as needed until the optimal fit is achieved. Learn more.
In other contact news, Johnson & Johnson received FDA approval for a lens called the Acuvue Oasys Max 1-Day, but the lens won’t be available for sale in the United States until the fall. Learn more.
Adverum Presents Three-year Data on IVT Injection of ADVM-022
Adverum Biotechnologies announced new data from the OPTIC study during the Macula Society Annual Meeting in Berlin, Germany. The company says the new analyses includes three-year aflibercept protein expression and “improved anatomical outcomes” in wet AMD patients treated with ADVM-022. Read more.
EyePoint to Present 12-month Results from DAVIO Phase I Trial
EyePoint will present 12-month data from its Phase I DAVIO clinical trial evaluating its drug EYP-1901 for the treatment of wet age-related macular degeneration at the American Society of Retinal Specialists 2022 annual meeting in New York City (July 13 to 16). Read more.
Outlook Confirms BLA Submission Status for ONS-5010
Outlook Therapeutics confirmed the additional information necessary to re-submit its Biologics License Application for ONS-5010 / Lytenava (bevacizumab-vikg) for the treatment of wet age-related macular degeneration after the FDA requested additional information. Read more.
New Hires
• Dr. Anne L. Coleman, MD, PhD, UCLA Fielding School of Public Health professor of epidemiology, was named executive medical director and chair of the department of ophthalmology at the David Geffen School of Medicine at UCLA. Dr. Coleman will also serve as director of the UCLA Stein Eye Institute and affiliation chair of the Doheny Eye Institute. Read more.
• Clearside appointed Susan L. Coultas, PhD, as chief clinical officer. Most recently, Dr. Coultas served as senior vice president of clinical development at Kala Pharmaceuticals. Read more.
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