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| Vol. 20, #51 • Monday, December 7, 2020 |
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DECEMBER IS SAFE TOYS AND CELEBRATIONS MONTH
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Efficacy and Safety of a Proposed Ranibizumab Biosimilar Product
Researchers wrote that the availability of a ranibizumab biosimilar product from Samsung Bioepis (Incheon, Republic of Korea), SB11, may facilitate access to an alternative treatment for neovascular age-related macular degeneration. They aimed to demonstrate the efficacy, similar safety and similar immunogenicity of SB11 compared with the reference ranibizumab. Planning, conduct, and analysis of the study was funded by Samsung Bioepis. Employees of Samsung Bioepis were involved in the study design and were coauthors.
The randomized, double-masked, parallel-group, Phase III equivalence study was conducted in 75 centers in nine countries from March 14, 2018, to December 9, 2019, among 705 participants 50 years or older with neovascular age-related macular degeneration with active subfoveal choroidal neovascularization lesions. Analysis was performed on an intent-to-treat basis. Participants received intravitreous injection of SB11 or ranibizumab 0.5 mg every four weeks through week 48.
Main outcomes and measures included:
• at week eight, the change from baseline in best-corrected visual acuity,
• at week four, the measurement of central subfield thickness, with predefined equivalence margins for adjusted treatment differences of a loss or gain of three letters of BCVA, and a change of +/- 36 μm of CST.
Here were some of the findings:
• Baseline and disease characteristics among 705 randomized participants (403 women [57.2 percent]; mean age: 74.1 ±8.5 years) were comparable between treatment groups (SB11, n: 351; ranibizumab, n: 354).
• Least-squares mean (SE) changes in BCVA from baseline at week eight were 6.2 (0.5) letters in the SB11 group vs. 7 (0.5) letters in the ranibizumab group, with an adjusted treatment difference of -0.8 letter (90 percent CI, -1.8 to 0.2 letters).
• Least-squares mean (SE) changes in CST from baseline at week four were -108 (5) μm in the SB11 group vs. -100 (5) μm in the ranibizumab group, with an adjusted treatment difference of -8 μm (CI, -19 to 3 μm).
• Incidences of treatment-emergent adverse events (231 of 350 [66 percent] vs. 237 of 354 [66.9 percent]), including serious treatment-emergent adverse events (44 of 350 [12.6 percent] vs. 44 of 354 [12.4 percent]) and treatment-emergent adverse events leading to study drug discontinuation (eight of 350 [2.3 percent] vs. five of 354 [1.4 percent]), were similar in the SB11 and ranibizumab groups.
• Immunogenicity was low, with a cumulative incidence of antidrug antibodies up to week 24 of 3 percent (10 of 330) in the SB11 group and 3.1 percent (10 of 327) in the ranibizumab group.
Researchers wrote that findings showed equivalent efficacy and similar safety and immunogenicity profiles for SB11 and ranibizumab.
SOURCE: Woo SJ, Veith M, Hamouz J, et al. Efficacy and safety of a proposed ranibizumab biosimilar product vs a reference ranibizumab product for patients with neovascular age-related macular degeneration: A randomized clinical trial. JAMA Ophthalmol 2020; Nov 19. [Epub ahead of print].
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MRI to Assess Blood Flow Rate in NTG
Investigators examined the feasibility of phase‐contrast magnetic resonance imaging (PCMRI) to assess blood flow rate in the ophthalmic artery (OA) in patients with normal-tension glaucoma (NTG) compared with healthy controls.
Sixteen individuals with treated NTG, and 16 age‐ and sex‐matched healthy controls underwent PCMRI using a 3‐Tesla scanner and ophthalmological exams. OA blood flow rate was measured using a 2D PCMRI sequence with a spatial resolution of 0.35 mm2.
Here were some of the findings:
• The average blood flow rate in the NTG group was 9.6 ±3.9 ml/min compared with 11.9 ±4.8 ml/min in the control group.
• In the NTG group, the resistance index (RI) was 0.73 ±0.08 and the pulsatility index (PI) was 1.36 ±0.29.
• In the healthy group, the RI was 0.68 ±0.13 and the PI was 1.22 ±0.40.
• The mean visual field index (VFI) was 46 percent ±25 for the worse NTG eyes.
• The measured differences observed between the NTG group and the control group in: blood flow rate (p=0.12); RI (p=0.18); and PI (p=0.27) were non‐significant.
Investigators wrote that the case-control study using PCMRI showed a slight, but non‐significant, reduction in OA blood flow rate in the NTG patients compared with the healthy controls, indicating that blood flow may be of importance in the pathogenesis of NTG. They added that a larger study or more advanced PCMRI technique might offer more conclusive information, considering that only a limited portion of the total OA blood flow supplies the ocular system and the large inter‐individual differences.
SOURCE: Kristiansen M, Lindén C, Qvarlander S, et al. Feasibility of MRI to assess differences in ophthalmic artery blood flow rate in normal tension glaucoma and healthy controls. Acta Ophthalmol 2020; Nov 19. [Epub ahead of print].
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Effects of Glycemic Variability on DR Progression in Type 2 Diabetes
Scientists evaluated the effects of glycemic variability on the progression of diabetic retinopathy in individuals with type 2 diabetes and tested the hypothesis that consistent glycemic control delays the progression of DR.
This retrospective study included 1,125 participants with a follow-up period of more than five years and more than 20 glucose laboratory test results. The hazard ratio of ≥3 steps of progression on the Early Treatment Diabetic Retinopathy Study person scale and progression to proliferative diabetic retinopathy were assessed.
An increase in the HbA1c standard deviation was associated with a higher risk of ≥3 step progression (p<0.001) as well as progression to PDR (p<0.001). Mean HbA1c and HbA1c standard deviation were associated with a lower risk of ≥3 steps of progression (p<0.001), as well as progression to PDR (p<0.001).
Scientists wrote that achievable and consistent glycemic control may contribute to the delay in DR progression.
SOURCE: Park JY, Hwang JH, Kang MJ, et al. Effects of glycemic variability on the progression of diabetic retinopathy among patients with type 2 diabetes. Retina 2020; Nov 23. [Epub ahead of print].
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Complimentary CME Education Videos
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Impact of Ocular Biometrics Measures on Myopia Onset
Researchers investigated the relationship between ocular biometrics (OB) and myopia onset using OB data from students in four grades (ages 6 to 14 years) in China in a 1.5-year longitudinal study. Refractive error was assessed with cycloplegic autorefraction.
At baseline, 934 (56.33 percent) of the subjects (the right eye of each was studied) had myopia.
Here were some of the findings:
• The mean spherical equivalent (SE) and axial length to corneal radius (AL/CR) were:
o - 2.14 ±1.49 and 3.14 ±0.11, respectively, in subjects with myopia; and
o - 0.09 ±0.21 and 2.98 ±0.07, respectively, in subjects without myopia.
• The correlation between the SE and AL/CR was r=- 0.823 (p<0.001).
• The slopes of SE changing with AL/CR (and R-squares) were:
o - 0.28 to -1.80 (0.01 to 0.14) in the non-myopia group;
o - 3.40 to -6.20 (0.20 to 0.48) in the low-myopia group; and
o - 3.37 to -11.34 (0.16 to 0.74) in the moderate- and high-myopia groups.
• The baseline AL/CR values in grades one, three and five were higher in those who developed myopia within 1.5 years.
• The odds ratio of the AL/CR to myopia onset in 1.5 years was 1.096 (CI, 1.060 to 1.135).
Researchers found, of five indicators, AL/CR showed the best correlation with SE; the adjoint and linear relationship between AL/CR and SE tended to increase with SE progression. When myopia progressed beyond a certain range, AL/CR was significantly different in those without initial myopia who developed it within 1.5 years compared with those who didn’t. After adjusting for age, sex, school and grade, researchers wrote that the interpretation capability of AL/CR to myopia onset in 1.5 years was limited.
SOURCE: Tao Z, Deng H, Zhong H, et al. A longitudinal study of the effect of ocular biometrics measures on myopia onset. Graefes Arch Clin Exp Ophthalmol 2020; Nov 17. [Epub ahead of print].
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Industry News
Survey Finds Lack of Awareness About Cataracts and Modern Treatment Options
Johnson & Johnson Vision announced findings from a global survey assessing awareness of cataracts among adults revealing a significant lack of understanding of treatment options, including surgical procedures, to correct vision loss from cataracts. Seventy percent of respondents reportedly were familiar with cataracts, and 85 percent were aware that surgery was the most common treatment option. However, among those diagnosed or with symptoms of cataracts, only 30 percent of Americans surveyed said they would be very likely to undergo cataract surgery. The most cited reason for not wanting to undergo cataract surgery was fear.
Read more.
Bausch Health Initiates Second Phase III Study for NOV03
Bausch Health Companies and Bausch + Lomb initiated the second of two Phase III studies evaluating the investigational treatment NOV03 (perfluorohexyloctane) as a first-in-class investigational drug with a novel mechanism of action to treat the signs and symptoms of dry-eye disease associated with meibomian gland dysfunction. Read more.
Study: Custom Extraction of Macular GCIPL Thickness More Precisely Co-Localizes Structural VF Measurements
A group of Australian researchers found that a custom algorithm to automatically extract optical coherence tomography-derived ganglion cell-inner plexiform layer (GCIPL) thickness measurements over retinal locations could improve future comparisons of structure and function. In their study in Scientific Reports, the algorithm automatically extracted GCIPL thickness measurements from locations corresponding to Humphrey Field Analyzer 10-2 and 30-2 test grids over Goldmann II, III and V stimulus sizes from a healthy cohort of 478 participants. Significant differences between the VF-based paradigms and the 8 × 8 grid were observed at up to 55 percent of locations across the macula, with the greatest deviations at the fovea (median 25.5 μm, CI, 25.24 to 25.72 μm, p<0.0001). Read more.
Personnel News
Several companies announced recent hires or appointments:
• Charles Reisman joined Heidelberg Engineering’s global management team as scientific director. In the newly created role, Mr. Reisman will be responsible for the clinical research plan that directly feeds into the product development pipeline.
Read more.
• Oculus announced that William Tullo, OD, FAAO, joined its team as a medical director in November. In this newly developed role, Dr. Tullo will provide clinical guidance and educate medical eye professionals on Oculus diagnostic devices.
• Tarsus Pharmaceuticals appointed veteran pharmaceutical executive Wendy L. Yarno to its board of directors and its audit committee. Read more.
Federal Court Enters Preliminary Injunction Against Myco and Choate
BlephEx announced a victory in its patent infringement lawsuit against Myco and John Choate concerning Myco’s AB Max device. Recently, the U.S. District Court for the Eastern District of Michigan granted BlephEx’s motion for a preliminary injunction against Myco and Mr. Choate. The court entered a preliminary injunction prohibiting both from “selling, distributing, offering to sell or distributing to customers in the United States” the ABMax and/or its swabs until a final judgment is entered in the suit.
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