From the editors of Review of Ophthalmology:
AUGUST IS CHILDREN’S EYE HEALTH AND SAFETY MONTH
In this issue: (click heading to view article)
“Ultra-Response” to Ranibizumab Found in Genentech Study
In a Genentech-sponsored study, researchers aimed to quantify and evaluate individuals with diabetic retinopathy who had at least four-step improvements on the Early Treatment Diabetic Retinopathy Study Diabetic Retinopathy Severity Scale in response to ranibizumab treatment in post hoc study of the results of the Diabetic Retinopathy Clinical Research Network Protocol S study.
The retrospective analysis of two-year outcomes in the Phase III Protocol S study included individuals randomized to treatment with ranibizumab 0.5 mg with sufficient baseline DRSS severity (≥47) to allow for an at least four-step improvement (n=181).
Study eyes received a ranibizumab 0.5 mg injection at baseline and every four weeks for 12 weeks, with subsequent as-needed injections. Fundus photographs graded at baseline and years one and two using DRSS were used for this analysis. (Researchers clarified that the data source was DRCR.net, but analyses, content and conclusions of this report are solely the responsibility of the authors.)
Main outcome measures included the proportion of eyes achieving at least a four-step DRSS improvement (DR ultra-response) at years one and two; treatment course for eyes achieving ultra-response; mean change in best-corrected visual acuity in eyes with and without ultra-response; and factors associated with ultra-response (identified by univariate and multivariable analyses).
Here were some of the findings:
- Nearly 30 percent of ranibizumab-treated eyes achieved DR ultra-response at year one (43/148; 29.1 percent) and year two (38/136; 27.9 percent).
- Seventy-four percent of eyes with ultra-response at year one maintained their response at year two.
- At year two, individuals with DR ultra-response had gained more than five additional ETDRS letters compared with those without DR ultra-response.
- Multivariable analyses identified presence of vitreous hemorrhage at baseline, increasing age, absence of epiretinal membrane and glycated hemoglobin below nine as predictive of DR ultra-response.
- Mean number of injections received was similar for eyes with vs. without DR ultra-response to ranibizumab (mean: 7.4 vs. 7.6 in year one; mean: 4.2 vs. 3.9 in year two, respectively).
Researchers concluded that approximately 30 percent of eyes with a DRSS score of at least 47 receiving ranibizumab 0.5 mg per study protocol experienced at least four-step DR severity improvement on the DRSS, accompanied by meaningful improvements in BCVA.
SOURCE: Chiang A, Garg SJ, Klufas MA, et al. Ultra-response to ranibizumab: Improvement by 4 or more steps in diabetic retinopathy severity in DRCR.net Protocol S. Ophthalmol Retina 2020; July 28. [Epub ahead of print].
Complimentary CME Education Videos
Heads-up DMEK Surgery
Investigators assessed the feasibility of Descemet’s membrane endothelial keratoplasty surgery using the glasses-assisted 3-D display system Ngenuity (Alcon) and compared it with standard DMEK surgery by using a conventional operating microscope.
Twelve consecutive cases of DMEK surgery were performed using the glasses-assisted 3-D display system Ngenuity and matched with similar cases performed by using the OPMI-Lumera 700 surgical microscope (Carl Zeiss Meditec) in this prospective, cross-sectional study performed at the Rothschild Foundation in Paris. DMEK graft preparation time, graft unfolding time, time to perform the descemetorhexis and overall surgical time were recorded. Best-corrected visual acuity, endothelial cell density of the donor tissue measured by specular microscopy and the recipient's central corneal thickness were recorded preoperatively, and at one and three months postoperatively.
Here were some of the findings:
- In the 3-D group, time to perform the graft preparation, DM and global surgical time was significantly higher in the 3-D group than in the conventional group, respectively (in min:sec):
- 17:36 ±3:13 vs. 14:50 ±1:28; p=0.04;
- 6:18 ±2:30 vs. 3:50 ±2:8; p=0.03; and
- 31:30 ±6:10 vs. 24:10 ±3:26; p=0.05.
- The time to unfold the graft was higher, although not significantly so, in the 3-D group compared with the conventional group, respectively: 5:15 ±2:40 vs. 4:40 ±2:25; p=0.89.
- Mean central corneal thickness decreased about 168 ±82 μm at three months after surgery in the 3-D group and about 228 ±123 μm in the conventional group without significant difference (p=0.60).
- Best-corrected visual acuity in the 3-D group was 0.33 ±0.32 logMAR at three months after surgery with no significant differences found when compared with conventional surgery.
- The percent endothelial cell loss from preoperative, at three months was: 35 percent in the 3-D group and 26 percent in the conventional group, with no significant difference (p>0.05).
Investigators reported that performing DMEK surgery using a 3-D display system was feasible; however, they added that it was more challenging, and the total surgical time was longer. They noted that the method would be useful for instructional courses.
SOURCE: Panthier C, Courtin R, Moran S, et al. Heads-up Descemet membrane endothelial keratoplasty surgery: Feasibility, surgical duration, complication rates, and comparison with a conventional microscope. Cornea 2020; July 2. [Epub ahead of print].
Complimentary CME Education Videos
Natural History of Quantitative Autofluorescence in Intermediate AMD
Scientists evaluated differences in quantitative autofluorescence (qAF) imaging measurements between eyes with and without large drusen, and whether qAF measurements changed over time in eyes with large drusen.
A total of 85 eyes from participants with bilateral large drusen, and 51 eyes from healthy participants underwent qAF imaging at least once. Age-related macular degeneration participants were reviewed monthly for six months. Normalized gray values at 9- to 11-degree eccentricity from the fovea were averaged to provide a summary measure of qAF values (termed “qAF8”).
In a multivariable model, qAF8 measurements weren’t significantly different between AMD eyes with large drusen and healthy eyes (p=0.130), and qAF8 measurements showed a decline over time in AMD eyes (p=0.013).
Scientists wrote that qAF levels weren’t increased in eyes with large drusen compared with healthy eyes, and that qAF levels showed a significant decline over time in the AMD eyes. In addition, they wrote, the findings highlight how the relationship between qAF levels and retinal pigment epithelium health doesn’t appear to be straightforward and that further investigation is required to better understand this relationship, especially if qAF levels may be used as an outcome measure in intervention trials.
SOURCE: Emde LV, Guymer RH, Pfau M, et al. Natural history of quantitative autofluorescence in intermediate age-related macular degeneration. Retina 2020; Jul 22. [Epub ahead of print].
Correlation of Retinal Thickness Measures & ONH Parameters Between OCT Scan Types
Retinal imaging devices on the market can produce optical coherence tomography scan patterns with different fields of view and resolution to depict different regions of the retina. Researchers wrote that it’s important that quantitative measures of the same structure, such as macular and peripapillary thickness values or optic nerve head parameters, remain consistent regardless of the scan pattern that they are measured from. They retrospectively analyzed the correlation between retinal measures obtained by automated processing of three different types of OCT scans. Several of the study's authors are employees for Optos, maker of the device used in the study.
Researchers acquired retinal (9 mm x 9 mm, fovea-centered), ONH (6 mm x 6 mm, ONH-centered) and raster (14 mm x 9 mm, macular and ONH regions) scans from a new multi-mode imaging device that combines ultra-widefield imaging and swept-source OCT (Silverstone, Optos). In total, 19 retina/raster and 31 ONH/raster scan pairs were available from a population of healthy and diseased eyes (AMD, DR and macula hole).
Researchers used a deep learning model for layer segmentation. They automatically derived and analyzed total retina thickness (TRT); nerve fiber layer (NFL) and ganglion cell complex (GCC) macular values; four quadrants of peripapillary NFL thickness and three ONH parameters (disc, cup and neuroretinal rim areas). Researchers calculated Pearson’s correlation coefficients for corresponding pairs of measures and applied Bonferroni correction for multiple testing to assess statistical significance.
Here were some of the findings:
- Significant correlation was found between all 10 investigated measures.
- Values were especially high for macular thickness (all three [TRT, NFL, GCC] above 0.95).
- Values were especially high for TRT in all nine ETDRS subfields (984, 0.983, 0.989, 0.988, 0.987, 0.885, 0.988, 0.955 and 0.976).
Researchers concluded that measurements among the same retinal structures were consistent between scan patterns. They noted that this finding is important clinically as it shows that patients can be followed accurately if scan patterns change over time. They also suggested that a single raster could be used in place of separately captured retina and ONH scans.
SOURCE: Pellegrini E, Fleming A, Sinai M, et al. Correlation of retinal thickness measures and optic nerve head parameters between different OCT scan types Invest Ophthalmol Vis Sci 2020;61(9):PB00102.
Eyenuk Announces FDA Clearance for EyeArt
Eyenuk received FDA 510(k) clearance to market its EyeArt autonomous AI System for diabetic retinopathy. EyeArt is indicated to automatically detect more than mild diabetic retinopathy (mtmDR) and vision-threatening diabetic retinopathy (vtDR) in eyes of adults diagnosed with diabetes who haven’t been previously diagnosed with more than mild diabetic retinopathy. Read more.
EyePoint & Harrow Health’s ImprimisRx Announce DEXYCU Alliance
EyePoint Pharmaceuticals and ImprimisRx announced the signing of a commercial alliance for the joint promotion of Dexycu (dexamethasone intraocular suspension) 9% for the treatment of postoperative inflammation following ocular surgery in the United States. Read more.
Bausch Health Announces Its Intention to Spin Off Its Eye Health Business
Bausch Health announced that it intends to spin off its eye-care business into an independent publicly traded entity called “Bausch + Lomb – NewCo.” The spinoff will establish two separate companies: the eye-care company; and a diversified pharmaceutical company with leading interests in gastroenterology, aesthetics/dermatology, neurology and international pharmaceuticals.
New Astigmatism Parameters for Biotrue ONEday Lens
Bausch + Lomb says there is now a -2.75 D astigmatism correction offering for its Biotrue ONEday for Astigmatism daily disposable contact lens. The company says this new parameter will be available for same-day fitting in a standard fit set. Read more.
Results from the Phase II Genentech AVENUE and STAIRWAY Studies
Genentech says Phase II studies have shown that many nAMD patients receiving faricimab, a bispecific antibody that targets Angiopoietin-2 (Ang-2) and VEGF, were able to go up to 16 weeks between treatments while achieving comparable vision improvements to monthly ranibizumab therapy. The results of the studies were recently published online in JAMA Ophthalmology. Faricimab is currently in Phase III studies for both nAMD and diabetic macular edema. Read more.
REGENXBIO Provides Phase I/IIa Trial Updates
RegenxBio reported positive one-year data from patients in cohorts four and five of the Phase I/IIa trial of RGX-314 for the treatment of wet age-related macular degeneration. The company plans to initiate a program for subretinal delivery of RGX-314 in individuals with wet AMD by the end of 2020. In addition, RegenxBio announced a Phase II trial of RGX-314 for the treatment of wet AMD delivered to the suprachoroidal space (AAVIATE) is active and expected to enroll patients in the third quarter of 2020. Read more.
Graybug Appoints Experts to Scientific Advisory Board
Graybug Vision appointed ophthalmologists and retinal experts to provide scientific counsel on the company's research and development programs. The members of the Scientific Advisory Board are: David S. Boyer, MD; Frederick L. Ferris III, MD; Jeffrey Heier, MD; Arshad M. Khanani, MD, MA; Carl D. Regillo, MD, FACS; and Rishi P. Singh, MD.
Leo Lens Pharma Expands Scientific Advisory Board
Leo Lens Pharma expanded its Scientific Advisory Board with four eye care practitioners who are highly experienced in the glaucoma field. The members of the Scientific Advisory Board are: Constance Okeke, MD, MSCE; Houman Hemmati, MD, PhD; Ian Benjamin Gaddie, OD, FAAO; Ann Giaconi, MD; Mark Dunbar, OD, FAAO; Robert Davis, OD, FAAO; and Walter Whitley, OD, MBA, FAAO.
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