From the editors of Review of Ophthalmology:
APRIL IS SPORTS EYE SAFETY MONTH
In this issue: (click heading to view article)
Kahook Dual Blade Excisional Goniotomy & Goniosynechialysis Combined with Phaco for ACG
Researchers characterized reductions in intraocular pressure and the need for IOP-lowering medications following phacoemulsification combined with Kahook Dual Blade-assisted goniosynechialysis and excisional goniotomy in eyes with angle-closure glaucoma and cataract.
In this retrospective, interventional case series, preoperative, operative and postoperative data were collected through six months of follow-up from 42 eyes of 24 subjects. Outcomes included: mean IOP reduction; reduction in IOP-lowering medications; and the proportion of patients achieving IOP reduction ≥20 percent, IOP ≤18 mmHg and reduction of ≥1 medication.
Preoperatively, mean IOP was 25.5 ±0.7 mmHg and the mean number of IOP-lowering medications used was 2.3 ±0.1 per eye. Here are some of the findings:
• Through six months of follow-up, researchers found mean IOP reductions of 10.1 to 12.8 mmHg (38.4 to 49.5 percent; p<
0.0001) and mean IOP medication reductions of -2.2 to -2.3 (91.7 to 98.4 percent; p<
• At month six: 92.9 percent of eyes (39/42) achieved IOP ≤18 mmHg; 100 percent (42/42) achieved IOP reduction of ≥20 percent; 100 percent (42/42) required ≥1 fewer medications for IOP control; and 85.7 percent (36/42) were medication-free.
Researchers determined that phacoemulsification combined with KDB-assisted goniosynechialysis and excisional goniotomy safely provided statistically and clinically meaningful reductions in IOP and the need for IOP-lowering medications in eyes with angle-closure glaucoma.
SOURCE: Dorairaj S, Tam MD, et al. Kahook dual blade excisional goniotomy and goniosynechialysis combined with phacoemulsification for angle closure glaucoma: 6-month results. J Glaucoma 2019; Apr 3. [Epub ahead of print].
Association of RVO with Cardiovascular Events and Mortality
Investigators wrote that previous studies examining the association of retinal vein occlusion and cardiovascular events have been inconsistent and have mostly focused on stroke and myocardial infarction. The goal of this study was to use a meta-analysis to examine the available evidence examining the association of RVO with incident cardiovascular events and mortality.
A systematic review and meta-analysis included all longitudinal cohort studies published in PubMed, Embase and the Cochrane Library from inception to April 7, 2018, that: evaluated the association of baseline RVO and incident cardiovascular events and/or mortality; provided multivariate-adjusted risk estimates with 95% confidence intervals; and that had average follow-up ≥1 year. Investigators used the Newcastle-Ottawa scale to assess study quality. Multivariate-adjusted risk estimates with 95% CI along with study characteristics were extracted from each study, and pooled risk ratios (RRs) with 95% CI were generated using a random-effects model with inverse-variance weighting to account for heterogeneity.
Main outcomes were incident stroke (fatal or nonfatal), myocardial infarction, heart failure, peripheral arterial disease, all-cause mortality and cardiovascular mortality. Fifteen cohort studies with a total of 474,466 individuals (60,069 with RVO and 414,397 without RVO) were included. Here were some of the findings:
• Each study had Newcastle-Ottawa scale score ≥6, indicating moderate-to-high quality.
• Retinal vein occlusion was associated with: increased risk of stroke (RR=1.45; CI, 1.31 to 1.60); myocardial infarction (RR=1.26; CI, 1.17 to 1.37); heart failure (RR=1.53; CI, 1.22 to 1.92); peripheral arterial disease (RR=1.26; CI, 1.09 to 1.46); and all-cause mortality (RR=1.36; CI, 1.02 to 1.81), but was not associated with increased risk of cardiovascular mortality (RR=1.78; CI, 0.70 to 4.48).
Investigators found that individuals with RVO had an increased risk of cardiovascular events and all-cause mortality. They wrote that more studies would be needed to determine the highest risk periods for cardiovascular events and mortality after RVO, and whether immediate cardiovascular evaluation and intervention would improve outcomes.
SOURCE: Wu CY, Riangwiwat T, Limpruttidham N, et al. Association of retinal vein occlusion with cardiovascular events and mortality: A systematic review and meta-analysis. Retina 2019; Feb 28. [Epub ahead of print].
Corneal Tomography Changes and Refractive Outcomes After DWEK
Scientists evaluated corneal tomography changes and refractive outcomes after Descemetorhexis without endothelial keratoplasty, as part of a retrospective chart review of 25 eyes from 16 individuals with Fuchs’ corneal endothelial dystrophy that underwent successful DWEK combined with cataract surgery.
Scientists found no significant change in anterior corneal curvature on tomography maps. However, all tomography maps demonstrated an increase in central posterior float and all but one demonstrated a decrease in pachymetry after DWEK. Here were some other findings:
• Only seven of 25 eyes had increased irregular astigmatism on tomography after DWEK, of which 57 percent had preexisting irregular astigmatism before the procedure.
• The mean difference between the targeted and outcome refraction was +0.65 D at the time of corneal clearance, but this improved to +0.38 D one month after corneal clearance.
• Postoperative refraction was within 1 D of target refraction for 92 percent of cases (23 eyes) but within 0.5 D of target refraction for 48 percent of cases (12 eyes).
• The differences between expected and actual refractive outcomes were correlated with change in posterior corneal curvature and pachymetry.
Scientists determined that DWEK induced an increased central posterior float localized to the site of Descemet’s membrane stripping, confirming the need for centralized stripping. They added that irregular astigmatism could occur after DWEK but was typically minimal and occurred more commonly in the setting of preoperative irregular astigmatism. Scientists wrote further that DWEK induced about a 0.5 D hyperopic shift, which should be considered when determining intraocular lens power with simultaneous surgery.
SOURCE: Davies E, Pineda R 2nd. Corneal tomography changes and refractive outcomes after Descemet’s stripping without endothelial keratoplasty.
Cornea 2019; Apr 16. [Epub ahead of print].
Correlation of Retinal Vascular Perfusion Density with Dark Adaptation in DR
Researchers evaluated the anatomic vs. functional changes in diabetic retinopathy by studying the correlation of retinal vascular perfusion density and dark adaptation.
They performed optical coherence tomography angiography and DA tests in diabetic patients and nondiabetic controls. They also measured DA using the AdaptDx dark adaptometer and recorded the rod intercept (the time for a participant's visual sensitivity to recover after a stimulus of a certain intensity). And they acquired macular OCTA images using the RTVue XR Avanti with AngioVue.
Researchers recruited 86 eyes from 57 individuals with diabetes (19 with no DR, 19 with non-proliferative DR and 19 with proliferative DR who had undergone photocoagulation), and 10 eyes from 10 individuals without diabetes.
Researchers reported a significant decrease in vascular density and a prolonged rod intercept as DR progressed (p<0.01). They found a negative trend between vascular density and the rod intercept; the negative trend in the deep layer (R2=0.28) was more substantial than that in the superficial layer (R2=0.14). Prolonged rod intercept was associated with elevated HbA1c (R2=0.08).
Researchers concluded that vascular density of the macula could be assessed by OCTA, and functional changes in the outer retina could be measured non-invasively by DA. They determined that the severity of vascular density decrease and DA prolongation were proportional to DR progression. Furthermore, they wrote, decreased deep retinal vascular perfusion density and impaired DA response were correlated to (and showed an associated negative trend based on) DR severity.
Source: Hsiao CC, Hsu HM, Yang CM, et al. Correlation of retinal vascular perfusion density with dark adaptation in diabetic retinopathy. Graefes Arch Clin Exp Ophthalmol 2019; Apr 17. [Epub ahead of print].
FDA Accepts Aerie’s IND Application for Sustained-Release Implant
Aerie Pharmaceuticals announced that the FDA reviewed and accepted its Investigational New Drug Application for AR-13503, a novel multi-kinase (rho-kinase/protein kinase C [ROCK/PKC]) inhibitor sustained-release implant. This allows Aerie to initiate human studies in the treatment of neovascular age-related macular degeneration and diabetic macular edema. The IND was submitted in March 2019, and Aerie expects to initiate a first-in-human clinical study later in the second quarter of 2019. Read more.
Innovent Announces First Patient Dosed in Phase I Trial of its Wet AMD Treatment
Innovent Biologics announced that the first patient was successfully dosed in a Phase I clinical trial of IBI302, a novel recombinant fully human bi-specific fusion protein targeting vascular endothelial growth factor and complement proteins, for the treatment of wet age-related macular degeneration. The open-label, single-center, dose escalation clinical trial will evaluate the safety and tolerability of IBI302 in a single intravitreal injection in patients with wet AMD. Read more.
B+L to Initiate Technolas Teneo Excimer Laser Trials, Announces New Divisional Leadership
Bausch + Lomb will initiate a series of U.S. clinical trials to evaluate the safety and efficacy of Technolas Teneo excimer laser for vision correction surgery for myopia and myopic astigmatism. The company expects the trials to begin by July. The system being studied will be the same as the Technolas Teneo laser (model 2) being sold outside the United States. Read more.
In addition, the company announced the appointment of new leadership in its Pharmaceuticals and Consumer Health Care divisions in the United States. Yolande Barnard, former vice president of marketing and sales for U.S. Neurology at Bausch Health, will serve as vice president and general manager for B+L’s U.S. Pharmaceuticals division. Chris Marschall, most recently vice president of marketing for Bausch + Lomb’s U.S. Consumer Health Care business, was promoted to vice president and general manager of U.S. Consumer Health Care. Read more.
Phase II BOULEVARD Study Reveals Several Positive Findings
Roche's and Genentech’s Phase II BOULEVARD study, published in Ophthalmology, showed the investigational molecule, faricimab, was superior to ranibizumab in achieving visual acuity gains for people with diabetic macular edema. Further, the sponsors say that faricimab consistently showed an advantage over ranibizumab in other visual and anatomic outcomes, as well as increased durability, which could potentially mean less frequent treatments for patients. Faricimab is a novel, bispecific antibody that simultaneously binds to and inhibits both vascular endothelial growth factor A and Angiopoietin-2, and is the first bispecific antibody designed specifically for the treatment of retinal eye diseases. The study met its primary endpoint by demonstrating a statistically significant improvement in best-corrected visual acuity in treatment-naïve patients at 24 weeks for faricimab 6 mg versus ranibizumab alone, with an adjusted mean difference of +3.6 letters. Read more.
OliX Names Dr. Vavvas to Scientific Advisory Board
OliX Pharmaceuticals announced that Demetrios G. Vavvas, MD, PhD, joined its Scientific Advisory Board. Dr. Vavvas, who OliX says has pioneered research in diabetic retinopathy, ocular tumors and dry age-related macular degeneration, also serves as an associate professor of ophthalmology at Harvard Medical School and the Monte J. Wallace Ophthalmology Chair in Retina at The Massachusetts Eye and Ear Infirmary. Read more.
Allegro Expands Portfolio with Candidate ALG-1007 for DED Treatment, World-renowned Clinicians Join Cornea Scientific Advisory Board
Allegro Ophthalmics expanded the company's anti-integrin portfolio with drug candidate ALG-1007. ALG-1007 is a topical treatment in development for potential use in patients with dry-eye disease. The company says that pre-clinical and clinical findings of its anti-integrin risuteganib convinced it that it could develop a new anti-integrin compound to treat DED. Allegro also announced that world-renowned clinicians Richard L. Lindstrom, MD; Edward J. Holland, MD; and Eric D. Donnenfeld, MD, joined the company's newly formed Cornea Scientific Advisory Board (Cornea SAB) to provide strategy and direction on Allegro's clinical development pipeline in the areas of corneal disease and dry eye. Dr. Lindstrom will serve as chairperson. Read more.
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