From the editors of Review of Ophthalmology:
MARCH IS WORKPLACE EYE WELLNESS MONTH
In this issue: (click heading to view article)
Risk Factors for Developing Subretinal Fibrosis in nAMD Eyes
Researchers assessed the prevalence of and risk factors for subretinal fibrosis (SRFi) in eyes with neovascular age-related macular degeneration that underwent vascular endothelial growth factor inhibitor treatment for up to 10 years.
They performed a cross-sectional and longitudinal analysis on data from a neovascular age-related macular degeneration registry. The presence and location of SRFi were graded by the treating practitioner. Visual acuity, lesion characteristics (type, morphology and activity) and treatment administered at each visit were recorded. Here were some of the findings:
• The prevalence of SRFi in 2,914 eyes rose from 20.4 percent at year interval zero, to 40.7 percent at year interval nine to 10.
• The incidence in 1,950 eyes was 14.3 percent at baseline and 26.3 percent at 24 months.
• Independent characteristics associated with SRFi included:
o poorer baseline vision (adjusted OR, 5.33; CI, 4.66 to 7.61) for visual acuity ≤35 letters vs. visual acuity ≥70 letters, p
o baseline lesion size (adjusted OR, 1.08; CI, 1.08 to 1.14) per 1,000 µm, p
o lesion type (adjusted OR, 1.42; CI, 1.17 to 1.72) for predominantly classic vs. occult lesions, p
o proportion of active visits (adjusted OR, 1.58 [CI, 1.25 to 2.01] for the group with the highest level of activity vs. the lowest level of activity, p
Researchers determined that subretinal fibrosis was found in 40 percent of eyes after 10 years of treatment. They added that high rates of lesion activity, predominantly classic lesions, poor baseline vision and larger lesion size seemed to be independent risk factors for SRFi.
SOURCE: Teo KYC, Joe AW, Nguyen V, et al. Prevalence and risk factors for the development of physician-graded subretinal fibrosis in eyes treated for neovascular age-related macular degeneration. Retina 2020; Feb 17. [Epub ahead of print].
Anti-inflammatory Medication Post-cataract Surgery & Posterior Capsular Opacification
Investigators evaluated the role of anti-inflammatory medication post-cataract surgery on the formation of posterior capsular opacification, as part of a cohort study.
The retrospective registry analysis looked at a single eye from each of 25,818 consecutive individuals who underwent cataract surgery between 2014 and 2018 at Helsinki University Hospital in Finland. They compared Nd:YAG laser capsulotomy rates between individuals treated postoperatively with topical steroids, non-steroidal anti-inflammatory medications or a combination of the two. And they used Kaplan-Meier and Cox regression analyses. Main outcomes were confirmed against a second independent dataset.
A total of 13,368 individuals were included in the analysis, with a mean age of 73.2 ±9.7 years; 61.7 percent were female. Here were some of the findings:
• Pseudoexfoliation was noted in 10.1 percent of cases.
• The mean follow-up time was 22.8 ±15.7 months.
• Patients were treated with steroid monotherapy (28.9 percent of cases), NSAIDs monotherapy (62.2 percent) or a combination of both (8.9 percent).
• Treatment with steroids resulted in significantly lower Nd:YAG capsulotomy rates compared with NSAIDs (HR, 0.76; CI, 0.62 to 0.93, p=0.009).
• Treatment with combination therapy of steroids and NSAIDs showed no added benefit over steroid monotherapy (HR, 1.11; CI, 0.68 to 1.80, p=0.674).
• Cox regression analysis adjusted for patients’ age, gender, pseudoexfoliation and risk stratification remained significantly predictive for lower capsulotomy rates with steroid treatment over NSAIDs (HR, 0.70; CI 0.52 to 0.88, p=0.001).
Investigators determined that use of postoperative steroid treatment in patients undergoing uncomplicated cataract surgery was associated with lower rates of clinically significant posterior capsule opacification compared with treatment with NSAIDs alone. They added that combination therapy of steroids and NSAIDs had no added benefit over steroids alone.
Source: Hecht I, Karesvuo P, Achiron A, et al. Anti-inflammatory medication after cataract surgery and posterior capsular opacification. Am J Ophthalmol 2020; Feb 13. [Epub ahead of print].
Aflibercept Reduces Retinal Hemorrhages & IRMAs but Not Venous Beading: CLARITY Analysis
The CLARITY study was a Phase IIb, non-inferiority study comparing panretinal laser photocoagulation with intravitreal aflibercept in individuals with proliferative diabetic retinopathy. Approximately half of the individuals receiving anti-VEGF therapy showed significant improvement in their DR severity score (DRSS), particularly at DRSS level 47/53 (moderately severe/severe non-proliferative DR), scientists wrote. Level 47/53 consisted of three main features, namely deep hemorrhages (DHs), venous beading (VB) and intraretinal microvascular abnormalities (IRMAs). Scientists wrote that it was unclear whether these features responded to anti-VEGF therapies differently.
As part of a post-hoc analysis of the CLARITY Study, treatment-naïve participants were randomized to intravitreal aflibercept. Scientists reanalyzed the fundus images at baseline, week 12 and week 52 to assess the changes of the three main features in DRSS Level 47/53 in those who were treatment naïve and had received aflibercept. Main outcome measures included changes in DHs, VB and IRMAs after aflibercept therapy at weeks 12 and 52.
Fifty-five treatment-naïve eyes at baseline who received aflibercept were included in the study. Here were some of the findings:
• Severe DHs and severe IRMAs improved in approximately 75 percent of eyes at week 12 and mostly remained improved at week 52; VB remained unchanged in all eyes at week 12.
• From 12 weeks, 32 eyes that had injections showed improved or stable DHs compared with seven that didn’t have injections, and DHs deteriorated in six eyes with no further injections compared with four that had more injections (p
• A total of 15 eyes that continued to have injections from week 12 showed an improvement or stable IRMAs compared to four that didn’t have injections (p
• Worsening of IRMAs was seen in five eyes with no further injections compared with four eyes that continued to have injections.
• The improvements of DHs and IRMAs were more likely to be maintained if less than 16 weeks elapsed since the last anti-VEGF injection.
Scientists found that aflibercept appeared to improve DHs and IRMAs after just three injections. They added that, once the frequency of injections was reduced, DHs and IRMAs could deteriorate again. Furthermore, they wrote, it was unclear whether these results could be translated to patients without PDR.
SOURCE: Pearce E, Chong V, Sivaprasad S, et al. Aflibercept reduces retinal hemorrhages and intravitreal microvascular abnormalities but not venous beading: Secondary analysis of CLARITY study. Ophthalmology Retina 2020; Feb 11. [Epub ahead of print].
Longitudinal Change of ß-Zone Parapapillary Atrophy in POAG vs. Normal Eyes
Researchers looked at longitudinal changes of beta-zone parapapillary atrophy (ß-zone PPA) in primary open-angle glaucoma and normal eyes, as part of a longitudinal, observational study.
They included 153 POAG eyes and 105 normal eyes followed for 10 years or longer, with disc photography performed every year. The topographic parameters of ß-zone PPA (area, maximal radial extent, angular extent around disc) were measured. Factors associated with the enlargement of ß-zone PPA parameters were assessed by odds ratios using multivariable logistic regression.
Main outcome measures included the enlargement of ß-zone PPA parameters and associated factors. Here were some of the findings:
• Over the course of the average 11.6 ±1.3-year follow-up period, enlargement of the β-zone PPA was detected in 66.7 percent of POAG eyes and in 26.7 percent of normal eyes.
• The incremental change in PPA was significantly more common in POAG eyes than in normal eyes (all p
• The spatial distribution of maximal radial extent at baseline and final visit was significantly different between the two groups: POAG eyes, inferotemporal (chi square=26.549, p
<0.001) vs. normal eyes, temporal (chi square=19.320, p
• The widening of radial extent was significantly associated with older age (OR: 1.036, p
=0.010) and the presence of glaucoma (OR: 2.599, p
• The increment of angular extent was associated with the presence of glaucoma (OR: 12.167, p
=0.017) and optic disc hemorrhage (OR: 3.266, p
Researchers found that the pattern of ß-zone PPA change differed between POAG and normal eyes during a follow-up period of 10 years or more. They determined that the enlargement of PPA occurred more frequently in POAG than in normal eyes. And they reported that the widening of radial extent was associated with older age and glaucoma, while incremental changes in angular extent were associated with glaucomatous damage.
SOURCE: Bak E, Ha A, Kim YW , et al, et al. Ten-year-and-beyond longitudinal change of ß-zone parapapillary atrophy: Comparison of primary open-angle glaucoma with normal eyes. Ophthalmology 2019; Feb. 19. [Epub ahead of print].
FIRST SUSTAINED-RELEASE GLAUCOMA IMPLANT APPROVED
The US FDA approved Allergan's bimatoprost implant, Durysta, which is the first intracameral biodegradable sustained-release implant designed to lower intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
The implant delivers 10 µg of bimatoprost over an extended period of time. In the 20-month trials, the “primary efficacy” period studied was 12 weeks. It comes in a preloaded, single-use applicator to facilitate the administration directly into the anterior chamber.
As previously mentioned, researchers assessed the safety and efficacy of the bimatoprost implant in two Phase III trials known as ARTEMIS that lasted for 20 months (including an eight-month extended follow-up) that enrolled 1,122 patients with OAG or OHT. It was compared against twice daily topical timolol drops, according to a company news release.
In both trials, Allergan says Durysta reduced IOP by about 30 percent from baseline over the 12-week primary efficacy period, meeting the predefined criteria for non-inferiority to timolol. Read more.
Eyevance Relaunches Tobradex ST
Eyevance Pharmaceuticals announced the U.S. relaunch of Tobradex ST (tobramycin/dexamethasone ophthalmic suspension) 0.3%/0.05% (originally approved by the FDA in 2009, when the drug was marketed by Alcon), a fixed-dose topical antibiotic and steroid combination. The company acquired the product in late 2019. Read more.
ImprimisRx Announces Supply Agreement with VCNA
ImprimisRx entered into a product supply agreement with Vision Center Network of America that will make ImprimisRx a VCNA preferred provider for a variety of surgical formulations, including a portfolio of topical and injectable products. VCNA is a clinically integrated network of ophthalmic ambulatory surgery centers serving patients primarily in the New York and New Jersey area. Read more.
Study Advances Gene Therapy for X-linked RP
A new study published online Feb. 24 in Nature Medicine reveals promise for development of a gene therapy for X-linked retinitis pigmentosa. Researchers at Miami’s Bascom Palmer Eye Institute took part in the international multicenter study and are actively participating in further clinical trials. Eighteen patients took part in the six-month Phase I/II dose escalation clinical trial for X-linked RP caused by the RPGR gene mutation, which blocks production of a protein necessary for proper functioning of the photoreceptor cells in the retina. The results from the initial trial showed no significant safety concerns after gene therapy surgery, and visual field improvements were observed in some patients. Read more.
Translational Imaging Innovations Receives NIH SBIR Award
Translational Imaging Innovations received a Direct-to-Phase II Small Business Innovation Research award from the National Eye Institute, enabling TII to develop the first diagnostic database of photoreceptor patterning in the human retina. The goal is to create cellular-level biomarkers of degenerative eye disease. The award is a collaboration between TII and the Advanced Ocular Imaging Program at the Medical College of Wisconsin. Read more.
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