Review of Ophthalmology Online



Vol. 23, #18  •   Monday, May 9, 2022


In this Issue:




Prediction of Central VF Severity in Glaucoma

Researchers evaluated the association between perimetric parameters at abnormal central 12 points on 24-2 visual fields, and the severity of central VF defects on 24-2 VFs and related parafoveal scotomas on 10-2 VFs.

They examined 64 eyes of 56 glaucoma patients with central VF defects on 24-2 VF with a mean deviation greater than -7 dB, and completed 24-2 and 10-2 VF testing within six months. Based on 10-2 VF pattern defects, eyes were organized into three categories:
   1. arcuate parafoveal scotoma, severe defects;
   2. partial arcuate, moderate defects; and
   3. minimal defects
They analyzed VF parameters at abnormal points (p<1 percent) within the central four and paracentral eight points on total deviation/pattern deviation plots on 24-2 VFs to predict the severity of central visual field defects.

Here are some of the findings:
• Eyes with arcuate scotomas showed more functional loss than eyes without arcuate scotoma on 10-2 VFs (p<0.001).
• A significant association was observed between abnormal 24-2 VF points’ (<1 percent) threshold sensitivity lower than 20 dB (OR=7.2; p=0.002 and OR=5.1; p=0.003 for the central four and paracentral eight points respectively), and defect values worse than -15 dB (OR=8 and 5.6 for the central four and paracentral eight points, respectively; p=0.005) with arcuate scotoma on 10-2 VFs.
• Superior nasal defect in the central 5 degrees on 24-2 VF was significantly associated with an arcuate defect on 10-2 VF (p<0.001).

Researchers wrote that the severity of central VF defects on 24-2 VFs and parafoveal scotomas on 10-2 VFs may be predicted by measuring threshold sensitivities and defect values at abnormal central 12 points (<1 percent) on 24-2 VFs in early glaucoma.

SOURCE: Chakravarti T, Moghimi S, Weinreb RN. Prediction of central visual field severity in glaucoma. J Glaucoma 2022; Apr 7. [Epub ahead of print].





Predicting Treatment Frequency of Ranibizumab Injections in DME

Investigators evaluated the predictors of annual treatment frequency in the second year of pro re nata intravitreal ranibizumab injections for diabetic macular edema, as part of a retrospective study.

They reviewed 65 eyes of 60 patients with center-involved DME that received PRN injections after three monthly loading doses. The central subfield thickness and qualitative findings were assessed on spectral-domain optical coherence tomography images. Investigators then sought to determine whether parameters at baseline or at the 12-month visit were associated with treatment frequency in the second year.

Here are some of the findings:
• The number of ranibizumab injections decreased from six (four to eight) during the first year to two (zero to three) during the second year (p<0.001).
• The injection numbers during the first year (ρ=0.259; p=0.037) but not second year (ρ=0.152; p=0.226) were modestly related to the logMAR improvement at 24 months.
• Multivariate analyses revealed that the CST (β=0.336; p=0.005) and hyperreflective walls in the foveal cystoid spaces (β=0.273; p=0.020) at baseline were associated with the number of IVR injections during the second year.
• Treatment frequency during the second year was related to CST (β=0.266, p=0.012), hyperreflective walls (β=0.394, p=0.002) and cumulative doses of ranibizumab injections (β=0.294; p=0.006) at the 12-month visit.

Investigators found that cumulative doses of ranibizumab injections, central subfield thickness and hyperreflective walls in the foveal cystoid spaces at 12-month visits were predictors of the frequency of ranibizumab injections during the second year of treatment for DME.

SOURCE: Nishikawa K, Murakami T, Ishihara K, et al. Factors predicting the treatment frequency of ranibizumab injections during the second year in diabetic macular edema. Jpn J Ophthalmol 2022; Apr 19. [Epub ahead of print].





Disparities in VA Outcomes after Endothelial Keratoplasty

Scientists assessed risk factors for lack of improvement in visual acuity after endothelial keratoplasty, as part of a retrospective cohort study.

Patients ages 18 years and older in the IRIS Registry who underwent EK in the United States between 2013 and 2018 were included.

EK procedures performed between 2013 and 2018 were identified. Change in visual acuity relative to baseline was determined at six months and a year. A multivariable population-average marginal model estimated using Generalized Estimating Equations adjusting for socio-demographic factors, baseline vision, surgical indication, ocular comorbidities and postoperative complications was used to identify factors associated with worse VA outcomes.

Main outcome measures included VA and lack of improvement in vision at one year compared to preoperative status.

A total of 30,600 EK procedures (n=25,666 unique patients) were included in the analysis. Here are some of the findings:
• Overall, VA improved from median logMAR 0.54 (Snellen 20/69)(IQR ±0.70) preoperatively to median logMAR 0.40 (20/50)(IQR ±0.36) at six months and median logMAR 0.30 (20/40)(IQR ±0.36) at one year postoperatively.
• 30.3 percent of the overall cohort, 29.8 percent of the Fuchs’ endothelial corneal dystrophy (FECD) subgroup and 27.4 percent of the bullous keratopathy (BK) subgroup didn’t show visual improvement at one year postoperatively.
• In the FECD subgroup, older age (RR, 1.05 per five-year increase; CI, 1.03 to 1.07) and female sex (RR, 1.10; CI, 1.04 to 1.16) were associated with VA worse than or equal to baseline at one year postoperatively.
• In both FECD and BK subgroups, eyes with higher baseline logMAR VA (per 0.1 unit increase in logMAR) were more likely to have visual improvement postoperatively (FECD: RR, 0.82; CI, 0.81 to 0.84; BK: RR, 0.91; CI, 0.91 to 0.92), whereas postoperative re-bubble procedures (FECD: RR, 1.10; CI,1.02 to 1.19; BK: RR, 1.31; CI, 1.17 to 1.48) and repeat keratoplasties (FECD: RR, 1.41; CI,1.32 to 1.52; BK: RR, 1.42; CI, 1.28 to 1.57) were associated with higher risk of no improvement in VA.

Scientists reported that postoperative re-bubbling procedures and repeat keratoplasties were independent factors associated with worse VA outcomes after EK for FECD and BK subgroups. Older age and female gender were also associated with worse VA outcomes after EK in the FECD subgroup, they added.

SOURCE: Srikumaran D, Son HS, Li C, et al. Disparities in visual acuity outcomes after endothelial keratoplasty - an IRIS Registry Analysis. Ophthalmology 2022; Apr 8. [Epub ahead of print].


Complimentary CME Education Videos



Progression of Atrophy Between Neovascular & Non-Neovascular AMD

Researchers compared enlargement rates over five years of follow-up in geographic atrophy vs. macular atrophy associated with macular neovascularization, as part of a retrospective, longitudinal comparative case series.

Participants included a consecutive series of age-related macular degeneration patients with GA or MA with MNV.

Atrophic regions on serial registered fundus autofluorescence (FAF) images were semi-automatically delineated, and area measurements were recorded every 6 ±3 months for the first two years of follow-up and at yearly intervals up to five years.

Main outcome measures were annual raw and square root transformed atrophy growth rates.

A total of 117 eyes of 95 patients were included (61 in the GA and 56 in the MA cohorts); 100 percent and 38.5 percent of eyes completed two and five years of follow-up, respectively. Here are some of the findings:
• Mean baseline lesion size was similar between the two groups (raw: 1.74 vs. 1.53 mm2; p=0.56; square root transformed: 1.17 vs. 1.02 mm; p=0.26).
• Overall enlargement rates were greater for the GA cohort (raw: 1.72 vs. 1.32 mm2/year; p=0.002; square root transformed: 0.41 vs. 0.33 mm/year; p=0.03), as well as the area of atrophy growth at five years (raw: +8.06 vs. +4.55 mm2; p=0.001; square root transformed: +1.93 vs. +1.38 mm, p=0.02).
• The estimated square root transformed area was also significantly greater for the GA cohort at two years (1.84 vs. 1.67 mm; p=0.01).

Researchers determined that presence of MNV was associated with a slower rate of expansion resulting in overall smaller areas of atrophy over time. They added that these findings support the hypothesis that MNV may protect against the progression of atrophy.

SOURCE: Airaldi M, Corvi F, Cozzi M, et al. Differences in long-term progression of atrophy between neovascular and non-neovascular age-related macular degeneration. Ophthalmol Retina 2022; Apr 20. [Epub ahead of print].




Industry News

Topical Immunomodulator Approved for Vernal Keratoconjunctivitis

Santen says its new therapeutic for vernal keratoconjunctivitis, Verkazia, is a cyclosporine 0.1% emulsion that blocks release of pro-inflammatory cytokines, thereby suppressing the immune system and reducing inflammation. In clinical trials, Santen says Verkazia demonstrated improvements in corneal inflammation (keratitis score) and ocular itching. The company also noted that the most common side effects, typically occurring during instillation, were eye pain (12 percent) and ocular itching (8 percent). Read more.

Zeiss Adds SLT Functionality to Laser

Zeiss recently added a selective laser trabeculoplasty module to its Visulas Green Laser. In addition to perfoming SLT, the company says the laser incorporates the company’s “InsightView” display and “TouchControl” center switch to allow physicians to keep their eyes on the patient while changing parameters during laser therapy. Learn more.


Tarsus Announces Topline Data from Saturn-2 Phase III

Tarsus Pharmaceuticals says that TP-03 (lotilaner ophthalmic solution, 0.25%) met the primary endpoint and all secondary endpoints in the company’s Saturn-2 Phase III trial with a favorable safety profile, demonstrating its ability to resolve Demodex blepharitis cases. With these positive results, Tarsus plans to submit a New Drug Application to the FDA in the second half of 2022. Read more.

Stealth Drug Fails to Meet Primary Endpoints in ReCLAIM-2 Trial

Stealth BioTherapeutics announced that data from its Phase II ReCLAIM-2 trial evaluating elamipretide in patients with geographic atrophy secondary to dry age-related macular degeneration reveal the trial didn’t meet its primary endpoints (mean changes in low-luminance visual acuity and GA). However, it added that a secondary endpoint showed that elamipretide improved visual function for GA patients. Learn more.

Iveric Bio Presents Post Hoc Analysis from GATHER1

Iveric Bio announced a post hoc analysis evaluating the reduction in geographic atrophy lesion growth observed in patients receiving Zimura (avacincaptad pegol) compared to patients receiving sham in the completed GATHER1 clinical trial would be presented at the Retinal World Congress in Fort Lauderdale, Fla. The study analyzes the reduction in GA lesion growth, in a subset of GATHER1 patients, based on the distance of a patient’s GA lesion from the foveal center at baseline. In line with the overall results of GATHER1, a reduction of GA lesion growth in patients receiving Zimura as compared to patients receiving sham was consistently observed across all baseline distances from the foveal center, the company says. Read more.

J&J Vision Appoints Peter Menziuso as Company Group Chairman

Johnson & Johnson Vision announced the appointment of Peter Menziuso as Company Group Chairman to lead the full Johnson & Johnson Vision portfolio. This includes brands such as Acuvue contact lenses, the Tecnis family of intraocular lenses, TearScience LipiFlow and more. Learn more.


The following companies presented these findings at the Association for Research in Vision and Ophthalmology annual meeting, May 1-4, in Denver and virtually.
• Applied Genetic Technologies presented additional findings from the ongoing X-linked retinitis pigmentosa Phase I/II study of AGTC-501, including 18-month safety and efficacy data showing safety and efficacy signals similar to the study’s 12-month findings. Read more.
• Lineage Cell Therapeutics announced that data from the ongoing Phase I/IIa clinical study of RG6501 (OpRegen), a retinal pigment epithelial cell therapy in development to treat geographic atrophy secondary to age-related macular degeneration shows that the treatment has the potential to arrest GA disease progression, particularly when delivered on-target and in earlier disease. Read more.
• Johnson & Johnson Vision presented 26 poster and podium presentations focusing on myopia, cataract, dry eye, vision science and refractive research. Learn more.
• Opthea announced clinical data on the efficacy and safety of OPT-302 in combination with ranibizumab for polypoidal choroidal vasculopathy finding OPT-302 (2.0 mg) used in combination with ranibizumab (0.5 mg) achieved superior visual acuity gains and anatomic improvements compared to monthly ranibizumab monotherapy in these subjects with PCV type CNV. Read more.
• MeiraGTx presented additional clinical data from the Phase I/II trial of botaretigene sparoparvovec for the treatment of X-linked Retinitis Pigmentosa (XLRP). A poster presentation of human retinal organoid vector efficacy data was also presented at the conference, the company says. Read more.

IRIS Registry Sheds Light on Glaucoma Surgery Trends

The 2021 American Academy of Ophthalmology IRIS Registry Report shows a greater than 80-increase in glaucoma surgeries over an eight-year period from 2013 to 2021. According to the report, put out by Verana Health, more than 1 million glaucoma procedures were performed during this time. However, trabeculectomies peaked in 2015 with 14,600 procedures annually, then declined to just 9,300 per year by 2021. Over this same period, there was an increase in implantation of trabecular meshwork bypass stents, the report found. Read more.

Ocuphire Gives Trial Update

Ocuphire Pharma recently announced results from its MIRA-4 pediatric safety trial investigating its product candidate Nyxol for the reversal of pharmacologically-induced mydriasis. The company says the results demonstrated that Nyxol’s efficacy and safety in pediatric subjects 3 to 11 years of age was consistent with that shown in previous studies that enrolled both adolescents (age 12 to 17 years) and adults. Read more.

Samsara to Initiate PMA Supplemental Study of New-generation SING IMT

Samsara Vision announced that it’s initiating a PMA supplemental study to evaluate improvements in visual acuity and the safety of its SING IMT (Smaller-Incision New-Generation Implantable Miniature Telescope) in people living with late-stage AMD. Learn more.








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