Review of Ophthalmology Online



Vol. 23, #17  •   Monday, May 2, 2022


In this Issue:





Rates of VF Change in Glaucoma Patients and Healthy Individuals: 25-Year Follow-up

Researchers assessed the rates of visual field change in patients receiving treatment for glaucoma compared with healthy individuals over an extensive follow-up period and quantified the impact of important covariates for these rates.

This prospective longitudinal cohort study was conducted in a hospital-based setting from January 1991 to February 2020. The study included 40 patients receiving treatment for open-angle glaucoma and 29 healthy participants. One eye of each participant was randomly selected as the study eye.

Glaucoma patients and healthy participants received testing with standard automated perimetry every six months. Individual rates of mean sensitivity change were computed using ordinary least-squares regression analysis. Linear mixed-effects modeling was used to estimate the mean rates of sensitivity change in the two groups, and the impact of baseline mean sensitivity, baseline age and follow-up intraocular pressure for rate estimates.

The main outcome measure was the rate of mean sensitivity change in patients with glaucoma and healthy participants.

A total of 40 patients with glaucoma (median age, 53.07 years [IQR, 48.34 to 57.97 years]; 21 men [52 percent]) and 29 healthy participants (median age, 48.80 years [IQR, 40.40 to 59.07 years], 17 women [59 percent]) were followed for a median of 25.65 years (IQR, 22.49 to 27.02 years) and 19.56 years (IQR, 16.19 to 26.21 years), respectively. Most participants (65 individuals [94 percent) self-identified as White, with the exception of two patients with glaucoma (one self-identified as Black and one as South Asian) and two healthy participants (both self-identified as South Asian). Here are some of the findings:
• The mean follow-up IOP of patients with glaucoma (median, 15.83 mm Hg [IQR, 13.05 to 17.33 mmHg]) was similar to that of healthy participants (median, 14.94 mm Hg [IQR, 13.28-16.01 mm Hg]; p=0.25).
• In an ordinary least-squares regression analysis, 31 patients (78 percent) with glaucoma had rates of mean sensitivity change within the range of healthy participants (i.e., between -0.20 dB/y and 0.15 dB/y).
• Linear mixed-effects modeling revealed the mean (SE) rate of sensitivity change in healthy participants was 0.003 (0.033) dB/y (CI, -0.062 to 0.068; p=0.93).
• In comparison, patients with glaucoma had a mean (SE) rate of sensitivity change that was -0.032 (0.052) dB/y faster, but this difference wasn’t statistically significant (CI, -0.134 to 0.070; p=0.53).
• Among covariates, only baseline mean sensitivity was associated with the rate of mean sensitivity change (mean [SE], 0.021 [0.010] dB/y/dB; CI, 0.002 to 0.041; p=0.03).

Researchers reported, over a median follow-up of more than 25 years, the rate of visual field change in patients receiving treatment for glaucoma was comparable to that of healthy individuals. They suggested the findings could help guide clinical management decisions.

SOURCE: Giammaria S, Hutchison DM, Rafuse PE, et al. Rates of visual field change in patients with glaucoma and healthy individuals: Findings from a median 25-year follow-up. JAMA Ophthalmol 2022; Apr 7. [Epub ahead of print].




Thiazolidinedione Use & Retinal Fluid in CATT

Thiazolidinediones, commonly used antidiabetic medications, have been associated with an increased risk of development of diabetic macular edema and increased vascular endothelial cell permeability. Macular neovascularization in age-related macular degeneration and associated fluid leakage may be influenced by thiazolidinediones. This study aimed to determine the association between thiazolidinedione usage and retinal morphological outcomes or visual acuity in patients treated with bevacizumab or ranibizumab for neovascular AMD.

The secondary analysis of data from the Comparison of Age-related Macular Degeneration Treatments Trials included participant self-reported diabetes status and thiazolidinedione usage at baseline. Visual acuity; intraretinal, subretinal and subretinal pigment epithelium fluid; and foveal thickness of retinal layers were evaluated at baseline and during two-year follow-up. Comparisons of outcomes between thiazolidinedione usage groups were adjusted by macular neovascularization lesion type in multivariable regression models.

Patients taking thiazolidinedione (n=30) had lower adjusted mean VA score at baseline (difference -6.2 letters; p=0.02), increased intraretinal fluid at year two (75 vs. 50 percent, adjusted OR 2.8; p=0.04), greater mean decrease in subretinal tissue complex thickness from baseline at year one (difference -75.1 um; p=0.02) and greater mean decrease in subretinal thickness at year one (difference -41.9 um; p=0.001) and year two (difference -43.3 um; p=0.001).

In this exploratory analysis, diabetic patients taking thiazolidinediones who were treated with bevacizumab or ranibizumab for nAMD had worse baseline mean VA, greater reductions in subretinal and subretinal tissue complex thickness from baseline, and increased IRF compared to patients not taking thiazolidinediones.

SOURCE: Core JQ, Hua P, Daniel E, et al; Comparison of Age-related Macular Degeneration Treatments Trials (CATT) Research Group. Thiazolidinedione use and retinal fluid in the comparison of age-related macular degeneration treatments trials. Br J Ophthalmol 2022; Apr 15. [Epub ahead of print].





Changes in Iris Vasculature & Blood Flow in Patients with Refractive Errors

Scientists evaluated the association between microvascular changes in the iris and refractive errors, as part of a cross-sectional case study.

Seventy eyes from 70 patients with refractive errors were enrolled. Iris microvasculature was analyzed using optical coherence tomography angiography. Scientists divided the iris images into three regions and calculated the vessel area density and vessel skeleton density of the inner one-third, inner two-thirds and entirety of the iris.

Here are some of the findings:
• The vessel area density and vessel skeleton density of various regions were significantly different among patients with refractive errors.
• The vessel area density and vessel skeleton density of the inner one-third of the iris were higher in patients with refractive errors than that of other regions.
• The iris blood vessels were denser near the pupil margin, and blood vessels from the iris root to the pupil edge were radially distributed.
• The vessel area density and vessel skeleton density of patients with mild hyperopia and emmetropia were higher than those of patients with moderate and high myopia.
• As the spherical equivalent increased, the vessel area density and vessel skeleton density of the iris increased.
• Neither age nor sex contributed to significant differences in vessel area density and vessel skeleton density.

Scientists concluded that quantitative changes in iris microvasculature may indicate the development of myopia.

SOURCE: Jia Y, Xue W, Wang Y, et al. Quantitative changes in iris vasculature and blood flow in patients with different refractive errors. Graefes Arch Clin Exp Ophthalmol 2022; Apr 11. [Epub ahead of print].


Complimentary CME Education Videos



Macular Atrophy in Eyes with nAMD in the Ladder Trial

Genentech researchers evaluated whether macular atrophy rates differed in eyes with neovascular age-related macular degeneration treated continuously with the company’s Port Delivery System with ranibizumab (PDS; now approved with the brand name Susvimo) vs. ranibizumab given as a bolus intravitreal injection.

The preplanned exploratory analysis was based on a Phase II, multicenter, randomized, active treatment-controlled, dose-ranging study.

Participants included patients diagnosed with nAMD within nine months of screening who had received at least two previous intravitreal anti-vascular endothelial growth factor injections of any agent and were responsive to treatment.

Eyes were randomized (3:3:3:2) to treatment with the PDS (filled with a customized formulation of ranibizumab 10 mg/ml, 40 mg/ml, or 100 mg/ml and refilled pro re nata) or monthly intravitreal ranibizumab 0.5 mg injections.

Main outcome measures included macular atrophy prevalence, incidence and progression.

The analysis population consisted of 220 eyes (58, 62, 59 and 41 eyes in the PDS 10 mg/ml, 40 mg/ml, 100 mg/ml and monthly intravitreal ranibizumab 0.5 mg injection arms, respectively). Here are some of the findings:
• At study baseline, MA was observed in 14.5 percent (PDS, 10 mg/ml), 11.5 percent (PDS, 40 mg/ml), 13.6 percent (PDS, 100 mg/ml) and 7.6 percent (monthly ranibizumab) of eyes.
• At last assessment (mean, 22.1 months), MA prevalence had increased to 38.6 percent (PDS, 10 mg/ml), 40 percent (PDS, 40 mg/ml), 40.4 percent (PDS, 100 mg/ml) and 45.7 percent (monthly ranibizumab).
• In patients without MA at baseline, a higher proportion of eyes in the monthly ranibizumab arm (40.6 percent) developed MA vs. PDS arms (28.6 percent, 32.1 percent and 30.6 percent of eyes in the PDS 10 mg/ml, 40 mg/ml and 100 mg/ml arms, respectively).
• Mean change in MA area from baseline to last assessment for PDS 10 mg/ml, 40 mg/ml, 100 mg/ml and monthly ranibizumab arms was +2.46 mm2, +1.61 mm2, +1.09 mm2 and +1.15 mm2, respectively.
• At nine months, for patients without MA at baseline, the difference in incidence of MA between PDS 100 mg/ml and monthly ranibizumab groups (95 percent confidence interval) was -12 percent (-31 percent, 7 percent).

Researchers wrote that, in the Phase II Ladder trial, no evidence of worse MA with the PDS relative to monthly intravitreal ranibizumab 0.5 mg injections was found. They advised that larger trials focusing on MA are needed to confirm this finding.

SOURCE: Jaffe GJ, Cameron B, Kardatzke D, et al. Prevalence and progression of macular atrophy in eyes with neovascular age-related macular degeneration in the Phase 2 Ladder trial of the port delivery system with ranibizumab. Ophthalmol Retina 2022; Apr 12. [Epub ahead of print].




Industry News

ARVO Presentations

The following companies announced presentations at the at the Association for Research in Vision and Ophthalmology annual meeting being held May 1 to 4 in Denver, and May 11 to 12 virtually.
• Ocular Therapeutix announced multiple scientific presentations. Learn more.
• Ocuphire Pharma announced four poster presentations on APX3330 and Nyxol. Learn more.
• ProQR Therapeutics N.V. announced several presentations. Learn more.
• Allegro Ophthalmics announced that four scientific posters involving risuteganib, the company’s lead investigational compound in retina, will be presented. Learn more.
• Visus Therapeutics will present new scientific data on Brimochol PF, the company’s lead product candidate for the treatment of presbyopia. Read more.
• Aerie Pharmaceuticals will present posters highlighting research findings on topics ranging from netarsudil to new product candidates including a new class of corticosteroid anti-inflammatories. Read more.
• Genentech will be presenting two-year, Phase III results on efficacy and durability of Vabysmo in diabetic macular edema, as well as results from a study which predicts the progression of diabetic retinopathy:
   - Efficacy, durability, and safety of faricimab in diabetic macular edema: 2-year results from the Phase III YOSEMITE and RHINE trials; and
   - Personalized treatment interval (PTI) dosing dynamics over 2 years in the Phase III YOSEMITE and RHINE trials of faricimab in diabetic macular edema
• Oyster Point says new analyses of the pivotal trial data for its dry eye nasal spray Tyrvaya will be presented at ARVO. Read more.
• Allergan will present new data on Vuity (pilocarpine HCl ophthalmic solution) 1.25%, the first FDA-approved eye drop for the treatment of presbyopia in adults, and Durysta (bimatoprost intracameral implant) biodegradable implant to lower eye pressure for glaucoma patients. Learn more.
• Bausch + Lomb will present 13 scientific poster presentations, including results from the second of two Phase III trials of the investigational treatment NOV03 (perfluorohexyloctane), as well as from several studies involving products from the company’s consumer health care, pharmaceutical and surgical portfolios, such as Xipere (triamcinolone acetonide injectable suspension) for suprachoroidal use. In addition, an update on Bausch + Lomb’s ongoing Antibiotic Resistance Monitoring in Ocular micRoorganisms (ARMOR) surveillance study will be presented. Learn more. Read more.

ASCRS Announcements

• Bausch + Lomb announced data from the first Phase III trial (GOBI) of NOV03 (perfluorohexyloctane) was part of a podium presentation. Highlights included that on day 57, change from baseline in total corneal fluorescein staining was statistically significant in the NOV03 arm compared to the control saline group (-2 [2.6] vs. -1.0 [2.7]) (p<0.001)(primary endpoint), and the eye dryness VAS score was statistically significantly improved in the NOV03 arm compared to control group (-27.4 [27.9] vs. -19.7 [26.6]) (p<0.001) (primary endpoint). Read more.
• Orasis Pharmaceuticals announced Phase IIb data demonstrating the efficacy and safety of its novel eye drop candidate, CSF-1, for the treatment of presbyopia. The trial served as the foundation for the design and conduct of the Phase III NEAR-1 and NEAR-2 clinical trials of CSF-1. Read more.


Bausch + Lomb Goes Public with IPO

Bausch + Lomb announced the launch of its IPO and the commencement of the “roadshow” for it. A wholly owned subsidiary of Bausch Health (the Selling Shareholder) is offering 35 million common shares of B+L. The Selling Shareholder also intends to grant the underwriters a 30-day option to purchase up to an additional 5.25 million common shares of Bausch + Lomb to cover over-allotments, if any, the company says. The IPO price is currently expected to be between $21 and $24 per share. Read more.

ForeseeHome AMD Remote Monitoring Study

Notal Vision reported findings from a company-sponsored study, “Analysis of Long-term visual Outcomes of ForeseeHome Remote Telemonitoring (ALOFT)” in Ophthalmology Retina. The company says the study found positive long-term visual outcomes with its AMD home monitoring program. Read more.

J&J Vision Introduces TearScience Activator for MGD Treatment

Johnson & Johnson Vision announced availability of a new product called the TearScience Activator Clear. Building on the foundation of the LipiFlow Thermal Pulsation System, an automated treatment for meibomian gland dysfunction, the TearScience Activator’s design features a single-piece eye cup and translucent design enabling more efficient and accurate positioning for more consistent delivery of heat and pressure across the entire lid, the company says. Read more.

Théa Introduces iVIZIA OTC Products

Théa Pharma recently announced the availability of the iVIZIA line of over-the-counter eye-care products in the United States, including lubricating eye drops, lubricating eye gel and three options for daily hygiene of sensitive eyelids. iVIZIA eye drops offer preservative-free extended relief and ocular surface protection to patients with any type of dry eye, including those who wear contact lenses, the company says. Learn more.

Lineage Announces a Fifth Cell Therapy Program

Lineage Cell Therapeutics announced a new cell therapy development program, photoreceptor neural cell (PNC) transplants for the treatment of vision loss due to photoreceptor dysfunction or damage. Based on recent in vivo data, PNCs may be capable of forming reconstructed retina with high survivability and neural connectivity to surrounding functional layers. Read more.





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