Review of Ophthalmology Online

 

 



Vol. 22, #7  •   Monday, February 15, 2021

FEBRUARY IS AGE-RELATED MACULAR DEGENERATION AWARENESS MONTH

In this Issue:
 

 
 

Efficacy & Safety of Ultrasound Cycloplasty for Refractory Glaucoma


Researchers aimed to evaluate the three-year efficacy and safety of ultrasound cycloplasty in patients with refractory glaucoma.

A total of 104 patients with refractory glaucoma recruited from two university hospitals underwent UCP. After the UCP procedure, physicians performed exams at seven days, one week, one month; and three, six, 12, 24 and 36 months. Primary outcomes were therapeutic success at three years (IOP reduction from baseline ≥20 percent and IOP >5 mmHg without other surgical procedure) and vision-threatening complications. Secondary outcomes included mean IOP change from baseline at each follow-up visit, medication use, complications and subsequent UCP and/or other postsurgical interventions.

Here were some of the findings:
• At three years post-UCP, the therapeutic success rate was 55 percent.
• For 75 percent of patients, results were obtained with one procedure.
• For the overall study population, IOP was reduced significantly (p<0.005) from 27.6 ±8.9 mmHg (n=3.0 topical hypotensive medication) to 17 ±6.8 mmHg at 36 months (n=2.8 topical hypotensive medication) (33-percent reduction).
• For successful patients, IOP was 29.3 ±8.8 mmHg (n=3.0 topical hypotensive medications) at baseline and 15.6 ±4.3 mmHg at 36 months (n=2.8 topical hypotensive medication) (43-percent reduction).
• The rate of complications was low, and no cases of phthisis were reported.

Researchers concluded that the UCP procedure was effective, had few reported complications, and should be considered as an alternative to other IOP-lowering therapies, including laser cyclocoagulation, in patients with refractory glaucoma.

SOURCE: Rouland J-F, Aptel F. Efficacy and safety of ultrasound cycloplasty for refractory glaucoma – a 3 year study. J Glaucoma 2021; Feb 1. [Epub ahead of print].

 
 

 
 
 

pRNFL and Microvasculature in Prolonged Type 2 Diabetes Patients


Investigators aimed to identify the effects of prolonged type 2 diabetes (T2DM) on the peripapillary retinal nerve fiber layer (pRNFL) and peripapillary microvasculature in patients with prolonged T2DM without clinical diabetic retinopathy.

Subjects were divided into three groups: controls (153 eyes); patients with T2DM <10 years (DM group 1; 136 eyes); and patients with T2DM ≥10 years (DM group 2; 74 eyes). Investigators compared the pRNFL thickness and peripapillary superficial vessel density. They performed linear regression analyses to identify factors associated with peripapillary vessel density in patients with T2DM.

Here were some of the findings:
• The mean pRNFL thicknesses for the following groups were: controls: 96 ±7.9; DM group 1: 94.5 ±0.9; and DM group 2: 92.2 ±8.2 µm (p<0.001).
• The VDs for the following groups were: controls: 18.24 ±0.62; DM group 1: 17.60 ±1.47; and DM group 2: 17.15 ±1.38 mm−1 (p<0.001).
• In multivariate linear regression analyses, significant factors affecting the peripapillary vessel density in patients with T2DM were: visual acuity (B=-2.460, p=0.001); axial length (B=-0.169, p=0.008); T2DM duration (B=-0.056, p<0.001); and pRNFL (B=0.024, p=0.001).

Investigators wrote that patients with T2DM without clinical DR showed thinner pRNFL, and lower peripapillary vessel density and perfusion density (PD) compared with normal controls. They added that this damage was more severe in patients with T2DM ≥10 years. Furthermore, investigators found peripapillary vessel density was significantly associated with best-corrected visual acuity, axial length, T2DM duration and pRNFL thickness in patients with T2DM.

SOURCE: Lee M-W, Lee W-H, Ryu C-K, et al. Peripapillary retinal nerve fiber layer and microvasculature in prolonged type 2 diabetes patients without clinical diabetic retinopathy. Invest Ophthalmol Vis Sci 2021;62:2:9.
 
 

Conjunctivochalasis and Tear Osmolarity in Dry Eye


Scientists evaluated the hypothesis that ocular surface epithelial thickness is correlated with tear osmolarity, conjunctivochalasis (CCh) and dry eye clinical tests, as part of a case control study.

A total of 50 patients with different types of dry-eye disease, and 15 age- and sex-matched control subjects were enrolled in this study. Scientists performed a diagnostic assessment of tear film and ocular surface parameters, including: the Ocular Surface Disease Index questionnaire; visual analog scale questionnaire; topographic surface regularity and surface asymmetry indices; tear-film breakup time; corneal and conjunctival dye staining; Schirmer I test; and tear osmolarity. The corneal and bulbar conjunctival epithelial thickness (CET) were obtained using the latest version of a spectral-domain optical coherence tomographer.

Here were some of the findings:
• Patients with aqueous deficient DED had lower bulbar CET values particularly in the temporal region than normal subjects and patients with evaporative DED; however, the difference wasn’t statistically significant.
• Patients with DED and CCh had lower bulbar CET values in temporal (38.52 ±9.58 μm) and inferior regions (50.79 ±9.10 μm) compared with those with DED without CCh (47.39 ±11.71 μm, 60.38 ±14.36 μm, respectively, p<0.02).
• In the DED group, tear osmolarity was found to be negatively correlated with CET values in the temporal bulbar region (p=0.006 and r=-0.403) and central corneal epithelial thickness values (p=0.029 and r=-0.325)

Scientists reported that conjunctivochalasis and tear osmolarity were associated with reduced conjunctival epithelial thickness in DED.

SOURCE: Gumus K, Pflugfelder SC. Conjunctivochalasis and tear osmolarity are associated with reduced conjunctival epithelial thickness in dry eye. Am J Ophthalmol 2021; Feb 8. [Epub ahead of print].
 
 

The Effectiveness of IVT Aflibercept in nAMD


Researchers assessed the real-world effectiveness of intravitreal aflibercept injections in Germany in patients with neovascular age-related macular degeneration over 24 months, as part of the PERSEUS prospective, non-interventional cohort study.

The primary endpoint was the mean change in visual acuity from baseline. Secondary endpoints included the proportion of patients with a VA gain or loss of ≥15 letters, and the frequency of injections and exams. Patients with regular (bimonthly after three monthly injections during year one and ≥four injections in year two) and irregular (any other) treatments were analyzed. The last observation carried forward (LOCF) and the observed cases (OC) approach was applied for primary endpoint analysis to account for missing data.

A total of 803 patients were considered for effectiveness analysis. At month 24, only 38 percent of patients were still under observation. The LOCF population included 727, and the OC population included 279 patients. Here were some of the findings:
• Treatment-naïve patients improved by 6.3 letters (LOCF)/8.1 (OC) with regular treatments over 24 months, but only by 3.3 letters (LOCF)/3.1 (OC) with irregular treatment.
• The proportion of treatment-naïve patients achieving a VA improvement of ≥15 letters was similar between regularly and irregularly treated cohorts.
• More patients experienced a VA worsening of ≥15 letters in the irregular cohorts ([LOCF] 18.7 percent) vs. the regular cohorts ([LOCF] 7.4 percent).

Researchers determined that regular IVT-AFL treatment resulted in better VA outcomes than irregular treatment at month 24, although only a minority of patients received regular treatment over a two-year period.

SOURCE: Eter N, Hasanbasic Z, Keramas G, et al; PERSEUS Study Group. PERSEUS 24-month analysis: A prospective non-interventional study to assess the effectiveness of intravitreal aflibercept in routine clinical practice in Germany in patients with neovascular age-related macular degeneration. Graefes Arch Clin Exp Ophthalmol 2021; Feb 6. [Epub ahead of print].
 

 
 


Industry News


LumiThera Completes Patient Enrollment in LIGHTSITE III


LumiThera completed enrollment in its U.S. multicenter clinical study in non-neovascular age-related macular degeneration patients. LIGHTSITE III, using the Valeda Light Delivery System is an FDA-, IDE-approved prospective, randomized, double-masked trial that will follow 100 patients with dry AMD over the course of two years. In addition to safety, key efficacy endpoints include visual acuity, contrast sensitivity and reduction of drusen deposits. Read more.

 

 

NIH Grants Connectyx Exclusive Worldwide License to Repurpose Metformin


Connectyx Technologies entered into an exclusive patent license agreement to practice inventions contained within a group of patent applications with the National Eye Institute of the National Institutes of Health, including the repurposed use of metformin to treat retinal degeneration. Research has shown that metformin can activate AMP-activated protein kinase, reduce vascular endothelial growth factor secretion and correct baseline calcium levels in patients’ retinal pigment epithelium cells. The new treatment indications will require reformulating the drug into an eye drop (or other topical delivery method) or an injectable. Read more.

 

 

New Therapeutic Approach Aimed at Restoring Vascular Health & Reversing Age-related Eye Disease


Unity Biotechnology announced preclinical research revealing a novel mechanism for treating age-related eye diseases by restoring retinal vascular health. In a study, featured in the April issue of Cell Metabolism, researchers from Unity and the University of Montreal demonstrated that diseased blood vessels in the retina trigger molecular pathways associated with aging, collectively termed “cellular senescence.” The researchers used animal models and human samples to identify a molecular target, Bcl-xL, that’s highly expressed in diseased retinal blood vessels. Targeting these senescent cells with a single dose of Unity’s Bcl-xL small molecule inhibitor led to selective elimination of diseased vasculature while enabling functional blood vessels to reorganize and regenerate. Unity is conducting a Phase I clinical trial of UBX1325, a small molecule inhibitor of Bcl-xL, for the treatment of diabetic macular edema. Read more.



J&J Vision Donates to Cataract Charity


Johnson & Johnson Vision announced that it’s donating $20,000 to the Himalayan Cataract Project (HCP)|Cure Blindness in honor of the organization’s dedication to spread cataract awareness. Read more.

 



 

Complimentary CME Education Videos
 

 

 

Prevent Blindness to Hold Annual Eyes on Capitol Hill Advocacy Event


Prevent Blindness will be holding its sixteenth annual Eyes on Capitol Hill advocacy event virtually on Feb. 24 and 25. The program brings together patients, caregivers, public health workers and medical professionals with their elected officials to educate lawmakers and their staff on vision issues, including equitable access to quality eye care, health disparities in the prevalence of vision disorders, and the importance of sight-saving research and surveillance. Learn more.

 

 

News from Gemini Therapeutics


Gemini Therapeutics completed enrollment in its Phase IIa ReGAtta study, a dose escalation trial of GEM103, a recombinant human complement factor H (CFH), in dry AMD patients with CFH loss-of-function gene variants. The trial will evaluate safety and tolerability, as well as measures of intraocular pharmacokinetics and disease-relevant biomarkers. The company also announced the completion of its business combination with FS Development Corp. (Nasdaq: FSDC), a special purpose acquisition company. The resulting combined company will be called Gemini Therapeutics. Read more.
In addition, the company appointed Brian Piekos as chief financial officer. Piekos Piekos joins from AMAG Pharmaceuticals, where he most recently served as executive vice president, chief financial officer and treasurer. Read more.

 

 

Reichert Debuts New Website


Reichert Technologies launched a redesigned website in order to improve the user experience. The company says that the website, still located at reichert.com, is streamlined and modern, and has improved functionality that's been optimized for mobile devices. Reichert adds that the site offers improved security, enhanced navigation and "more robust contact capabilities." Read more.

 

 

 

 

 

 

 

 

 

 


 

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