Review of Ophthalmology Online



Vol. 22, #10  •   Monday, March 8, 2021


In this Issue:


Juxtapapillary Deep-layer Microvasculature Dropout & RNFL Thinning in Glaucoma

Researchers aimed to characterize juxtapapillary (JP) and non-JP microvasculature dropout in primary open-angle glaucoma, and compare their rate of retinal nerve fiber layer thinning, as part of a retrospective, cohort study.

A total of 141 eyes with POAG with ≥4 serial optical coherence tomography images after initial OCT angiography for ≥2 years were included. Based on OCTA imaging, the three groups were matched by age and visual field mean deviation: JP group (parapapillary deep-layer microvasculature dropout in contact with the optic disc boundary, n=47); non-JP group (dropout not reaching the optic disc boundary, n=47); and no-dropout group (lacking dropout, n=47). The RNFL thinning rate was compared among the three groups.

Here were some of the findings:
• The rate of RNFL thinning tended to be fastest in the JP group, followed by the non-JP group and no-dropout group in all areas except the temporal and nasal sectors.
• Post hoc analysis revealed that the JP group had significantly faster RNFL thinning than did the no-dropout group in the global area, and the inferotemporal and inferonasal sectors (p<0.05).
• When subgroup analysis was performed for subjects with primarily dropout in the inferotemporal sector, the JP group had significantly faster RNFL thinning than the other two groups in the corresponding sector (p<0.001).

Eyes with JP microvasculature dropout showed faster RNFL thinning than eyes without dropout. Researchers reported the findings suggested that deep-layer microvasculature dropout, especially in contact with the optic disc boundary, is associated with rapid glaucoma progression.

SOURCE: Kwon JM, Weinreb RN, Zangwill LM, et al. Juxtapapillary deep-layer microvasculature dropout and retinal nerve fiber layer thinning in glaucoma. Am J Ophthalmol 2021; Feb 22. [Epub ahead of print].


Early Experience with Brolucizumab Treatment of nAMD

Investigators wrote that since outcome data is limited regarding early experience with brolucizumab, the most recently approved anti-vascular endothelial growth factor agent for the treatment of neovascular age-related macular degeneration, they thought it would be helpful to report clinical outcomes after intravitreous injection (IVI) of brolucizumab 6 mg for nAMD.

This retrospective case series conducted at 15 U.S. private or academic ophthalmological centers included consecutive patients with eyes treated with brolucizumab by six retina specialists between October 17, 2019, and April 1, 2020.

Main outcomes included change in mean visual acuity and optical coherence tomography parameters, including mean central subfield thickness, and presence or absence of subretinal and/or intraretinal fluid. Secondary outcomes included ocular and systemic safety.

A total of 172 eyes from 152 patients (87 women [57.2 percent]; mean age, 80 ±8 years) were included. Here were some of the findings:
• Most eyes (166 [96.5 percent]) had been treated before, and 65.7 percent (109 of 166) were switched from the prior anti-VEGF agent because of persistent fluid detected on optical coherence tomography scans.
• Study eyes received a mean of 1.46 ±0.62 brolucizumab IVIs.
• The mean VA prior to starting brolucizumab was a 64.1 ±15.9 Early Treatment Diabetic Retinopathy Study letter score (Snellen equivalent, 20/50) and a 63.3 (17.2) ETDRS letter score (Snellen equivalent, 20/63) at the last study evaluation (mean difference, 0.8; CI, -2.7 to 4.3; p=0.65).
• No difference was found in mean VA prior to starting brolucizumab compared with VA after brolucizumab IVIs or at the final study evaluation.
• The mean central subfield thickness in eyes prior to starting brolucizumab was 296.7 ±88 μm and at the last study exam was 269.8 ±66.5 μm (mean difference, 26.9 µm; CI, 9 to 44.7 µm; p=0.003).
• Intraocular inflammation was reported in 14 eyes (8.1 percent), was self-limited and resolved without treatment in almost half those eyes (n=6).
• One previously reported eye (0.6 percent) had occlusive retinal vasculitis and severe loss of vision.

Investigators found that brolucizumab IVI for nAMD yielded stable VA with a reduction in central subfield thickness. They added that intraocular inflammation events ranged from mild with spontaneous resolution, to severe occlusive retinal vasculitis in one eye.

SOURCE: Enríquez AB, Baumal CR, Crane AM, et al. Early experience with brolucizumab treatment of neovascular age-related macular degeneration. JAMA Ophthalmol 2021; Feb 25. [Epub ahead of print].


Infectious Keratitis After Boston Type 1 Keratoprosthesis Implantation

Scientists identified the incidence, risk factors and outcomes of infectious keratitis after Boston type 1 keratoprosthesis (KPro) implantation, as part of a retrospective case series of KPro procedures at the Stein Eye Institute and the Centre Hospitalier de l'Université de Montréal between May 1, 2004, and December 31, 2018.

Data were collected on ocular history, operative details, postoperative management, microbiologic profile, treatment and outcomes. Log-rank test and Cox proportional hazard ratio were used to evaluate a possible association between risk factors and outcomes.

A total of 349 KPro procedures were performed in 295 eyes of 268 patients. Here were some of the findings:
• Fifty-seven cases of presumed infectious keratitis were identified after 53 procedures (15.2 percent) in 50 eyes (16.9 percent) of 49 patients (18.3 percent).
• The incidences of culture-positive bacterial and fungal keratitis were 0.014 and 0.004 per eye-year, respectively.
• Persistent corneal epithelial defect formation (p<0.001) and cicatricial disease (HR: 1.98; CI, 1.02 to 3.83) were associated with a significantly higher incidence of infectious keratitis.
• For 53 cases with a known outcome, medical therapy achieved resolution of infection in 34 cases (64.2 percent), while KPro explantation was required in 19 cases (35.8 percent).
• Infectious keratitis was associated with an increased risk for KPro explantation (HR: 3.09; CI, 1.92 to 4.79).

Scientists wrote that the observed rate of microbial keratitis in the study suggests a need for additional topical antimicrobial prophylaxis in eyes at higher risk, such as those with preexisting cicatricial disease or postoperative persistent corneal epithelial defect formation.

SOURCE: Ghaffari R, Bonnet C, Yung M, et al. Infectious keratitis after Boston Type 1 keratoprosthesis implantation. Cornea 2021; Feb 24. [Epub ahead of print].


Imaging Biomarkers to Predict Responsive & Unresponsive Cases Treated with Standardized Anti-VEGF Regimen in nAMD

Researchers sought to determine structural predictors of treatment response in neovascular age related macular degeneration by analyzing optical coherence tomography-related biomarkers.

A retrospective review of patients undergoing treatment for nAMD at a tertiary institute were reviewed at presentation. A high-intensity regimen included eyes on long-term anti-vascular endothelial growth factor treatment unable to extend beyond a month without a relapse and needing double the dose of medication (n=25). A low-intensity regimen included eyes that went into long-term remission after at least three injections and remained dry for more than a year until the last visit (n=20). Multimodal imaging such as fluorescein angiogram, OCT and comprehensive ocular evaluation were used. Choroidal vascularity index, total choroidal area, luminal area, subfoveal choroidal thickness, choriocapillaris thickness, and Haller’s and Sattler’s layer thickness were analyzed for statistical significance.

Researchers found the groups had no significant difference at baseline in age, gender, incidence of reticular pseudodrusen, polypoidal choroidal vasculopathy features on OCT, type of choroidal neovascular membrane or geographic atrophy. Multinomial logistic regression revealed that thicker SFCT and larger total choroidal area were the significant predictors of poor response to anti-VEGF treatment (E=0.02, p=0.02; E=1.82, p=0.0075).

Researchers concluded that greater subfoveal choroidal thickness and larger total choroidal area were useful variables to predict a poor treatment response.

SOURCE: Jhingan M, Cavichini M, Amador M, et al. Choroidal imaging biomarkers to predict highly responsive and resistant cases treated with standardized anti-vascular endothelial growth factor regimen in neovascular age related macular degeneration. Retina 2021; Feb 24. [Epub ahead of print.]




Industry News

Glaukos Announces Phase III Trial Results for iLink Epi-on Cross-linking

Glaukos announced that U.S. Phase III pivotal trial results for its next-generation corneal cross-linking iLink therapy, Epi-on, for the treatment of keratoconus met the study’s primary efficacy endpoint, demonstrating a statistically significant improvement in maximum corneal curvature (Kmax) at six months from baseline between the treated and placebo-controlled arms. Read more.



Clearside Completes Patient Dosing in First Cohort of Phase I/IIa CLS-AX Trial

Clearside Biomedical announced completion of dosing in the first cohort of OASIS, its ongoing Phase I/IIa clinical trial of CLS-AX (axitinib injectable suspension) in patients with wet AMD. CLS-AX is administered by suprachoroidal injection. The primary endpoint for the trial will assess the safety and tolerability of CLS-AX for three months following the administration of the drug. Read more.



FDA Trials Fire Up

Three companies saw the FDA accept their New Drug Applications recently. The NDAs included:
• MydCombi (tropicamide 1% and phenylephrine 2.5%; Eyenovia), a fixed-combination mydriatic agent for use in comprehensive eye exams. The drug is delivered in micro-dose form via the company’s no-touch Optejet dispenser.
• OC-01 (varenicline; Oyster Point Pharma), a nasal spray for the treatment of signs and symptoms of dry eye. OC-01 was given priority review designation, and won’t require an advisory committee meeting, according to the agency. The FDA has until the fourth quarter of 2021 to complete its review of the products.
• A supplemental New Drug Application for Dextenza (dexamethasone ophthalmic insert, Ocular Therapeutix) for the treatment of ocular itching associated with allergic conjunctivitis

Iridex Collaborates with Topcon

Iridex has entered into a “strategic collaboration” with Topcon. The collaboration includes three main agreements, under the terms of which Topcon will acquire exclusive distribution of Iridex laser systems, delivery devices and disposable probes to be sold through its networks in Asia Pacific and EMEA regions. Concurrently, Iridex will add Topcon’s PASCAL systems to its U.S. direct sales and global distribution network. Further, Iridex will acquire the design and manufacturing operation of Topcon’s PASCAL product line. Read more.



Complimentary CME Education Videos




Foundation Fighting Blindness to Host Online CME (COPE) Webinar

The Foundation Fighting Blindness will jointly host an online continuing medical education (CME and COPE) course April 5 at 7 p.m. Eastern Time offering 1 CME or COPE credit. More than 40 clinical trials for emerging retinal degenerative disease therapies are underway, offering hope for patients and the opportunity for them to participate in the research. The course will:
• discuss why it’s important for patients with inherited retinal diseases such as retinitis pigmentosa, Stargardt’s disease, and age-related macular degeneration to know about clinical research;
• provide patient perspectives on clinical trials; and
• offer insights about the clinical trial process from the perspective of investigators. The course will be delivered by Alan Kimura, MD, PhD, president of and a partner at Colorado Retina. Read more.

Envision Sets Agenda for Spring Conference

Envision has finalized the agenda for its Spring 2021 Conference, a two-day event to be livestreamed on March 26 to 27. The virtual conference and Envision Conference East are multidisciplinary events focused on disseminating the latest advancements in rehabilitation techniques, research and technology surrounding low vision and low-vision rehabilitation. Envision Conference East will be held August 20 to 21 at The Ohio State University College of Optometry in Columbus. Learn more.

Keeler Names VanArsdale VP of Business & Channel Management

Keeler announced the promotion of Eugene R. VanArsdale to vice president of business and channel management for the Americas. He will be responsible for the strategic growth of established partnerships with group purchasing organizations, corporate accounts, optometry and ophthalmology schools, and national dealers across the Americas. Together with his team, he will also identify key opportunities to help grow Keeler’s product portfolio pipeline, the company says.














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