Review of Ophthalmology Online



Vol. 22, #5  •   Monday, February 1, 2021


In this Issue:



The Upside-Down Technique for the Ahmed Glaucoma Valve

In a retrospective study, researchers aimed to describe the “upside-down technique” for implanting the Ahmed glaucoma valve (AGV), which results in changes in the primary aqueous humor outflow pathway to the scleral side, and evaluate its effectiveness in patients with refractory glaucoma.

The upside-down technique was used for pars plana AGV implantation in 10 eyes of 10 individuals with refractory glaucoma. Surgical success was defined by complications, intraocular pressure, the glaucoma medication score and bleb fluid distribution determined by magnetic resonance imaging.

Here were some of the findings:
• Postoperatively, significant reductions were found in IOP at 23 months and medication score at 27 months (p<0.05).
• Although a transient hypertensive phase was observed in seven patients, it was controlled without ocular massage and additional surgery.
• A patient who had suprachoroidal hemorrhage during surgery lost light perception seven months after the surgery, and another patient developed hypotony at three and four months postop, which spontaneously improved during subsequent exams.
• MRI showed that the double bleb layer adjacent to the endplate tended to have more bleb fluid on the conjunctival side than on the scleral side facing the outlet (n=8; one to 29 months after surgery).

Researchers concluded that pars plana AGV implantation using the upside-down technique was a relatively effective alternative to manage inadequate IOP control in individuals with refractory glaucoma.

SOURCE: Masuda Y, Saito Y, Oki T, et al. Surgical technique for pars plana ahmed glaucoma valve implantation in advanced glaucoma: The upside-down technique. J Glaucoma 2021; Jan 13. [Epub ahead of print].



Anti-VEGF Dosing and Expected Acuity Outcome at One Year

Investigators determined dose-response characteristics of the anti-vascular endothelial growth factor agents ranibizumab and aflibercept in neovascular age-related macular degeneration using published randomized trials and observational series.

They conducted a literature review of published series from 2006 to 2018, as determined from electronic searches of PubMed and the Cochrane Library. Data extracted included treatment strategy, frequency and first-year visual acuity response. Monthly or bimonthly treatment schedules were classified as Fixed; pro re nata studies were noted as PRN; treat-and-extend cases were classified as TE; and when no strategy was listed, the studies were noted as Variable.

Of 2,062 citations, 96 eligible studies provided 120 data points of dose frequency vs. visual acuity change in year one of treatment. Here were some of the findings:
• The dose response curve was nonlinear, but a log transform of the number of injections per year yielded a linear relationship defined by the expression, letters of improvement= -6.66 + 15.7*log (Number of Injections Year 1).
• After accounting for the number of injections, neither the drug used (ranibizumab or aflibercept) nor the strategy employed (Fixed, PRN, TE or Variable) were significant predictors of acuity change.
• Studies using the PRN approach had the lowest number of injections and the worst acuity improvements as a treatment strategy.

Investigators wrote that there appeared to be a predictable, mathematically defined relationship between dose frequency and visual acuity change at one year in nAMD. They added that the performance of current treatment efforts, as suggested by reported series and Medicare claims data, appeared to be substandard.

SOURCE: Spaide RF. Anti-vascular endothelial growth factor dosing and expected acuity outcome at 1 year. Retina 2021; Jan 11. [Epub ahead of print].


Factors Predicting Repeat DMEK Failure

Scientists evaluated repeat Descemet’s membrane endothelial keratoplasty success rates and identified risk factors for re-DMEK failure, as part of a retrospective case series in an institutional setting.

A chart review was performed, including all eyes with primary DMEK failure who underwent re-DMEK between 2013 to 2019 at the Toronto Western Hospital and Kensington Eye Institute (Toronto), and who had at least six months of follow-up.

Of 590 consecutive DMEK surgeries, 40 eyes (6.7 percent) were identified as having had a secondary DMEK surgery after failure of primary DMEK. Here were some of the findings:
• Etiologies for primary DMEK were: Fuchs’ endothelial corneal dystrophy (FECD) (32.5 percent); pseudophakic bullous keratopathy (35 percent); prior failed graft (27.5 percent); and other indications (5 percent).
• Fifty-five percent of the cohort was categorized as having complicated anterior segments, including the following eyes:
   o 11 with previous glaucoma surgery;
   o seven with post-PKP;
   o four with post-DSAEK;
   o three with peripheral anterior synechia,
   o three with previous pars plana vitrectomy,
   o two with aphakia;    
   o one with aniridia;
   o one with anterior chamber intraocular lens; and
   o one with iris-fixated IOL.
• Re-DMEK failure was documented in 12 eyes (30 percent) of the cohort.
• The risk factor for re-DMEK failure was presence of “complicated anterior segment” (p=0.01, OR=17.0 [CI, 1.92 to150.85]), with a 50 percent re-DMEK failure rate in this subgroup

Scientists reported that re-DMEK was a viable option for cases of primary DMEK failure, especially for eyes with FECD as an indication for primary DMEK without other ocular morbidities. However, they added that eyes categorized with complicated anterior segments had high re-DMEK failure rates.

SOURCE: Eyal Cohen E, Mimouni M, Sorkin N, et al. Risk factors for repeat descemet membrane endothelial keratoplasty graft failure short title: Factors predicting repeat DMEK failure. Am J Ophthalmol 2021; Jan 22. [Epub ahead of print].


Comparing the Effects of Anti-VEGF Treatments on PED in AMD

The aim of this study was to compare structural and visual outcomes of treatment-naive neovascular age-related macular degeneration patients with significant pigment epithelial detachment, treated with ranibizumab and aflibercept.

This retrospective case series included 33 treatment-naive patients treated with ranibizumab and 25 treated with aflibercept. The patients were followed with pro re nata (PRN) after first three intravitreal injections. LogMAR visual acuity, PED height and radius on spectral-domain optical coherence tomography findings were compared.

Here were some of the findings:
• For ranibizumab and aflibercept groups, respectively:
   o baseline mean PED height was 270.39 ±114.14 µm and 315.24 ±115.8 µm (p=0.14).
   o baseline mean PED radius was 2,063.64 ±942.75 µm and 1,958.88 ±452.22 µm (p=0.61); and
   o baseline BCVA was 1.16 ±0.73 and 1.09 ±0.69 (p=0.73).
• In the aflibercept group, a statistically significant decrease was found in PED height at the first, third and 12th months.
• The decrease in PED radius was greater in the aflibercept group, though not statistically significantly.
• Visual acuity was better in the aflibercept group at all three months, though not statistically significantly.

Researchers found the maximum improvement was seen at the third month, and final visual acuity and parameters of PED were better in the aflibercept group. They added that both drugs had efficacy for choroidal neovascularization, but suggested that, in cases with significant PED, aflibercept could be considered first-line treatment.

SOURCE: Ulusoy MO, Kal A, Yilmaz G. Comparison of the effects of anti-vascular endothelial growth factor treatments on pigment epithelial detachment in age-related macular degeneration. Int Ophthalmol 2021; Jan. 22. [Epub ahead of print].




Complimentary CME Education Videos


Industry News


Genentech announced announced topline results from two identically designed global Phase III studies, TENAYA and LUCERNE, evaluating its investigational bispecific antibody, faricimab, in people with neovascular age-related macular degeneration. Both studies met their primary endpoint and showed that people receiving faricimab injections at fixed intervals of up to every 16 weeks achieved visual acuity outcomes that were non-inferior to those receiving aflibercept injections every eight weeks, the company says. Nearly half (45 percent) of people in both studies were treated with faricimab every 16 weeks during the first year. Read more.



Nanoscope Receives Orphan Drug Designation for Gene Therapy

Nanoscope Therapeutics received FDA Orphan Drug Designation for its gene therapy-based treatment of Stargardt’s disease. The therapy uses light-sensitive molecules to re-sensitize the retina toward ambient light level. Nanoscope’s pipeline includes optogenetics-based retinal regeneration therapy for vision restoration in patients with retinitis pigmentosa, Stargardt’s disease and dry age-related macular degeneration. Read more.



MeiraGTx’s AAV-CNGA3 Granted FDA Fast Track Designation for Achromatopsia Treatment

MeiraGTx announced the FDA granted Fast Track designation to its AAV-CNGA3 gene therapy product candidate for the treatment of achromatopsia (ACHM), caused by mutations in the CNGA3 gene. AAV-CNGA3 is an investigational gene therapy treatment designed to restore cone function, delivered to the cone receptors at the back of the eye via subretinal injection. Read more.

Nonprofit Partners with Genetics Company to Treat Blinding Diseases

In an effort to help medical researchers develop new treatments for blinding eye diseases, Advancing Sight Network and Kailos Genetics created the OcularGeneScreen, a genetic screening panel to be used with eye tissue from post-mortem eye donors, to help determine which genes are associated with eye diseases such as age-related macular degeneration, glaucoma and Fuchs’ Dystrophy. Read more.







Eyedaptic Augmented Reality Visual Aid Granted Patent

Eyedaptic announced it was granted the first of nine pending patents and that it launched an Equity Crowdfunding Campaign to introduce its visual aid solution to stakeholders in the eye-care and technology communities. Eyedaptic develops visual-aid software that it says enables a more complete field of vision and simulates natural vision for people with central vision disorders. Learn more.



J&J Vision Names Menziuso as Worldwide President for Vision Care

Johnson & Johnson Vision announced that Peter Menziuso is assuming the role of worldwide president, Vision Care, for Johnson & Johnson Vision immediately. Peter replaces Swami Raote, who retired at the end of 2020, after a 29-year tenure with Johnson & Johnson. Menziuso most recently served as president, Cardiovascular & Metabolism, Janssen, where he led the organization in its mission to advance cardiovascular and metabolic care.











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