Review of Ophthalmology Online



Vol. 22, #11  •   Monday, March 15, 2021


In this Issue:


Effect of Medically Lowering IOP on Peripapillary and Macular Blood Flow

Reduction of intraocular pressure by latanoprost in treatment-naïve eyes is significantly correlated to an increase in vessel density at the optic nerve head, researchers wrote. They aimed to evaluate the effect of topical latanoprost on ocular microvasculature using optical coherence tomography angiography.

This prospective case-control study included 26 eyes from 18 treatment-naïve subjects in whom latanoprost 0.005% was initiated. In 10 out of the 18 subjects, medication was initiated in only one eye; contralateral untreated eyes were used as controls. OCTA (AngioVue, Optovue) was performed at baseline and ≥3 weeks after commencing treatment. Main outcome measures were changes in flow area and vessel density (VD) at the optic nerve head (ONH), radial peripapillary capillaries (RPC) and macula. Comparison between the two visits was performed using linear mixed model adjusted for inter-eye correlation and mean ocular perfusion pressure.

Here are some of the findings:
• IOP decreased by 26.1 ±11.3 percent (p<0.001) in the cases and 0.18 ±12.2 percent (p=0.63) in controls.
• Significant correlations between change in IOP and change in ONH VD (correlation coefficient [r]=-0.42; p=0.04), and between change in IOP and change in RPC VD (r=-0.48; p=0.02) were observed in the cases, while none were observed in the controls.
• When multiple testing was considered, no significant changes in flow area and VD were observed in cases and controls.

Researchers wrote that the reduction of IOP by a PGA in treatment-naïve eyes was significantly correlated with the increase in ONH VD and RPC VD. This may indicate a mechanism by which IOP reduction modulates the risk of glaucoma progression by improving ocular microperfusion.

SOURCE: Liu C, Umapathi RM, Atalay E, et al. The effect of medical lowering of intraocular pressure on peripapillary and macular blood flow as measured by optical coherence tomography angiography in treatment-naïve eyes. J Glaucoma 2021; Mar 5. [Epub ahead of print].


Impact of Baseline Characteristics on GA Progression in the FILLY Trial

Apellis Pharmaceuticals’ investigators evaluated the effect of select baseline characteristics on geographic atrophy progression in eyes receiving intravitreal pegcetacoplan or sham, as part of the company’s Phase II multicenter, randomized, single-masked, sham-controlled trial of the drug.

Patients with GA received 15 mg pegcetacoplan monthly or every other month (EOM), or sham injection monthly or EOM for 12 months. The primary efficacy endpoint was change in GA lesion size (square root) from baseline. Post hoc analysis evaluated the effects of age; gender; lesion size, focality and location (extrafoveal vs. foveal); pseudodrusen status; best-corrected visual acuity; and low luminance deficit (LLD) on GA progression at month 12.

Of 246 randomized patients, 192 with 12-month data were included in this analysis. Here are some of the findings:
• Overall mean (standard deviation) change in lesion size (mm) was 0.26 (0.17) (p<0.01), in the monthly pegcetacoplan group (n=67); 0.27 (0.27) (p<0.05) in the EOM pegcetacoplan group (n=58) group; and 0.36 (0.21) in the sham (n=67) group.
• In univariate analysis, patients with extrafoveal lesions (p<0.001), BCVA ≥20/60 (p=0.001) and larger LLD (p=0.002) had greater mean changes in lesion size.
• Multivariate analysis confirmed significant association of extrafoveal lesions (p=0.001) and larger LLD (p=0.023) with GA progression.
• Monthly and EOM pegcetacoplan significantly reduced progression (p<0.05) when controlling for these risk factors.

Investigators found that extrafoveal lesions and larger LLD were potential risk factors for GA progression. They reported that pegcetacoplan treatment significantly controlled GA progression even after accounting for these risk factors.

SOURCE: Steinle NC, Pearce I, Monés J, et al. Impact of baseline characteristics on geographic atrophy progression in the FILLY trial evaluating the complement C3 inhibitor pegcetacoplan. Am J Ophthalmol 2021; Mar 3. [Epub ahead of print].


Medication Adherence Among Patients with Corneal Diseases

While medication nonadherence is a ubiquitous problem, the adherence of patients to medications to manage corneal conditions is unknown, scientists wrote. A prospective cohort study investigated the patterns of eye-drop adherence among patients with corneal conditions.

Patients who were at least 18 years old and were taking prescription eye medications were recruited from an academic center's corneal clinic. Data collected included age, sex, total doses of eye medications and the category of primary corneal diagnosis. Participants completed adapted versions of the 12-question Adherence to Refills and Medications Scale (ARMS) and the three-question Voils' Medication Adherence Scale (VMAS). Survey data were categorized as “adherent” and “nonadherent,” and subscales were reported for reasons of nonadherence. Logistic regression analyses were used to test associations with adherence.

A total of 199 participants were surveyed from February to March 2019 (95 percent response rate). Participants were ages 19 to 93 years, with a mean age of 59 years (SD 17.8). Here are some of the findings:
• The percent of participants considered nonadherent was 72 percent by the ARMS and 33 percent by the VMAS.
• Older age was associated with higher adherence by the ARMS (OR=1.48; CI, 1.14 to 1.93; p=0.004) and by the VMAS (OR=1.24; CI, 1.04 to 1.48; p=0.012).
• Adherence wasn’t significantly associated with race, sex, education, total doses of eye medications or primary cornea diagnosis.

Scientists wrote that medication adherence was lower than expected, particularly on the ARMS scale, which asks more detailed questions. They suggested that clinicians should engage in conversations about adherence, especially with younger patients, in the absence of an anticipated clinical response.

SOURCE: Khan M, Michelson S, Newman-Casey PA, et al. Medication adherence among patients with corneal diseases. Cornea 2021; Mar 5. [Epub ahead of print].


Prognostic Significance of Multilayered PED Detachment in AMD

Researchers investigated the structure of multilayered pigment epithelial detachment (m-PED) in neovascular age-related macular degeneration, and its association with visual prognosis and the progression of fibrotic scars at 12 months.

They retrospectively analyzed 68 eyes of 63 patients with m-PED that included a prechoroidal cleft. The compartments within m-PED were divided into neovascular tissue (layer 1); a hyperreflective band (layer 2); and a prechoroidal cleft (layer 3). Clinical variables were compared between patients presenting with layer 2 and those who didn’t. Multiple regression analyses were used to find the factors related to visual outcome and fibrotic scar formation.

Here are some of the findings:
• Layer 2 was detected in 38 (55.9 percent) of 68 eyes.
• With continuous treatment, those with layer 2 showed gradual visual deterioration (p<0.001 at month 12), while those without layer 2 showed visual improvement (p<0.001 at month 12).
• In the group with layer 2, thickness significantly increased, and in those without layer 2, if it formed, it increased gradually (p=0.004 at month 12).
• In both groups, other layers significantly decreased by month 12.
• The presence of layer 2 at baseline was significantly associated with a poor visual outcome (p=0.009) and fibrotic scar formation (p=0.023).

Researchers found that multilayered pigment epithelial detachment with a hyperreflective band had a higher risk of fibrotic scar formation and was associated with a poor visual prognosis. They added that a hyperreflective band may be an early-stage precursor of a fibrotic scar.

SOURCE: Kim I, Ryu G, Sagong M. Morphological features and prognostic significance of multilayered pigment epithelium detachment in age-related macular degeneration. Br J Ophthalmol 2021; Mar 3.[Epub ahead of print.]




Industry News

Graybug Reports a Switch in Patient Dose in Phase IIb ALTISSIMO Trial

Graybug Vision provided preliminary topline data from its Phase IIb ALTISSIMO trial of GB-102, a microparticle depot formulation of sunitinib malate injected intravitreally, for the treatment of wet age-related macular degeneration. The trial was originally designed to evaluate two separate doses of GB-102, 1 mg and 2 mg, injected every six months as compared with aflibercept injected every two months. Based on the results of an interim safety analysis, the company discontinued use of the 2 mg dose was after the initial dose, and all patients were switched to 1 mg for their second dose, as the 1 mg dose performed better than the 2 mg dose overall, Graybug says. Read more.



Second Sight Gets FDA Nod for Argus 2s Retinal Prosthesis System

Second Sight Medical Products announced the FDA approved the Argus 2s Retinal Prosthesis System, a redesigned set of external hardware (glasses and video processing unit) for use in combination with previously implanted Argus II systems for the treatment of retinitis pigmentosa. Read more.



Teva Launches Generic Version of Azopt

Teva Pharmaceuticals launched the first generic version of Azopt (brinzolamide ophthalmic suspension) 1%, approved by the FDA to treat ocular hypertension and open-angle glaucoma. Read more.

Oculus Pentacam AXL Wave Receives FDA Clearance

The new Oculus Pentacam AXL Wave—which features retroillumination and a Hartman-Shack sensor for total eye wavefront and objective refraction, in addition to established functions of anterior segment tomography and optical biometry—received FDA 510(k) clearance. It incorporates reports with network compatibility and full operability of all Pentacam software and exams. The company says the measuring process is fast and patient-friendly, and a guide allows both eyes to be examined in less than five minutes. In addition, the new device comes with an overview display showing all parameters for corneal screening, IOL power selection, IOL power calculation, ICL selection and calculation, and pupil diameter under dimmed and dark conditions. Read more.



Complimentary CME Education Videos




Lutronic Vision Treats First AMD Patient in R:GEN Clinical Trial

Lutronic Vision treated the first early-stage age-related macular degeneration patient in its clinical trial evaluating the R:GENTM laser. The single-arm, open-label pilot study will enroll approximately 30 early-stage AMD patients who will be treated with R:GENTM, and evaluated at 24 and 48 weeks. Read more.

CiRC Biosciences Announces Orphan Drug Designation for RP Treatment

CiRC Biosciences announced the FDA granted Orphan Drug Designation for chemically induced photoreceptor-like cells (CiPCs) for the treatment of retinitis pigmentosa. The company is advancing pre-clinical development of CiPCs for vision restoration in advanced RP and geographic atrophy age-related macular degeneration; CiRC says its novel technology enables direct chemical transdifferentiation of fibroblasts into other cell types using a cocktail of small molecules in a chemical conversion process that takes less than two weeks. Learn more.













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