Review of Ophthalmology Online



Vol. 22, #48  •   Monday, November 22, 2021


In this Issue:


A message from Review’s Chief Medical Editor, Mark H. Blecher, MD: To Party or Not to Party

One of the perennial discussions this time of year at work is whether there will be an office party. As physicians, we’re frequently in charge of that decision, either as senior managers or, less frequently these days, physician owners. Are they a good thing? Is this a good way to spend practice dollars? You can look at having a holiday party as simply a practice perk at years end, in the same category as an end-of-year bonus, or you can look at it as something else: An opportunity to show a different side to your coworkers, a more human side. When I was in private practice, we had a long history of having a holiday party and invited spouses. It was always a good time, a team-building exercise of sorts, but with liquor. When we would ask around to see what other practices were doing, we were surprised that few of them had a party. I felt it was a missed opportunity to show our more relaxed and human side to a staff that often only saw us as intense and driven (this is something we should do on a daily basis, and kudos to you if you do). By the time you read this, the window to plan holiday festivities with your staff may have closed. If you do have a celebration, I hope you take the opportunity to be an engaged and gracious host and coworker. If you don’t, then another opportunity and a new year presents itself. Let them see that both you and they are not just cogs in the machine of medicine.

Mark H. Blecher, MD
Chief Medical Editor
Review of Ophthalmology




Choroidal Vascularity Index in Pseudoexfoliative Glaucoma

Researchers evaluated the choroidal vascular involvement in pseudoexfoliative glaucoma by applying the choroidal vascularity index (CVI) to optic coherence tomography images.

Seventy-eight eyes from 40 subjects were included the study. Group one included healthy eyes (n=20), group two eyes with pseudoexfoliation (n=16) and group three eyes with PEXG (n=42). OCT imaging of macular and peripapillary regions and retinal nerve fiber layer analyses were performed. CVI was calculated using ImageJ software.

The mean age was 64.89 ±5.8 years in group one, 71.2 ±7.8 years in group two, and 68.24 ±7.4 years in group three (p=0.046). Here are some of the findings:
• No significant differences between the groups in terms of sex (p=0.777) were found.
• In the macula, mean CVI rates were:
   o 66.97 ±1.9 percent in group one;
   o 64.23 ±1.2 percent in group two; and
   o 64.63 ±1.6 percent in group three.
• In the peripapillary areas, mean CVI rates were:
   o 67.04 ±1.5 percent in group one;
   o 65.20 ±1.5 percent in group two;
   o 64.14 ±2.1 percent in group three
   o (group one vs. group two and three, p=0.000; group two vs. group three, p>0.05).
• The decrease in average RNFL thickness was statistically significant in group three compared to groups one and two.

Researchers found that CVI may be used to assess choroidal vascular changes in ocular diseases since it could be decreased in PEX and PEXG, indicating ocular vascular involvement in the pseudoexfoliative process.

SOURCE: Karslioglu MZ, Kesim C, Yucel O, et al. Choroidal vascularity index in pseudoexfoliative glaucoma. Int Ophthalmol 2021;41:12:4197-208.


Persistent Hyper-transmission Defects Detected on En Face SS-OCT & Formation of GA

Investigators sought to determine if persistent hyper-transmission defects (hyperTDs)—shown to have a greatest linear dimension (GLD) ≥250 µm on en face swept-source OCT images—serve as a stand-alone early biomarker for the future formation of geographic atrophy.

The post-hoc cohort study using a subgroup of a prospective study included patients with intermediate age-related macular degeneration.

All subjects underwent 6 × 6mm SS-OCT raster scans at baseline and during their follow-up period. En face images were generated using a slab with segmentation boundaries positioned 64 to 400 µm beneath Bruch's membrane. Two graders independently evaluated all en face structural images for the presence of hyperTDs with a GLD ≥250 µm and GA.

A total of 190 eyes were included with a mean follow up of 31 (SD: 13.2) months. Here are some of the findings:
• At baseline, 31 eyes (16 percent) had at least one hyperTD ≥250 µm, and 13 eyes (42 percent) progressed to GA.
• In eyes without a hyperTD ≥250 µm at baseline, 42 (26 percent) developed hyperTDs ≥250 µm during their follow-up and 11 (7 percent) progressed to GA.
• At the last available follow-up visit, 25 eyes (13 percent) progressed to GA and of them, 24 had a prior hyperTD ≥250 µm detected before GA formed.
• A time-dependent Cox-survival regression analysis estimated an eightyfold (CI, 10.7 to 614, p<0.001) increased risk of developing GA once a hyperTD ≥250 µm appeared.

Investigators found that persistent hyperTDs detected on en face OCT images were shown to serve as an early stand-alone OCT biomarker for the future formation of GA.

SOURCE: Laiginhas R, Shi Y, Shen M, et al. Persistent hyper-transmission defects detected on en face swept source OCT images predict the formation of geographic atrophy in AMD. Am J Ophthalmol 2021; Nov 12. [Epub ahead of print].


Corneal Endothelial Cell Damage After Scleral Fixation of IOL Surgery

Scientists analyzed corneal endothelial cell damage after scleral fixation of intraocular lens (SFIOL) surgery, as part of a retrospective study.

Medical records of consecutive eyes undergoing SFIOL surgery performed by a single surgeon were reviewed between January 2011 and June 2019. The patients were classified into three groups according to surgical methods:
• Group I, re-fixating the existing intraocular lens or fixating a new IOL in an aphakic eye;
• Group II, removing an existing IOL and fixating a new one; and
• Group III, phacoemulsification and fixating a new IOL simultaneously.
Scientists compared preoperative and postoperative specular microscopy (SM) status among the three groups.

Ninety-four eyes were included: 34 eyes in Group I, 39 in Group II and 21 in Group III. The endothelial cell density (ECD) loss in Group I was 1.5 percent, less than the ECD loss of 14.3 percent (p<0.001) in Group II and 15.4 percent (p=0.005) in Group III. In no eye was there an ECD decrease to <1,000/mm2 following the surgical procedure.

Scientists wrote that ECD loss was related to IOL removal or phacoemulsification rather than SFIOL surgery. They added that SFIOL surgery using the existing IOL is preferred in eyes with low ECD and a dislocated IOL.

SOURCE: Jo YJ, Lee JS, Byon IS, et al. Corneal endothelial cell damage after scleral fixation of intraocular lens surgery. Jpn J Ophthalmol 2021; Nov 9. [Epub ahead of print].


Complimentary CME Education Videos



Correlation of Photoreceptor Integrity with Retinal Vessel Density & Choriocapillaris in DR Eyes

Researchers evaluated the correlation of foveal photoreceptor integrity with the vessel density of the retina and choriocapillaris using swept-source optical coherence tomography angiography in eyes with diabetic retinopathy.

They retrospectively reviewed subjects with DR who underwent OCTA using swept-source OCT (Triton, Topcon). In addition, they:
• analyzed the area of the foveal avascular zone (FAZ), vessel densities of the superficial capillary plexus (SCP), deep capillary plexus (DCP) and choriocapillaris;
• measured the length of the lateral extent of ellipsoid zone (EZ) disruption, central subfield thickness and subfoveal choroidal thickness; and
• analyzed factors closely associated with the length of EZ disruption.

A total of 159 eyes with DR, and 30 healthy control eyes were included in this study. In all eyes, the lengths of EZ disruption were positively correlated with the FAZ area (p=0.009). However, they were negatively correlated with the parafoveal vessel density of the SCP (p=0.049), the foveal vessel density of DCP (p=0.003) and that of the choriocapillaris (p=0.036).

Researchers determined that the size of the FAZ and ischemia at the DCP may play an important role in maintaining foveal photoreceptor integrity in eyes with DR. They added that future studies were needed to reveal the correlation between EZ disruption and the VD of the choriocapillaris, given the issue of OCTA artifacts, such as projection and shadowing.

SOURCE: Kim JT, Park EJ. Correlation of photoreceptor integrity with retinal vessel density and choriocapillaris in eyes with diabetic retinopathy. Retina 2021 Nov 2. [Epub ahead of print].




Industry News

Alcon Surgical Planning System Debuts

Alcon recently released its Smart Solutions platform, starting with its Smart Cataract System. Using the software, surgeons and their staff can enter data once, and have it carried forward throughout the office, from EHR systems to diagnostic equipment and surgical devices. The application connects data systems and most diagnostic devices, including the Argos Biometer with Image Guidance, with Alcon’s cataract surgical equipment, including the LenSx Femtosecond Laser and LuxOR Revalia Ophthalmic Microscope, as well as commonly used microscopes and devices from other ophthalmic manufacturers. The company says by connecting biometry instruments with other medical records, surgical planning will be expedited. Alcon says entering the data only once will help eliminate transcription errors. SMART Solutions makes use of the open, cloud-based infrastructure and services of Philips HealthSuite, built on Amazon Web Services, to enable surgeons to aggregate, organize and analyze all relevant data within a single, integrated application “designed for security and remote planning.” Alcon is installing the system in several additional customers in the United States through the end of the year, and plans a broader rollout of Smart Cataract in 2022. Read more.

Apellis Plans to Submit NDA in 2022 for Pegcetacoplan for GA

Apellis Pharmaceuticals received written correspondence from the FDA that reinforces the company’s plans to submit a New Drug Application for intravitreal pegcetacoplan for geographic atrophy secondary to age-related macular degeneration. The NDA will be supported by efficacy and safety data from the Phase III DERBY and OAKS studies and the Phase II FILLY study. In the written feedback, the FDA stated that it doesn’t make a distinction between phases, provided a clinical trial is adequate and well-controlled, and that all three studies appear to be adequate and well-controlled. Based on this feedback, Apellis remains on track to submit an NDA in the first half of 2022. Read more.

Oculis Begins Phase III Study for Topical Eye Drop Treatment for DME

Oculis announced the first patients were dosed in its Phase III DIAMOND trial evaluating the efficacy and safety of OCS-01 in diabetic macular edema. OCS-01 is a novel, high concentration, preservative free, topical formulation of dexamethasone. OCS-01 has been shown to improve visual acuity and reduce central macular thickness in DME patients compared to vehicle and demonstrated a promising safety profile in the 144-patient Phase IIb (DX-211) trial, the company says. Read more.

Outlook Presents NORSE TWO Phase III Safety and Efficacy Data for ONS-5010 / Lytenava (bevacizumab-vikg)

Outlook Therapeutics presented pivotal safety and efficacy data from the Phase III NORSE TWO trial for ONS-5010, an investigational ophthalmic formulation of bevacizumab for use in wet age-related macular degeneration and other retinal indications, at the American Academy of Ophthalmology annual meeting’s Retina Subspecialty Day in New Orleans. The trial met both primary and secondary endpoints, including:
• 41.7 percent (p=0.0052) ONS-5010 subjects gained ≥15 letters of vision;
• 56.5 percent (p=0.0016) ONS-5010 subjects gained ≥10 letters of vision;
• 68.5 percent (p=0.0116) ONS-5010 subjects gained ≥5 letters of vision; and
• ONS-5010 subjects gained 11.2 letters (p=0.0043) in BCVA.
Results also demonstrated that ONS-5010 ophthalmic bevacizumab had a strong safety profile, the company says. Read more.

Ivantis Shares New Hydrus Microstent Data

Ivantis, developer of the Hydrus Microstent, a minimally invasive glaucoma surgery device intended to lower eye pressure for open-angle glaucoma patients, announced new data from its five-year HORIZON pivotal trial showing the Hydrus Microstent lowered the rate of visual field loss by 47 percent vs. cataract surgery alone. The preliminary findings were presented at the AAO annual meeting. Ivantis is to become part of Alcon in the first quarter of 2022. Read more.

EyePoint Reports Interim Data from Phase I DAVIO Trial

EyePoint Pharmaceuticals announced positive six-month interim data from the DAVIO Phase I clinical trial of EYP-1901, a bioerodible sustained delivery intravitreal anti-vascular endothelial growth factor treatment targeting wet age-related macular degeneration, at the AAO annual meeting’s Retina Subspecialty Day. Data uncovered no reports of ocular serious adverse events (SAEs), drug-related systemic SAEs; or AEs such as vitreous floaters, endophthalmitis, retinal detachment, implant migration in the anterior chamber, retinal vasculitis or posterior segment inflammation, the company says. Read more.

Regenxbio Presents Data from RGX-314 Trials in Wet AMD & DR

Regenxbio announced “additional positive interim data” from the ongoing Phase II AAVIATE trial and the ongoing Phase II ALTITUDE trial of RGX-314 using in-office suprachoroidal delivery for the treatment of wet age-related macular degeneration and diabetic retinopathy without center-involved diabetic macular edema, respectively. The results were presented at the AAO annual meeting. As of November 4, RGX-314 was reported to be well-tolerated across 50 patients dosed in cohorts one to three. Four serious adverse events reported in four patients were considered not related to RGX-314. Read more.

jCyte Identifies Biomarker

jCyte says that its Phase IIb study has found that retinitis pigmentosa patients with a baseline central visual field diameter greater than 20 degrees had a profound response to the company’s jCell treatment. Data comparing the response of a single 6 million cell intravitreal injection of jCell vs. sham revealed that RP patients with a central VF diameter >20 degrees had a statistically significant BCVA change from baseline at 12 months of 15.6 letters (p=0.029). Read more.

Bausch + Lomb Recycles

Bausch + Lomb announced its One by One and Biotrue Eye Care Recycling programs have recycled a total of 41,358,603 million units, or 248,516 pounds, of used contact lens, eye- and lens-care materials. The programs are made possible through a collaboration with TerraCycle. Read more.

OcuTerra Raises $35 Million Series B Financing

OcuTerra Therapeutics announced the close of a $35 million Series B financing. Proceeds will support the “DR-EAM” Phase II study of OTT166 in patients with moderate to severe non-proliferative and mild proliferative diabetic retinopathy. Read more.







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