From the editors of Review of Ophthalmology:
JANUARY IS GLAUCOMA AWARENESS MONTH
In this issue: (click heading to view article)
Retinal Leakage Index Dynamics on Ultra-Widefield FA in Eyes Treated with Intravitreal Aflibercept for PDR: RECOVERY Study
Researchers aimed to characterize leakage indices on ultra-widefield fluorescein angiography in proliferative diabetic retinopathy treated with intravitreal aflibercept. The prospective study enrolled subjects for treatment of proliferative diabetic retinopathy randomized 1:1 to receive 2-mg intravitreal aflibercept every four weeks (2q4) or every 12 weeks (2q12).
Researchers analyzed ultra-widefield fluorescein angiography images obtained at baseline, 24 and 48 weeks using a semiautomated leakage segmentation platform. They calculated panretinal and zonal leakage indices.
Forty eyes of 40 subjects were included, and mean age was 48 ±12.1 years. Mean number of injections was 11 ±1.7 in the 2q4 arm and 4 ±0.4 in the 2q12 arm. Median baseline leakage index in the 2q4 was 5.1 percent, and median baseline leakage index in the 2q12 group was 4.3 percent (p=0.28). Here were some of the findings:
• At 24 and 48 weeks, the 2q4 group significantly improved to 1.1 percent (-79 percent, p
• At week 24, the 2q12 group demonstrated non-significant improvement (3.4 percent; -21 percent, p
=0.47); by week 48, improvement was significant (1.4 percent; -68 percent, p
• The 2q4 group resulted in lower leakage index (1.1 percent) compared with the 2q12 group at 24 weeks (3.4 percent)(p
=0.008), but by 48 weeks, leakage index was similar between both groups (1.1 percent [2q4 group] vs. 1.4 percent [2q12 group]; p
Researchers found that proliferative diabetic retinopathy treated with intravitreal aflibercept demonstrated significant leakage index reductions at one year. Monthly dosing provided more rapid reductions in leakage index compared with quarterly dosing.
Source: Babiuch AS, Wykoff CC, Srivastava SK, et al. Retinal leakage index dynamics on ultra-widefield fluorescein angiography in eyes treated with intravitreal aflibercept for proliferative diabetic retinopathy in the RECOVERY study. Retina 2020; Jan 8. [Epub ahead of print].
Private Equity in U.S. Ophthalmology & Optometry: Acquisitions from 2012 to 2019
Investigators identified temporal and geographic trends in 228 private equity-backed acquisitions of ophthalmology and optometry practices in the United States, as part of a cross-sectional study using private equity acquisition and investment data from Jan. 1, 2012, to Oct. 20, 2019.
Investigators compiled acquisition and financial investment data from six financial databases and four industry news outlets, and publicly available press releases from private equity firms or platform companies.
Main outcome measures included yearly trends in ophthalmology and optometry acquisitions including number of total acquisitions, clinical locations and providers of acquired practices, as well as subsequent sales, median holding period, geographic footprint and financing status of each platform company. Here were some of the findings:
• The 228 practices associated with 1,466 clinical locations and 2,146 ophthalmologists or optometrists were acquired by 29 private equity-backed platform companies.
• Of these acquisitions, 127 were comprehensive/multispecialty, nine were retina practices and 92 were optometry practices.
• Acquisitions increased rapidly between 2012 and 2019; 42 practices were acquired between 2012 and 2016, and then 186 were bought from 2017 to 2019.
• Financing rounds of platform companies paralleled temporal acquisition trends.
• Three platform companies, comprising 60 percent of platforms formed before 2016, were subsequently sold or recapitalized to new private equity investors by the end of the study period, with a median holding period of 3.5 years.
• Geographically, acquisitions occurred in 40 states with a majority of private equity firms developing multi-state platform companies.
• The two states with the greatest number of PE acquisitions were New York (22) and California (19).
Investigators determined that private equity-backed acquisitions of ophthalmology and optometry practices have rapidly increased since 2012, with some platform companies having already been sold or recapitalized to new investors. Further, they found that private equity-backed platform companies have developed regionally focused and multi-state models of add-on acquisitions. Investigators suggested that future research should assess the impact of private equity investment on patient, provider and practice metrics, including health outcomes, expenditures, procedural volume and staff employment.
SOURCE: Chen EM, Cox JT, Begaj T, et al. Private equity in ophthalmology and optometry: Analysis of acquisitions from 2012 to 2019 in the United States. Ophthalmology 2020; Jan 10. [Epub ahead of print].
Efficacy of a T&E Regimen with Ranibizumab in nAMD
Scientists wrote that, although the Canadian Treat-and-Extend Analysis Trial With Ranibizumab in Patients With Neovascular Age-Related Macular Disease (CANTREAT) study provided data to show noninferiority of treat-and-extend (T&E) strategies at 12 months, few data exist on 24-month T&E trials compared with monthly dosing.
Scientists compared the efficacy of ranibizumab using a T&E regimen to monthly dosing in treatment-naive patients with neovascular age-related macular degeneration after 24 months. The randomized, open-label, multicenter, noninferiority intent-to-treat trial with a margin of -5 letters in best-corrected visual acuity from baseline to 12 months between groups was conducted at 27 treatment centers in Canada. Participants included 580 individuals with treatment-naive choroidal neovascularization secondary to AMD. The study was conducted from May 8, 2013, to Aug. 28, 2018, and the researchers analyzed data between Aug. 29 and Sep. 12, 2018.
Patients with nAMD were randomized 1:1 to receive intravitreal ranibizumab 0.5 mg in either a T&E or monthly dosing regimen. Main outcomes and measures included mean change in BCVA in Early Treatment of Diabetic Retinopathy Study letters from baseline to month 24.
Of the 580 randomized individuals, 350 were women (60.3 percent) and 547 were white (94.3 percent). Mean (SD) age was 78.8 (7.8) years. By the end of month 24, 466 of the 580 randomized patients (80.3 percent) had completed the study, and participants in the T&E arm received a mean of 17.6 injections compared with 23.5 injections for the monthly arm, for a difference of 5.9 injections and visits over two years (CI, 5.4-6.5; p
<.001). Here were some of the findings:
• The mean BCVA improvement in the T&E arm (6.8 ±14.1) letters, was better than the monthly arm (6 ±12.6) letters (difference, 0.9; CI, -1.6 to 3.3; p
• In the T&E group, 25.5 percent of the group had a gain of 15 or more letters vs. 23.1 percent of the monthly treatment group (difference, 2.4 percent; CI, -6.8 to 11.6 percent; p
• In the T&E group, 6.5 percent had a loss of 15 or more letters vs. 5.8 percent of the monthly treatment group (difference, -0.7 percent; CI, -9.9 to 8.5 percent; p
Scientists wrote that a change in vision from baseline wasn’t worse with a T&E compared with a monthly regimen of ranibizumab for nAMD through 24 months, achieving clinically meaningful improvements in BCVA despite fewer injections and visits.
SOURCE: Kertes PJ, Galic IJ, Greve M, et al. Efficacy of a treat-and-extend regimen with ranibizumab in patients with neovascular age-related macular disease: A randomized clinical trial. JAMA Ophthalmol 2020; Jan 9. [Epub ahead of print].
Comparing Two Techniques for Graft Implantation in DMEK
Researchers wrote that Descemet’s membrane endothelial keratoplasty has developed into a safe procedure for replacing diseased corneal endothelium. However, they added that DMEK still results in a significant donor endothelial cell loss. In this study, researchers compared two different graft implantation techniques.
They retrospectively compared 20 individuals undergoing DMEK involving a DMEK injection cartridge to flush the graft into the anterior chamber (G-38635 single-use DMEK-Cartridge, Geuder AG; group A), with 20 individuals that had a standard lens injection cartridge (AT.Smart Cartridge, Carl Zeiss Meditec; group B) used to push the graft with a plunger. Outcome parameters were intraoperative orientation of the graft, insertion-to-attachment time, rebubbling rates and postoperative best spectacle-corrected visual acuity, endothelial cell count and central corneal thickness after 12 months. The surfaces of both cartridges were evaluated by scanning electron microscopy. Here were some of the findings:
• In group A, the insertion-to-attachment time was significantly higher (p
• Initially, the graft was oriented correctly in 40 percent of individuals in group A compared with 90 percent in group B (p=0.001).
• No differences were obtained between both groups regarding central corneal thickness, endothelial cell count or BSCVA, and rebubbling rates after 12 months.
• Scanning electron microscopy analysis demonstrated a rougher and sharper cartridge surface in group B.
Researchers concluded that significant differences between insertion techniques regarding correct graft orientation directly after graft implantation led to prolonged insertion-to-attachment time when the graft was flushed instead of pushed into the anterior chamber.
SOURCE: Siebelmann S, Janetzko M, König P, et al. Flushing versus pushing technique for graft implantation in Descemet membrane endothelial keratoplasty. Cornea 2019; Dec 20. [Epub ahead of print].
CustomFlex Artificial Iris Receives CMS Transitional Pass-through Payment Status
VEO Ophthalmics announced that the CustomFlex Artificial Iris was approved by the Centers for Medicare and Medicaid Services for transitional pass-through payment status, under the new alternative pathway for breakthrough devices, effective Jan. 1. The Healthcare Common Procedure Coding System code is: C1839 Iris prosthesis. The CustomFlex Artificial Iris is the only iris prosthesis available in the United States (FDA approved in May 2018) for use in children and adults for the treatment of iris defects resulting from congenital aniridia, acquired defects, or other conditions associated with a completely or partially missing or damaged iris.
Exonate & Janssen to Develop Retinal Vascular Disease Treatments
Exonate entered into a strategic collaboration agreement with Janssen Pharmaceuticals. Through the collaboration, Exonate will work with Janssen research and development scientists to develop an eye-drop treatment for retinal vascular diseases such as wet AMD and DME using mRNA targeted therapies. Exonate has developed small molecules that inhibit the production of pro-angiogenic vascular endothelial growth factor through the selective inhibition of serine/threonine-protein kinase (SRPK1)-mediated VEGF splicing. The agreement was facilitated by Johnson & Johnson Innovation. Read more.
MacuLogix Introduces AdaptDx Pro, Guided by “Theia”
MacuLogix announced the next generation of dark adaptation functional testing with the introduction of AdaptDx Pro, guided by “Theia.” A new headset, custom-designed and tested for patient comfort, includes all of the functionality and accuracy of the company’s table-top dark adaptometer, the company says. As a self-contained wearable headset, the AdaptDx Pro requires no darkroom or external computer, and features an artificial intelligence-driven onboard technician named Theia. After the in-office technician selects the testing protocol and places the device on the patient’s head, Theia takes over to facilitate the testing experience by using automated instructions and adaptive feedback spoken directly to the patient. Theia’s A.I. helps ensure consistent, reliable testing results, and frees up the technician to focus on other tasks, MacuLogix says. The system will make its debut at the SECO (booth #838) and Vision Expo East (booth #MS4733) meetings, the company says. Read more.
Improved Reimbursement for Endoscopic Cyclophotocoagulation When Combined with Cataract Surgery
Two new CPT codes improve reimbursement for endoscopic cyclophotocoagulation for the treatment of mild to moderate glaucoma when combined with cataract surgery. The CPT editorial panel created two new codes that took effect Jan. 1: 66987, previously complex cataract removal (66982) with ECP (66711); and 66988, previously routine cataract removal (66984) with ECP (66711). The reimbursement rates initially proposed by the Centers for Medicare and Medicaid Services were significantly reduced and considered insufficient by the medical community. During the public comment period in 2019, several professional ophthalmic organizations made it clear that the proposed rates didn’t adequately capture the resources that hospitals and ASCs would expend. Based on these comments and the input of medical advisors, CMS revised the ambulatory payment classification assignments.
With the new codes, the national average payment to an ambulatory surgery center (ASC) for combined cataract and ECP will be $2,393, an increase of $931. Hospital outpatient departments (HOPDs) reimbursement for the new codes will average $3,818, an increase of $1,900. In 2020, the CPT code for ECP (66711) will be used only when performing ECP as a stand-alone procedure. An increase of 5 percent and 4 percent has been allocated to HOPDs and ASCs, respectively, while physician reimbursement decreased by 22 percent.
Oyster Point’s OC-01 Nasal Spray Advances in Phase II
Oyster Point Pharma announced positive top-line results from its Phase II MYSTIC study in dry-eye disease. Results showed a statistically significant improvement in Schirmer’s scores from baseline at day 84 in both doses compared with the control, the company says. Read more.
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