Review of Ophthalmology Online



Vol. 23, #15  •   Monday, April 18, 2022


In this Issue:




Anti-VEGF Therapy for ME Secondary to HRVO vs. CRVO: SCORE2 Report 18

Intravitreal anti-vascular endothelial growth factor injections are commonly used to treat eyes with macular edema secondary to hemiretinal vein occlusion or central retinal vein occlusion. Information on whether differences exist in outcomes after anti-VEGF therapy can help guide treatment for the different disease types.

Investigators compared baseline characteristics, treatment burden and outcomes of macular edema treatment in participants with HRVO with those of participants with CRVO.

This post hoc outcome analysis from the Study of Comparative Treatments for Retinal Vein Occlusion 2 randomized clinical trial included 362 participants with macular edema caused by HRVO or CRVO, treated at 66 U.S. sites. Randomization began in September 2014, and the last month 24 follow-up visit occurred in February 2018. Data were analyzed from April 2020 to May 2021.

Eyes were initially randomized to six monthly intravitreal injections of aflibercept or bevacizumab, and were treated according to protocol between months six and 12 depending on six-month outcome. After month 12, patients were treated per investigator discretion and observed through month 60.

The main outcome and measure was mean visual acuity letter score (VALS).

Of 362 included patients, 157 (43.4 percent) were female, and the mean age was 68.9 ±12 years. Outcome data were analyzed up to month 24 owing to substantial missing data at later visits. Here are some of the findings:
• A significantly greater proportion of participants with HRVO than those with CRVO were black (37 vs. 11 percent).
• Treatment rates between months 12 to 23 were 0.36 (CI, 0.32 to 0.40) injections per month for patients with CRVO and 0.28 (CI, 0.19 to 0.36) for patients with HRVO (p=.11).
• The mean VALS from months one to 24 of an HRVO study eye exceeded that of a CRVO study eye by 5.5 (CI, 1.5 to 9.5; p=.01), consistent with the magnitude of the VALS difference between eyes with CRVO and HRVO at baseline.
• Eyes with CRVO presented at baseline with more macular edema than eyes with HRVO (difference in central subfield thickness [CST], 86 μm; CI, 48 to 124; p<.001), with no difference in CST between the groups throughout months one to 24.

Investigators found black race was more prevalent among participants with HRVO than CRVO and that no differences were observed in the frequency of treatments for macular edema between eyes with CRVO and HRVO, although eyes with CRVO presented with worse visual acuity and more macular edema on average than eyes with HRVO. The magnitude of VALS improvement, central retinal thickness in response to anti-VEGF therapy and treatment burden were similar between the groups, investigators added.

SOURCE: Scott IU, Oden NL, VanVeldhuisen PC, et al.; SCORE2 Study Investigator Group. Baseline characteristics and outcomes after anti-vascular endothelial growth factor therapy for macular edema in participants with hemiretinal vein occlusion compared with participants with central retinal vein occlusion: Study of comparative treatments for retinal vein occlusion 2 (SCORE2) Report 18. JAMA Ophthalmol 2022; Mar 24. [Epub ahead of print].





Five-year Safety and Efficacy of F-DMEK

The purpose of this study was to evaluate five-year safety and efficacy outcomes of femtosecond-enabled Descemet membrane endothelial keratoplasty (F-DMEK) in patients with Fuchs' endothelial dystrophy.

The retrospective study included patients with Fuchs’ and cataract who underwent either F-DMEK (16 eyes of 15 patients) or manual DMEK (M-DMEK) (42 eyes of 37 patients) combined with cataract extraction. Outcome measures included visual acuity, graft detachment, graft survival and endothelial cell loss.

Here are some of the findings:
• The average follow-up for F-DMEK was 57.1 ±12.4 months and for M-DMEK was 58.5 ±17.3 months (p=0.757).
• The rates of primary failure (0 vs. 9.5 percent, p=0.567), secondary failure (0 percent for both) and graft rejection (0 vs. 7.1 percent, p=0.533) didn’t differ significantly between the groups.
• Improvement in best spectacle-corrected visual acuity was similar in F-DMEK and M-DMEK (0.32 ±0.27 logMAR and 0.35 ±0.44 logMAR, respectively, p=0.165) and continued at two, three, four and five years, and at the last follow-up.
• The rates of graft detachment and rebubbling were significantly lower at follow-up, with 6.25 percent in F-DMEK and 33.3 percent in M-DMEK (p=0.035).
• Cell-loss rates were lower in F-DMEK compared with M-DMEK throughout the follow-up, significantly so up to two years with a difference of:
   o 8.6 percent at one year (p=0.023);
   o 11.8 percent at two years (p=0.021);
   o 7.6 percent at three years (p=0.088);
   o 5.8 percent at four years (p=0.256);
   o 13.6 percent at five years (p=0.169); and
   o 7.1 percent at the final follow-up (p=0.341).

Scientists reported that F-DMEK had an excellent safety and efficacy profile which was maintained over five years of follow-up. They suggested that lower endothelial cell-loss rates in F-DMEK compared with M-DMEK may help extend the duration of graft survival.

SOURCE: Sorkin N, Gouvea L, Din N, et al. Five-year safety and efficacy of femtosecond laser-assisted Descemet membrane endothelial keratoplasty. Cornea 2022; Mar 18. [Epub ahead of print].





Corneal Hysteresis and Rates of Neuroretinal Rim Change in Glaucoma

Researchers evaluated the impact of corneal hysteresis (CH) as a risk factor for progressive neuroretinal rim loss in glaucoma, as measured by spectral-domain optical coherence tomography measurement of Bruch's membrane opening minimum rim width (MRW). One of the authors is a consultant for Reichert, maker of the Ocular Response Analyzer, which was used to measure CH in the study.

This prospective observational cohort study included a study group of 118 eyes of 70 glaucoma subjects. Average follow-up time for the cohort was 3.9 ±1.3 years with an average of 6.4 ±2.0 SD-OCT tests, ranging from four to 12.

CH measurements were acquired at baseline. Linear mixed models were used to investigate the relationship between rates of MRW loss and baseline CH. Multivariable analyses adjusted for other predictive factors for progression included mean intraocular pressure, central corneal thickness (CCT), age, race and baseline disease severity.

Main outcome measures included the effects of CH on rates of MRW change over time.

Here are some of the findings:
• CH had a significant effect on rates of MRW progression over time.
• Each 1 mmHg lower CH was associated with -0.38 μm/year faster MRW loss (CI, -0.70 to -0.06; p=0.019) after adjustment for other predictive factors.
• Mean IOP was significantly associated with progression, with -0.35 μm/year (CI, -0.47 to -0.23) faster MRW change for each 1 mmHg higher pressure (p<0.001).
• In the analysis of predictive strength, mean IOP was the strongest predictive factor (R2=23 percent), followed by CH (R2=14 percent) and baseline disease severity (R2=6 percent).
• CCT explained only 3 percent of the variability in slopes of change in global MRW.

Researchers wrote that lower CH measurements were associated with faster loss of neuroretinal rim in glaucoma, as measured by MRW.

SOURCE: Jammal AA, Medeiros FA. Corneal hysteresis and rates of neuroretinal rim change in glaucoma. Ophthalmol Glaucoma 2022; Mar 21. [Epub ahead of print].


Complimentary CME Education Videos



Efficacy of Tocilizumab for Non-infectious Uveitis in STOP-Uveitis Study

Researchers used a composite endpoint scoring system to assess efficacy of two doses of the intravenous arthritis drug tocilizumab (TCZ) in eyes with non-infectious uveitis. They used data from the STOP-Uveitis Study (a Phase II multicenter, randomized interventional clinical trial), in which monthly intravenous infusions of 4 mg/kg (Group 1) or 8 mg/kg (Group 2) TCZ until month six were administered.

Efficacy was ascertained by a composite endpoint scoring system consisting of: (1) visual acuity; (2) intraocular inflammation; (3) central retinal thickness; (4) posterior segment inflammation on fluorescein angiography; and (5) steroid taper. Each component of the grading system was graded as: (+1) improvement; (−1) worsening; or (0) no change, based on specific criteria. The clinical response was classified as positive (improvement in at least one parameter and worsening in none), negative (worsening of any parameter) or stable (neither improvement nor worsening of any parameter). The percentage achieving various clinical responses was compared between groups.

Thirty-seven patients were analyzed. Here are some of the findings:
• At month six, 31 (83.8 percent) subjects demonstrated a positive clinical response (Group 1=14 [77.8 percent] and Group 2=17 [89.5 percent]).
• Three (8.1 percent) subjects (all Group 1) met the criteria for treatment failure, whereas three (8.1 percent) subjects showed a stable clinical response (Group 1=1 and Group 2=2).
• The difference in clinical responses between study groups wasn’t significant (p>0.05).

Researchers found that both doses of intravenous TCZ were effective in improving or maintaining stability in patients using the composite endpoint scoring system. They found that such a composite scoring system may be a better measure to assess efficacy outcomes vs. only vitreous haze or other single outcome measures.

SOURCE: Hassan M, Sadiq MA, Ormaechea MS, et al. Utilisation of composite endpoint outcome to assess efficacy of tocilizumab for non-infectious uveitis in the STOP-Uveitis Study. Br J Ophthalmol 2022; Apr 4. [Epub ahead of print].




Industry News

Alcon Launches VR Training

Alcon recently introduced the Fidelis Virtual Reality Ophthalmic Surgical Simulator, a portable VR tool for cataract surgeons-in-training. As part of the company’s Alcon Experience Academy, an initiative by which surgeons can train with the company’s products, the VR simulator offers a “high-fidelity, virtual operating room environment with haptic feedback to simulate the look and feel of cataract surgery.” The simulator can be used from any location around the world with the ability to invite others to join virtual instruction and training sessions, Alcon says. Read more.

Phospholine Iodide Gets Orphan Drug Designation

Fera pharmaceuticals' drug Phospholine Iodide (echothiophate iodide for ophthalmic solution) was just granted Orphan Drug Designation by the FDA for the treatment of Stargardt disease. Read more.

New Clareon Line of IOLs Available

Alcon recently launched its Clareon family of IOLs The company says that Clareon uses the company’s newest, most advanced IOL material, to “deliver consistent visual outcomes and exceptional clarity.” Alcon says this clarity is born from a glistening-free IOL material that has very low levels of haze and subsurface nanoglistenings.
Clareon Monofocal, Clareon PanOptix, Clareon PanOptix Toric, Clareon Vivity and Clareon Vivity Toric IOLs are now available in the United States. The lenses are inserted using the reusable Clareon Monarch IV Delivery System. The company says that the Clareon Monofocal is also available in the next-generation automated, single-use delivery system, AutonoMe. Read more.

Annexon Completes Enrollment for ARCHER Phase II Trial

Annexon completed enrollment for the Phase II ARCHER trial evaluating its anti-C1q candidate, ANX007, in patients with geographic atrophy. Annexon plans to report topline data on the primary endpoint in the first half of 2023 following 12 months of treatment, with full data expected after the six-month off-treatment period. Read more.

Adverum Proceeds with IND Amendment for ADVM-022 Phase II Trial

Per its request, Adverum Biotechnologies received FDA feedback related to its planned Phase II trial of ADVM-022 in wet age-related macular degeneration. Adverum requested the FDA’s input to ensure a complete filing of its Investigational New Drug amendment for the trial, designed to evaluate the 2 X 1011 vg/eye dose and a new lower 6 X 1010 vg/eye dose of ADVM-022, along with new enhanced prophylactic steroid regimens, including local steroids and a combination of local and systemic steroids. Read more.

Prevent Blindness Announces Rising Visionary Award Recipients

Prevent Blindness announced the co-recipients of the third annual Rising Visionary Award as Marissa K. Shoji, MD, Bascom Palmer Eye Institute, and Hursuong Vongsachang, MPH, Johns Hopkins University School of Medicine, Johns Hopkins Bloomberg School of Public Health. Read more.


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