Review of Ophthalmology Online

 

 



Vol. 22, #27  •   Monday, June 28, 2021

JUNE IS FIREWORKS EYE SAFETY & CATARACT AWARENESS MONTH

In this Issue:
 
 

Trabeculectomy Plus Limited Deep Sclerectomy vs. Trabeculectomy Alone


Researchers wrote that the addition of limited deep sclerectomy to conventional trabeculectomy enhances the success rate, especially in pseudophakic eyes. As such, they evaluated the efficacy of limited deep sclerectomy in enhancing the IOP-lowering outcomes of trabeculectomy, as part of a parallel arm, single-masked, randomized controlled trial.

Sixty-eight eyes of 68 patients with moderate to advanced primary open-angle glaucoma or primary angle closure glaucoma (PACG) with pseudophakia were recruited at a tertiary eye-care center in Northern India and randomized into two groups. Thirty-five eyes in group one underwent trabeculectomy alone and 33 eyes in group two underwent trabeculectomy with LDS. All cases were augmented with low-dose subconjunctival mitomycin-C (0.1 mg/mL for one minute) in both groups.

The primary outcome measure was intraocular pressure, and success rates were calculated for IOP ≤18/15/12 mmHg and ≥5 mmHg. Secondary outcome measures included evaluation of bleb morphology, presence of intrascleral aqueous lake and supraciliary flow on ultrasound biomicroscopy.

Here are some of the findings:
• Mean postoperative IOP at 12 months was 13.4 ±1.83 mmHg in group one and 12.5 ±1.67 mm Hg in group 2 (p=0.04).
• For IOP cutoff ≤15 mmHg, absolute success was noted in 11 (31.4 percent) and 22 eyes (66.6 percent) in groups one and two, respectively (p=0.004).
• At 12 months the intrascleral lake was detected in two eyes (6 percent) in group one and nine eyes (29 percent) in group two (p=0.02).
• The supraciliary flow was detected in two eyes (6.2 percent) in group two and none in group one, at 12 months (p=0.02).
• In the Cox proportional hazard model, trabeculectomy with LDS was associated with a lower rate of failure (HR: 0.32; CI, 0.13-0.75, p=0.009).

Researchers wrote that the addition of LDS to trabeculectomy achieved lower mean IOP and higher success rates at 12 months compared to trabeculectomy alone.

SOURCE: Dada T, Sharma A, Midha N, et al. Efficacy of trabeculectomy combined with limited deep sclerectomy versus trabeculectomy alone: A randomized controlled trial. J Glaucoma 2021; Jun 4. [Epub ahead of print].

 
 

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Predominantly Persistent Subretinal Fluid in CATT


Investigators described predominantly persistent subretinal fluid in eyes receiving ranibizumab or bevacizumab for neovascular age-related macular degeneration and compared visual acuity to eyes with non-persistent SRF, as part of a cohort within the randomized Comparison of Age-related Macular Degeneration Treatments Trials (CATT) clinical trial. The participants included CATT patients assigned to a pro re nata treatment.

Reading center graders evaluated optical coherence tomography scans at baseline and monthly follow-up visits for SRF. Predominantly persistent SRF through week 12 was defined as SRF at baseline, weeks four, eight and 12. Predominantly persistent SRF through one or two years was defined as SRF in ≥80 percent of visits by year one or two, respectively. Adjusted mean VA score and VA change from baseline were compared between eyes with predominantly persistent SRF and eyes with non-persistent SRF over the same duration using linear regression models, including baseline predictors of VA and predominantly persistent intraretinal fluid (IRF).

Primary outcome measures included predominantly persistent SRF through year one, adjusted VA score and VA change, and SRF thickness at the foveal center.

Here were some of the findings:
• Among 406 eyes with baseline SRF, SRF persisted in 108 (26.6 percent) through week 12, 94 (23.2 percent) through year 1, and 77 (19 percent) through year two.
• The mean adjusted VA (letters) at year one was similar between eyes with predominantly persistent vs. non-persistent SRF by week 12, (68.1 vs. 70.2; p=0.18), year one (67.6 vs. 70.2; p=0.11), and year two (71.4 vs. 70.9; p=0.78).
• The mean adjusted change in VA at year one was similar between eyes with predominantly persistent vs. non-persistent SRF by week 12 (6.3 vs. 7.6; p=0.38), year 1 (5.5 vs. 7.8; p=0.14), and year two (8.1 vs. 7.7; p=0.78).
• Among eyes with predominantly persistent SRF through year one, SRF was absent in the foveal center in 46 (48.9 percent), thickness was 1 to 200 μm in 48 (50 percent) and >200 μm in 1 (1.1 percent) at year one.

Investigators found that eyes with predominantly persistent and non-persistent SRF through week 12, year one or year two had similar VA outcomes after adjustment for baseline covariates and persistent IRF. At the foveal center, predominantly persistent SRF was most commonly absent or present in small quantities.

SOURCE: Core JQ, Pistilli M, Daniel E, et al; Comparison of Age-related Macular Degeneration Treatments Trials (CATT) Research Group. Predominantly persistent subretinal fluid in the comparison of age-related macular degeneration treatments trials (CATT). Ophthalmol Retina 2021; Jun 11. [Epub ahead of print].
 
 

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DSAEK or DMEK for Failed Penetrating Keratoplasty


Scientists reviewed the published literature on indications and outcomes of DSAEK/DSEK and DMEK for the treatment of failed penetrating keratoplasty, as part of a systematic review and single-arm meta-analysis.

Literature searches were conducted in PubMed, Embase, Web of Science and the Cochrane Database of Systematic Reviews. Prospective and retrospective studies reporting DSAEK/DSEK or DMEK after failed penetrating keratoplasty were included. Primary outcome measures were graft survival and detachment rates, as well as postoperative visual outcomes.

A total of 25 studies with 970 individuals (989 eyes) were included, including 735 patients with 746 eyes that underwent DSAEK/DSEK surgery and 235 patients with 243 eyes which underwent DMEK surgery, all of them following a previously failed PK. There were no randomized controlled studies. Here were some of the findings:
• In all of the DSAEK-PK studies, the graft failure rate was 18 percent (10 percent, 26 percent), the detachment rate was 15 percent (9 percent, 22 percent) and the rejection rate was 7 percent (3 percent, 12 percent) by the time of the last follow-up.
• In all of the DMEK-PK studies, the graft failure rate was 14 percent (4 percent, 27 percent), the detachment rate was 42 percent (28 percent, 56 percent) and the rejection rate was 7 percent (2 percent, 16 percent).
• The mean visual acuity of the DSAEK-PK and DMEK-PK groups was 0.65 ±0.18 and 0.43 ±0.23 logMAR, respectively, at six months postoperatively.

Scientists wrote that endothelial keratoplasty for treatment of failed penetrating keratoplasty led to improved vision and graft clarity in most recipients. Though graft survival rates and rejection rates were comparable between the two groups, the DMEK-PK group showed better visual outcomes but with a higher detachment rate.

SOURCE: Wu J, Wu T, Li J, et al. DSAEK or DMEK for failed penetrating keratoplasty: a systematic review and single-arm meta-analysis. Int Ophthalmol 2021; Jun 12. [Epub ahead of print].

 
 

Incidence & Risk Factors for Macular Edema After Primary RRD Surgery


Researchers assessed the incidence of cystoid macular edema diagnosed using spectral-domain optical coherence tomography after primary rhegmatogenous retinal detachment surgery.

From April 2016 to October 2017, 150 eyes of 150 patients presenting with primary RRD were included consecutively in this prospective, single-center study. Patients with any of the following characteristics were excluded: previous vitreoretinal surgery; combined cataract surgery; preoperative presentation with any intraocular or systemic inflammatory condition; or visible macular edema or epiretinal membrane on funduscopy. SD-OCT (Spectralis, Heidelberg Engineering) was performed three and six weeks after surgery.

A total of 128 of the 150 patients completed the study. Here are some of the findings:
• A total of 107 patients (age: 61.7 ±11.5 years) showed successful retinal attachment during follow-up visits.
• The most frequent operation method was scleral buckling (54.2 percent), followed by vitrectomy (25.2 percent) and the combination of both techniques (20.6 percent).
• Postoperative SD-OCT revealed CME, neurosensory detachment and ERM in 18.7, 31.8 and 32.7 percent of all cases, respectively.
• The risk of postoperative CME was significantly elevated in patients with ERM (42.9 vs. 6.9 percent, p<0.001).
• Patients with initial detachment of the macula had more postoperative CME (26.5 vs. 11.1 percent, p=0.044).
• BCVA improvement was significantly lower in patients with CME compared to patients without six weeks after surgery for macula-on RRD.

Researchers reported that postoperative CME was a frequent complication after RRD surgery; they identified ERM and macula-off RRD as potential risk factors. They wrote that, since CME potentially delays visual recovery, postoperative follow-ups should include SD-OCT.

SOURCE: Gebler M, Pfeiffer S, Callizo J, et al. Incidence and risk factors for macular oedema after primary rhegmatogenous retinal detachment surgery: A prospective single-centre study. Acta Ophthalmol 2021; Jun 16. [Epub ahead of print].
 

 
 


Industry News


Faricimab Extends Time Between Treatments in Two Phase III studies


At this year’s American Diabetes Association Virtual 81st Scientific Sessions (June 25 to 29), Genentech is presenting primary results from two Phase III trials of its investigational bispecific antibody faricimab for diabetic macular edema. Faricimab is the first treatment that targets dual pathways to control the growth of new blood vessels, the company says. More than half of all patients who received faricimab had extended time between treatments to 16 weeks at one year—which Genentech says is the first time this level of durability has been achieved in a Phase III DME study. No new safety signals were identified. Additionally, researchers will present the design of two Port Delivery System studies, which further highlight how treatment burden may be lessened for patients.


B+L Extends Power Range for Toric Multifocal


Presbyopic patients with higher-than-usual astigmatism have had to rely on custom-fit contact lenses if they wanted to try that modality—until now. Bausch + Lomb is expanding the cyl powers on the company’s Ultra Multifocal for Astigmatism, adding powers of -2.25 D and -2.75 D to the range. According to the company, the lenses have been designed for optimal comfort, clarity and stability, along with the convenience of same-day in-office fitting during the initial exam. The cylinder power parameters now include -0.75, -1.25, -1.75, -2.25 and -2.75 D options. The other parameters remain unchanged: a sphere range of -6.00 D to +4.00 D with low- and high-add power varieties. The lenses are made of samfilcon A material, and have a base curve of 8.6 mm and a diameter of 14.5 mm. Read more.


J&J Vision’s Tecnis Synergy and Tecnis Synergy Toric II IOLs Available for Sale


Johnson & Johnson Vision announced the availability of Tecnis Synergy and Tecnis Synergy Toric II IOLs in the United States and Canada. The company says the lenses combine the best of extended-depth-of-focus and multifocal technologies to “deliver the widest range of continuous vision and the best near vision among leading PC-IOLs, without the visual gaps seen with some existing multifocal technologies.” View associated references and read more.


FDA Accepts Application for Genentech’s Port Delivery System With Ranibizumab for Treatment of Wet AMD


Genentech announced the FDA accepted its Biologics License Application, under Priority Review, for Port Delivery System with ranibizumab for the treatment of neovascular age-related macular degeneration. If approved, the company’s PDS would be an alternative to frequent injections of anti-vascular endothelial growth factor. The FDA is expected to make a decision on approval by Oct. 23. Read more.



 

Gemini Announces Initial Data From Phase IIa GEM103 Study


Gemini Therapeutics announced initial data from its Phase IIa ReGAtta study of GEM103 in patients with geographic atrophy secondary to dry AMD. The company says that GEM103 continued to be well-tolerated with no serious adverse events as of May. There were no early discontinuations due to the study drug. ReGAtta is a dose escalation trial of GEM103, intravitreally administered recombinant human complement factor H, in dry AMD patients. Read more.


Nanoscope Gets FDA Nod for IND for Phase IIb Trial


Nanoscope Therapeutics announced that it will be starting a Phase IIb clinical trial of MCO-010, an ambient-light activatable optogenetic monotherapy to restore vision in patients with advanced retinitis pigmentosa. Read more.


Clearside Announces Safety Results from Cohort 1 of OASIS


Clearside Biomedical announced positive safety results from cohort 1 of OASIS, its ongoing Phase I/IIa clinical trial of CLS-AX (axitinib injectable suspension) administered by suprachoroidal injection via Clearside’s SCS Microinjector in six patients (n=6) with neovascular age-related macular degeneration. Clearside says the primary endpoints were achieved in cohort 1, as the initial lowest planned dose of 0.03 mg CLS-AX was well-tolerated with no serious adverse events and no drug-related treatment emergent adverse events. Read more.


Gyroscope, Children’s Medical Research Institute to Develop Novel Gene Therapy Capsids


Gyroscope Therapeutics announced the company entered a research collaboration with Children’s Medical Research Institute in Australia to develop next-generation clinical capsids, the protein shells of viral vectors used to deliver gene therapies. A team of researchers from CMRI and Gyroscope will work together in the design and screening of capsid libraries to identify novel capsids for enhanced delivery of ocular gene therapies. Read more.


TelScreen Introduces EyeRes Diamond System Slit Lamp


TelScreen introduced the EyeRes Diamond System, which the company says provides slit-lamp imaging that is “closer to human eye resolution.” The digital imaging system offers a new camera with 137 million pixels per square inch, more than 3.3x the resolution of the Platinum system and within 11 percent of matching the human eye, TelScreen says. Learn more.


ScienceBased Health Ophthalmology Clinical Advisory Panel


ScienceBased Health welcomed the following experts to its ophthalmology clinical advisory panel: Kendall Donaldson, MD, MS, professor of clinical ophthalmology and medical director of Bascom Palmer Eye Institute; Preeya Gupta, MD, associate professor of ophthalmology at Duke University School of Medicine, Durham, NC; Cathleen McCabe, MD, FACS, cataract and refractive surgeon at The Eye Associates, Bradenton, Fla.; Laura M. Periman, MD, director of dry eye services and clinical research at Periman Eye Institute, Seattle; George Waring, IV, MD, FACS, founder and director of Waring Vision Institute, Mount Pleasant, S.C.; and Elizabeth Yeu, MD, partner at Virginia Eye Consultants and assistant professor of ophthalmology at Eastern Virginia School of Medicine, Norfolk, Va.


Marco Partners with Olleyes


Marco Ophthalmic entered into a distribution agreement with Olleyes, a purveyor of virtual reality ophthalmic products. Effective immediately, Marco will add the Olleyes VisuALL S VRP (Virtual reality Platform) into its existing portfolio of ophthalmic medical devices. The VisuALL is the latest commercially available virtual reality visual field analyzer that can be used in clinical practice to help detect glaucoma and to evaluate other ocular diseases. Learn more.


Optomed Offers Disposable Eye Cup


Optomed USA has made a disposable eye cup, the Optomed E-Safe, available for use with the company’s handheld fundus cameras, eliminating the need for a disinfection protocol for that aspect of the device. The eye cup is attached to the camera’s eyepiece, which rests against the patient during imaging. Learn more.


Allegro Names New Executives


Allegro Ophthalmics announced that William J. Link, PhD, was appointed chairman by the company’s board of directors and that Stephanie Yee was named vice president of finance. Dr. Link is founder and principal of Flying L. Partners and is a founder and managing director of Versant Ventures. Read more.


New Treatment for VKC Arrives


A new prescription treatment for vernal keratoconjunctivitis—a rare and recurrent form of ocular allergy sometimes referred to as “morning misery”—is now available in the United States. Verkazia (Santen), a 0.1% cyclosporine ophthalmic emulsion eye drop, received FDA approval for use in children and adults. The company says its oil-in-water cationic emulsion provides improved bioavailability of cyclosporine. In two randomized, multicenter, double-masked, vehicle-controlled clinical trials, Verkazia demonstrated improvement in corneal inflammation and ocular itching. Adverse events included eye pain (12 percent and eye pruritus (8 percent). The company notes that these events were usually transitory and occured during instillation. For information, visit santenusa.com or santen.com


 

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