Review Of Ophthalmology - August 20, 2018

Review of Ophthalmology Online

FROM THE EDITORS OF REVIEW OF OPHTHALMOLOGY:

Volume 18, Number 34

Monday, August 20, 2018

AUGUST IS CHILDREN’S EYE HEALTH/SAFETY MONTH

In this issue: (click heading to view article)

		Safety & Complications After Three Surface Ablation Techniques with Mitomycin C

		Fractal Dimension & OCTA Features of Central Macula After RRD Repair

		IOP Changes During Water Drinking Test Between Different Fluid Volumes in POAG

		Safety & Efficacy of Anti-VEGF Therapies for Neovascular AMD

		Briefly

Safety & Complications After Three Surface Ablation Techniques with Mitomycin C

Researchers evaluated the safety and spectrum of complications of three excimer laser surface ablation techniques with an intraoperative application of mitomycin C 0.02%, as part of a retrospective, non-comparative large case series.

SATs were performed on 2,757 eyes with a preoperative spherical equivalent (SE) of -4.41 ±2.44 and a Wavelight Allegretto 200 platform. Ablation zone diameters between 6 mm and 7 mm were based on mesopic pupil size. All individuals were treated with an intraoperative application of MMC for 30 to 90 seconds depending on refractive error. The mean follow-up time was >3 months (107 ±24 days). Researchers analyzed complication range and incidence and calculated the safety index.

A total of 2,757 eyes met the inclusion criteria for surface ablation; 2,573 eyes were assigned to alcohol-assisted photorefractive keratectomy—135 eyes to transepithelial photorefractive keratectomy, and 49 eyes to off-flap epithelial laser in situ keratomileusis. Overall, the safety index was 1.06 ±0.28. Haze was graded according to the Fantes scale. Haze incidence rates were highest in the TPRK group (14.81 percent) and comparably low in APRK (2.95 percent) and EpiK (4.08 percent) groups.

Researchers concluded that intraoperative topical application of MMC (0.02%) resulted in good safety and no severe side effects. However, they determined that the highest incidence of haze was observed after TPRK and added that the more frequent peripheral localization of haze might be attributed to large ablation zones and the wavefront optimized ablation profile, especially in the PTK modus of the laser platform.

SOURCE: Mehlan J, Linke SJ, Skevas C, et al. Safety and complications after three different surface ablation techniques with mitomycin C: A retrospective analysis of 2757 eyes. Graefes Arch Clin Exp Ophthalmol 2018; Jul 24. [Epub ahead of print].

Fractal Dimension & OCTA Features of Central Macula After RRD Repair

Investigators wrote that individuals with macula-off rhegmatogenous retinal detachments might have suboptimal visual recovery despite successful reattachment. They evaluated the retinal microvasculature in subjects undergoing surgery for RRD using optical coherence tomography angiography.

In this case-control study, investigators compared analyses of OCTA findings of 19 eyes of 19 individuals (15 men) who underwent RRD surgery at a tertiary institute with 19 eyes of 19 age- and sex-matched healthy subjects with no known ocular disease. OCTA scans (3 × 3 mm) were obtained at three months postoperatively and analyzed. Researchers analyzed OCTA images of individuals with RRD and control subjects for capillary density index and fractal dimensions.

The mean age for study eyes was 40.21 years and 43.73 years for control eyes. Eight eyes underwent scleral buckling alone, and 11 underwent primary vitrectomy with gas tamponade (C3F8 gas) for macula-off RRD. No eyes had re-detachment during the follow-up at three months. Mean capillary density index was 33.28 ±0.99 percent in the superficial group and 34.06 ±2.22 percent in the deep retinal plexus group, compared with 36.11 ±1.29 percent in the superficial group and 37.52 ±1.24 in the deep retinal plexus group, among controls (p<0.001). The mean fractal dimension was lower in study eyes compared with controls: 1.46 vs. 1.61 in the superficial plexus group (p<0.001) and 1.58 vs. 1.64 in the deep plexus group (p<0.001).

Investigators concluded that OCTA demonstrated significant reduction in mean capillary density index and fractal dimension in individuals after surgery for RRD. As such, they suggested that reduction in vascular perfusion and branching patterns identified using novel analysis techniques on OCTA images might provide an insight into the reasons for suboptimal visual gain after RRD surgery.

SOURCE: Agarwal A, Aggarwal K, Akella Madhuri, et al. Fractal dimension and optical coherence tomography angiography features of the central macula after repair of rhegmatogenous retinal detachments. Retina 2018; Aug. 3. [Epub ahead of print].

IOP Changes During Water Drinking Test Between Different Fluid Volumes in POAG

Scientists compared the intraocular pressure response during the water drinking test, performed with 800 ml, 1,000 ml and 10 ml/kg of bodyweight and to test its relationship with body mass index, as part of a prospective, observer-masked, observational study of treated primary open-angle glaucoma cases.

In Group I, 29 consecutive individuals with body weight ≤60 kg underwent an 800 ml fluid challenge followed by a second WDT session with 10 ml/kg of body weight no longer than four months apart. Group II included 30 consecutive individuals with bodyweight >60 kg who underwent a 1,000 ml fluid challenge followed by an 800 ml test no longer than four months apart. IOP was measured before (baseline) and after water ingestion every 15 minutes for 45 minutes.

In Group I, no significant difference was found in baseline or peak IOP between 800 ml (p=0.12) and 10 ml/kg (p= 0.56) of bodyweight. However, 10 ml/kg tended to lead to consistently lower IOP values and a biased response in eyes with higher IOP. In Group II, no significant difference was found in baseline or peak IOP between 800 ml (p=0.26) and 1,000 ml (p=0.72) tests. No biased response was observed in this group. No significant association between IOP peak and BMI with 800 ml (p=0.18), 10 ml/kg (p=0.29) or 1,000 ml (p=0.34).

Scientists found overall good agreement between WDT results with different fluid volumes. They wrote that BMI didn’t affect the IOP response to the volume loads tested in this study.

SOURCE: Susanna CN, Susanna R, Hatanaka M, et al. Comparison of intraocular pressure changes during the water drinking test between different fluid volumes in patients with primary open angle glaucoma. J Glaucoma 2018; July 31. [Epub ahead of print].

Safety & Efficacy of Anti-VEGF Therapies for Neovascular AMD

Researchers reviewed the evidence on the safety and efficacy of anti-vascular endothelial growth factor therapies to treat neovascular age-related macular degeneration, via a literature search of the PubMed and Cochrane Library databases last reviewed February 2017.

Combined searches, limited to studies published in English, yielded 191 citations, 28 of which were selected because they were clinical trials deemed clinically relevant for the Ophthalmic Technology Assessment Committee Retina/Vitreous Panel to review in full. The panel methodologist then assigned a level of evidence rating to each study.

Sixteen of 28 citations provided level I evidence supporting the use of anti-VEGF agents for neovascular AMD, including intravitreal ranibizumab, aflibercept and bevacizumab. Eight studies provided level II evidence, and four provided level III evidence (only level I studies were included in the assessment). Long-term follow-up data on the efficacy of ranibizumab and bevacizumab (≥5 years) was available; however, researchers noted that this data is biased by some incomplete follow-ups.

Researchers determined that their literature review indicated that intravitreal injection of anti-VEGF therapy was safe and effective for nAMD over two years—the period for which data is available. They added that further research would be needed to evaluate the long-term safety and comparative efficacy of these agents.

SOURCE: Bakri SJ, Thorne JE, Ho AC, et al. Safety and efficacy of anti-vascular endothelial growth factor therapies for neovascular age-related macular degeneration. Ophthalmology 2018; Aug 2. [Epub ahead of print].

Ivantis Gets FDA Nod for Hydrus Microstent Device for MIGS
Ivantis received U.S. FDA approval for the Hydrus Microstent, a microinvasive glaucoma surgery device used to treat individuals with mild to moderate primary open-angle glaucoma in conjunction with cataract surgery. The approval is based on the HORIZON Trial, which included 556 mild to moderate glaucoma patients undergoing cataract surgery, randomized to either receive cataract surgery plus the Hydrus Microstent (treatment) or cataract surgery alone (control). More than three-quarters (77.2 percent) of individuals in the Hydrus Microstent group achieved a statistically significant decrease (≥20 percent reduction in unmedicated intraocular pressure) at 24-months postop compared with 57.8 percent in the cataract surgery alone group. Read more.

Sun Pharma Receives FDA Approval for CEQUA to Treat DED
Sun Pharma received approval for CEQUA (cyclosporine ophthalmic solution) 0.09%, from the U.S. FDA. CEQUA is indicated to increase tear production in individuals with keratoconjunctivitis sicca. Sun says that CEQUA provides the highest FDA-approved concentration of cyclosporine A and is the first approved CsA product to incorporate a nanomicellar technology that enables the CsA molecule to overcome solubility challenges, penetrate the eye’s aqueous layer and prevent release of the active lipophilic molecule prior to penetration. Read more.

MeiraGTx AAV-CNGA3 Receives FDA Orphan Drug Designation
MeiraGTx Holdings announced that the FDA granted orphan drug designation for its AAV-CNGA3 gene therapy product candidate for the treatment of achromatopsia caused by mutations in the CNGA3 gene. AAV-CNGA3 is an investigational gene therapy treatment delivered to the cone receptors via subretinal injection and designed to restore cone function. In June 2018, the European Medicines Agency’s Committee for Orphan Medicinal Products issued a positive opinion recommending orphan medicinal product designation for AAV-CNGA3 for the treatment of ACHM. Read more.

FDA Approves EYLEA Injection sBLA in Wet AMD
Regeneron recently announced that the U.S. FDA has approved a supplemental Biologics License Application (sBLA) for EYLEA (aflibercept) Injection in patients with wet age-related macular degeneration. The sBLA was based on second-year data from the Phase III VIEW 1 and 2 trials in which patients with wet AMD were treated with a modified 12-week dosing schedule (doses given at least every 12 weeks, and additional doses as needed). These data are now included in the updated Eylea label. Read more.

Review of Ophthalmology^® Online is published by the Review Group, a Division of Jobson Medical Information LLC (JMI), 11 Campus Boulevard, Newtown Square, PA 19073.

To subscribe to other JMI newsletters or to manage your subscription, click here.

To change your email address, reply to this email. Write "change of address" in the subject line. Make sure to provide us with your old and new address.

To ensure delivery, please be sure to add reviewophth@jobsonmail.com to your address book or safe senders list.

Click here if you do not want to receive future emails from Review of Ophthalmology Online.

Advertising: For information on advertising in this e-mail newsletter or other creative advertising opportunities with Review of Ophthalmology, please contact sales managers James Henne or Michele Barrett.

News: To submit news or contact the editor, send an e-mail, or FAX your news to 610.492.1049