From the editors of Review of Ophthalmology:
In this issue: (click heading to view article)
Prognostic Implications of Hyperreflective Crystalline Deposits in Non-neovascular AMD
Researchers explored patterns of disease progression in non-neovascular age-related macular degeneration associated with hyperreflective crystalline deposits (HCDs) in the subretinal pigment epithelium-basal laminar space, as part of a retrospective medical records review of multimodal imaging; longitudinal eye-tracked, near-infrared reflectance (NIR); and optical coherence tomography spanning ≥2 years.
NIR/OCT images were analyzed with ImageJ software to identify HCD morphology and location. Researchers reviewed associated macular complications from HCD detection to the most recent follow-up, using NIR/OCT. Thirty-three eyes with HCDs from 33 individuals (mean age: 72 ±7.5 years) had 46.7 months (CI, 33.7, 59.6) of serial eye-tracked NIR/OCT follow-up. Here are some of the findings:
• Baseline best-corrected visual acuity was 0.44 logMAR (Snellen equivalent 20/55).
• At a mean of 11.3 months (3.1, 19.6) after HCD detection, 31/33 (93.9 percent) eyes had developed macular complications including de novo areas of complete retinal pigment epithelium and outer retinal atrophy (cRORA) in 21/33 (64 percent) eyes, enlargement of preexisting cRORA in 4/33 (12 percent) eyes and incident macular neovascularization in 3/33 (9 percent) eyes.
• Movement and clearance of HCDs in 9/33 (27 percent) eyes was associated with enlargement of preexisting cRORA (r=0.44, p=
0.02). BCVA at the last follow-up visit had decreased to 0.72 logMAR (20/105).
Researchers concluded that eyes with non-neovascular AMD demonstrating HCDs were at risk for vision loss due to macular complications, particularly when movement and clearance of such structures appeared on multimodal imaging. They added that HCD reflectivity and dynamism might be amenable to automated recognition and analysis to assess cellular activity related to drusen end stages.
SOURCE: Fragiotta S, Fernández-Avellaneda P, Breazzano MP, et al. The fate and prognostic implications of hyperreflective crystalline deposits in nonneovascular age-related macular degeneration. Invest Ophthalmol Vis Sci. 2019;60:8:3100-9.
Pseudodrusen and the Development of Late AMD in the Fellow Eye
Investigators evaluated whether the development of late age-related macular degeneration in fellow eyes with pseudodrusen was associated with the pseudodrusen pattern in individuals with unilateral exudative AMD, as part of a retrospective, observational study.
A retrospective analysis was performed on 73 individuals with unilateral exudative AMD showing pseudodrusen in their fellow eyes. Eyes were classified according to pseudodrusen pattern, which was determined based on maximum pseudodrusen ribbon length. Here were some of the findings:
- During the mean follow-up period of 35.5 ±18.6 months, 21 (28.8 percent) eyes developed late AMD.
- Among these eyes, 15 (71 percent) developed exudative AMD and six (29 percent) developed geographic atrophy.
- Development of late AMD in fellow eyes occurred with significantly more prevalence in individuals showing a ribbon-dominant type pseudodrusen pattern in their fellow eye than dot-dominant type (p=0.0005, log-rank test).
- Cox-regression analysis revealed that development of late AMD in fellow eyes was associated with:
- the presence of ribbon-dominant pseudodrusen in fellow eyes (HR, 4.15; CI, 1.59 to 10.8);
- older age (HR, 1.10; CI, 1.03 to 1.17);
- a history of smoking (HR, 17.2; CI, 1.11 to 263);
- presence of large soft drusen in the fellow eye (HR, 5.49; CI, 1.29 to 21.1); and
- retinal angiomatous proliferation (HR, 5.02; CI, 1.90 to 13.2).
Investigators determined that fellow eyes with ribbon-dominant pseudodrusen in individuals with unilateral exudative AMD were likely to develop late AMD.
SOURCE: Sakurada Y, Sugiyama A, Kikushima W, et al. Pseudodrusen pattern and development of late age-related macular degeneration in the fellow eye of the unilateral case. Jpn J Ophthalmol 2019; Jul 2. [Epub ahead of print].
Treatment of Severe Keratoconus Hydrops
Scientists reported on the successful management of severe corneal hydrops by corneal optical coherence tomography guidance and intracameral application of eye platelet-rich plasma (E-PRP) in a case of a patient with Down syndrome.
A 36-year-old woman with Down syndrome presented with acute vision loss, pain, photophobia and corneal edema in the left eye. Clinical examination revealed keratoconus in the right eye and extreme keratoconus with severe corneal hydrops in the left eye. Anterior segment OCT (MS-39, Costruzione Strumenti Oftalmici) showed intrastromal cystic fluid collection, and a ruptured and detached Descemet’s membrane.
After medical treatment and intracameral sulfur hexafluoride injection failed, a sterile 0.3 mL of E-PRP was injected into the anterior chamber. Clinical and anatomical improvements began from the first postoperative day, and corneal edema totally resolved at one week. Postoperatively, no significant side effects were noted with the exception of an early, transient, moderate (28 mmHg) intraocular pressure peak. Anterior segment-OCT demonstrated dramatic normalization in corneal morphology with total disappearance of fluid in the cystic intracorneal space, closure of the DM rupture and DM reattachment. The individual was stable during the six-month follow-up.
Scientists wrote that, in this case, intraocular E-PRP was a promising, apparently safe and effective treatment option for the management of corneal hydrops when conventional approaches failed. They added that this was the first case in the literature to describe the OCT appearance of corneal hydrops and intracameral use of E-PRP for the resolution of DM rupture in acute corneal hydrops.
SOURCE: Alio JL, Toprak Ibrahim, Rodriguez AE. Treatment of severe keratoconus hydrops with intracameral platelet-rich plasma injection. Cornea 2019; Jun 22. [Epub ahead of print].
Longitudinal Analysis of Bruch’s Membrane Opening Morphometry in Myopic Glaucoma
Researchers assessed longitudinal changes in morphological characteristics of the Bruch’s membrane opening in control and glaucomatous subjects.
They followed 53 myopic eyes (17 controls, six suspects, 20 with stable glaucoma and 10 with progressing glaucoma) for an average of 4.2 ±1.4 years, and imaged them at baseline and two follow-up appointments using a 1,060 nm swept-source optical coherence tomography system. They segmented Bruch’s membrane and Bruch’s membrane opening, and measured four morphometric BMO parameters (area, ellipse ratio, non-planarity and depth). Here are some of the findings:
• There were no significant changes in the BMO area or ellipse ratio for all groups.
• BMO non-planarity was shown to increase in the glaucoma groups.
• BMO depth relative to BM increased in all groups except the suspects (controls: 8.1 µm/y, p=
0.0001; stable glaucoma group: 3.5 µm/y, p=
0.0001; progressing glaucoma group: 14 µm/y, p=
• In linear mixed-model analysis, axial length was positively associated with the BMO area in all groups except for progressing glaucoma and with BMO non-planarity in stable glaucoma; it wasn’t a significant factor in of BMO parameter slopes in the ANCOVA analysis of slopes.
Researchers reported that, longitudinally, Bruch’s membrane opening increased in non-planarity in glaucoma eyes, and its axial position relative to Bruch’s membrane became more posterior in control and glaucoma eyes.
Source: Bhalla M, Heisler M, Han S, et al. Longitudinal analysis of Bruch’s membrane opening morphometry in myopic glaucoma. J Glaucoma 2019; July 19. [Epub ahead of print].
B+L Introduces 23-Gauge Bi-Blade Dual Port Vitrectomy Cutter for Stellaris Elite
Bausch + Lomb introduced a 23-gauge Bi-Blade dual port vitrectomy cutter for the Stellaris Elite vision enhancement system. The new probe joins the available 25- and 27-gauge Bi-Blade cutters as the most efficient option in the Bi-Blade portfolio, the company says. All Bi-Blade cutters are designed to double effective cut rates to increase flow and efficiency compared with single-port probes by cutting in both forward and backward directions, enabling two cuts per cycle. To see the probes firsthand, visit the Bausch + Lomb booth (#606) at the American Society of Retina Specialists meeting (July 26-30) in Chicago. Read more.
Genentech/Roche Complete Enrollment in Archway
Genentech and Roche completed patient enrollment in the Phase III Archway clinical trial investigating the Port Delivery System with ranibizumab in people with wet age-related macular degeneration. The refillable eye implant is designed to continuously release a customized formulation of ranibizumab over a period of months. Archway, the first Phase III trial with a device used for the continuous delivery of an anti-VEGF therapy, is a multicenter, randomized, visual assessor-masked, active-comparator controlled trial evaluating the PDS for the treatment of wet AMD using fixed interval dosing. Read more.
Allegro to Present Results of Phase II Risuteganib Intermediate Dry AMD Study
Allegro Ophthalmics announced that the results of its Phase II study evaluating risuteganib (Luminate) for the treatment of intermediate nonexudative age-related macular degeneration would be presented during the American Society of Retina Specialists Annual Meeting (July 26-30) in Chicago. In June, Allegro announced topline results of the Phase II intermediate dry AMD clinical trial, which met its primary endpoint with 48 percent of individuals in the risuteganib arm at week 28 gaining ≥8 letters from baseline, compared with 7 percent of individuals in the sham group at week 12 (p=0.013). Read more.
IVERIC bio Advances LCA10 Minigene Program & Expands Orphan Gene Therapy Portfolio
IVERIC bio entered into an agreement with the University of Massachusetts Medical School for rights to develop and commercialize mutation-independent, novel adeno-associated virus gene therapy product candidates for the treatment of Leber’s Congenital Amaurosis type 10 due to CEP290 gene mutations. The company also entered into a sponsored research agreement with UMass Medical School for rights to develop and commercialize novel AAV gene therapy product candidates using a mutation-independent minigene therapy approach for the treatment of vision loss in USH2A-related inherited retinal diseases. Read more.
The Centers for Medicare and Medicaid Services assigned J-codes to two ophthalmic drugs recently. J-codes are reimbursement codes used by commercial insurance plans, Medicare, Medicare Advantage, and other government payers for Medicare Part B drugs that are administered by a physician. Claims submission and payment are standardized with a J-code, facilitating and streamlining billing and reimbursement.
First, CMS confirmed its preliminary decision to assign a permanent product-specific J-code for Omeros’ Omidria (phenylephrine and ketorolac intraocular solution) 1% / 0.3%. Omidria is a commercial drug that can be used during cataract surgery to prevent miosis and reduce postoperative pain, which the company says can improve patient outcomes and safety. The new J-code for Omidria—J1097—will become effective October 1, 2019. Read more.
Around the same time, EyePoint Pharmaceuticals announced that CMS had assigned a specific and permanent reimbursement J-code, J7314, for its product Yutiq (fluocinolone acetonide intravitreal implant) 0.18 mg. Yutiq is a three-year micro-insert for chronic, non-infectious uveitis affecting the posterior segment. The new code will also become effective on October 1st. Read more.
Augmented-reality Contact Lens Advances in Studies
Innovega, a developer of lightweight wearable displays that feature a high-resolution, panoramic-field-of-view system for medical, consumer, and industrial applications, announced that it had received Institutional Review Board approval of a protocol for single exposure of its iOptik contact lens and prototype display eyewear simultaneously for up to six hours, allowing augmented reality experts to report their observations when viewing media from the company’s eMacula near-eye display eyewear. The company’s patented platform, eMacula, includes eyewear and the iOptik high-resolution smart contact lenses that work together to deliver broad application in medicine, augmented reality (AR) and virtual reality (VR), Innovega says. The company expects results from this and other IRB-approved feasibility studies to be available in the fourth quarter of 2019. Read more.
New Products from Alcon
Alcon introduced the Hypervit Dual Blade Vitrectomy Probe–the latest evolution of the Ultravit probes and newest addition to the company's Constellation Vision System—at the American Society of Retina Specialists meeting in Chicago. Alcon says Hypervit enables surgeons to modify duty cycle and control flow independent of vacuum and cut rate, creating stable, closed-system intraocular surgeries. Hypervit will be available as both a 25+ and 27+ gauge probe. The probe will be commercially available later this year
The company is also introducing its next generation Ngenuity 3D Visualization System with Datafusion. Alcon says this latest version of the 3D viewing system provides real-time feedback from the Constellation Vision System through the "surgical parameter overlay," delivering an "immersive surgical experience."
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