From the editors of Review of Ophthalmology:
In this issue: (click heading to view article)
Corneal Hysteresis in a Population Cohort: Results from 96,010 UK Biobank Participants
Researchers described the distribution of corneal hysteresis in a large cohort, and assessed its associated factors and possible clinical applications, as part of a cross-sectional study within a large cohort study. They analyzed CH data from 93,345 eligible participants, ages 40 to 69, in the UK Biobank cohort.
Researchers used left eye data as part of their analysis, in addition to linear regression models to evaluate associations between CH and demographic, lifestyle, ocular and systemic variables. They also used piecewise logistic regression models to explore the relationship between self-reported glaucoma and CH. Here were some of the findings:
• The mean CH was 10.6 mmHg (10.4 mmHg in males, 10.8 mmHg in females).
• After adjusting for covariables, CH was significantly negatively associated with male sex, age, Black ethnicity, self-reported glaucoma, diastolic blood pressure and height.
• CH was significantly positively associated with smoking, hyperopia, diabetes, systemic lupus erythematosus, greater deprivation (Townsend index) and Goldmann-correlated intraocular pressure (IOPg).
• Self-reported glaucoma and CH were significantly associated when CH was less than 10.1 mmHg (OR 0.86; CI, 0.79 to 0.94 per mmHg CH increase) after adjusting for covariables.
• When CH exceeded 10.1 mmHg, no significant association was found between CH and self-reported glaucoma.
Researchers found CH was significantly associated with factors including age, sex and ethnicity—factors that the scientists advised should be taken into account when interpreting CH values. In their cohort, lower CH was significantly associated with a higher prevalence of self-reported glaucoma when CH was less than 10.1 mmHg. Researchers concluded that CH might serve as a biomarker aiding glaucoma case detection.
SOURCE: Zhang B, Shweikh Y, Khawaja AP, et al. Associations with corneal hysteresis in a population cohort: Results from 96,010 UK Biobank participants. Ophthalmology 2019; July 5. [Epub ahead of print].
Pseudodrusen Pattern & Development of Late AMD in Fellow Eyes of Unilateral Cases
Investigators assessed 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.
They performed a retrospective analysis 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 of pseudodrusen pattern in their fellow eye than a 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), along with 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).
Researchers determined that individuals with unilateral exudative AMD who had fellow eyes with ribbon-dominant pseudodrusen 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].
DMEK vs. DSAEK and Penetrating Keratoplasty
Scientists compared the long-term graft survival outcomes and complications of individuals who underwent Descemet’s membrane endothelial keratoplasty, Descemet’s stripping automated endothelial keratoplasty and penetrating keratoplasty for Fuchs' corneal endothelial dystrophy and bullous keratopathy.
The retrospective, comparative cohort study included individuals with FECD and BK who underwent DMEK (121 eyes), DSAEK (423 eyes) or PK (405 eyes) in the Singapore Corneal Transplant Registry’s prospective cohort. Scientists compared the survival probabilities of the three groups using a Kaplan-Meier survival analysis. The main outcome measure was graft survival. Here were some of the findings:
• The DMEK group had the best overall cumulative graft survival of 97.4 percent, compared with DSAEK (78.4 percent) and PK (54.6 percent) (p<
• In eyes with FECD, the DMEK group had the best graft survival of 98.7 percent compared with DSAEK (96.2 percent) and PK (73.5 percent)(p=
• Graft survival in BK eyes was poor overall; however, the DMEK group still had the best graft survival of 94.7 percent compared with DSAEK (65.1 percent) and PK (47 percent, p=
• Eyes that underwent DMEK had the lowest rate of graft rejection (1.7 percent vs. DSAEK 5 percent vs. PK 14.1 percent, p<
0.001) and postoperative elevation of intraocular pressure (11.6 percent vs. DSAEK 23.6 percent vs. PK 22.5 percent, p=
Scientists determined that individuals who underwent DMEK for FECD and BK had better graft survival compared with those who underwent DSAEK and PK. They added that DMEK eyes also had significantly lower rate of graft rejection and elevated IOP compared with DSAEK and PK for the same indications.
SOURCE: Woo JH, Ang M, Htoon HM, et al. Descemet membrane endothelial keratoplasty versus Descemet stripping automated endothelial keratoplasty and penetrating keratoplasty. Am J Ophthalmol 2019; Jun 19. [Epub ahead of print].
Morphological Changes of Focal Choroidal Excavation
Scientists evaluated morphological changes of focal choroidal excavation, as part of a retrospective review of the medical records of 18 FCE individuals (25 eyes). They analyzed clinical features and images of the ocular fundus, fundus fluorescein angiography, indocyanine green angiography and spectral-domain optical coherence tomography. And they used OCT images as a major criterion to evaluate changes that occurred during follow-up.
Of 18 individuals (nine male, nine female), the mean age was 41 ±13.5 years. The follow-up period was 38.5 ±24.7 (seven to 92) months. Here were some of the findings:
• Thirteen patients were myopic.
• FCE appeared from slight pigment irregularity to yellowish white plaque.
• FFA revealed window defects corresponding to the lesions.
• Early-phase ICGA images showed hypofluorescence and medium to large choroidal blood vessels.
• Plaque- or dot-like hyperfluorescence was seen on late-phase images.
• OCT scans showed that 11 individuals had unilateral FCE, and seven patients were bilaterally affected.
• Twenty-three eyes had a single FCE, and the other two eyes had two excavations.
• FCE presented as the confirming type in 21 eyes and non-confirming type in three eyes.
• Investigators found discontinuity of the interdigitation zone, ellipsoid zone and retinal pigment epithelium/Bruch’s complex zone.
• The average subfoveal choroidal thickness was 312.06 ±66.12 μm in FCE eyes.
• During follow-up, choroidal neovascularization developed in four individuals, and retinal pigment epithelium discontinuity was aggravated in one eye.
• No remarkable changes were found in the other eyes on B scans of the OCT images, but the volume of FCE might have changed slightly.
Investigators reported that FCE, both confirming type and non-confirming type, might remain stable during a long period of time. They added that choroidal neovascularization could develop at the site of FCE.
Source: Zheng-Yu C, Lei S, Wen-Bin W. Morphological changes of focal choroidal excavation. Graefes Arch Clin Exp Ophthalmol 2019; Jul 4. [Epub ahead of print].
Clearside Enters Into License Agreement with Aura Biosciences
Clearside Biomedical announced its entry into a worldwide licensing agreement with Aura Biosciences for the use of Clearside’s Suprachoroidal Space Microinjector to deliver Aura’s proprietary drug candidates into the SCS for the potential treatment of certain ocular cancers, including choroidal melanoma. Aura is developing a novel class of therapies, viral nanoparticle conjugates, designed to selectively bind and eliminate cancer cells without damaging surrounding normal tissues. Read more.
FDA Deems Allergy Drug Application “Not Approvable”
Bausch + Lomb received a Complete Response Letter relating to shortcomings in the application for the allergic conjunctivitis drug EM-100, the rights to which B+L purchased from Eton Pharmaceuticals earlier this year. In a statement on the matter, Eton says that “no concerns were raised about the clinical data in the application, so it is not anticipated that any additional clinical work will be required.” Eton adds that a response to the FDA’s letter will be forthcoming, and that it “remains confident in the approvability of the product.”
“We believe the issues cited in the CRL can be addressed in the coming months, and we remain confident that EM-100 will be available to patients as quickly as possible,” said Sean Brynjelsen, chief executive officer of Eton Pharmaceuticals, in an official statement. Read more.
Archway Trial Completes Enrollment
Genentech and Roche have completed patient enrollment in the Phase III Archway (Clin trial number: NCT03677934) clinical trial investigating the Port Delivery System with ranibizumab (PDS) in people with wet age-related macular degeneration. The PDS is a refillable eye implant designed to continuously release a customized formulation of ranibizumab over a period of months.
The PDS allows continuous delivery of ranibizumab and thus is intended to reduce the burden of frequent eye injections by allowing people with wet AMD to go several months before needing a refill of the implant, the partners say, and to address undertreatment that could lead to vision loss.
Nicox Receives Milestone Payment from Eyevance for Zerviate
Nicox announced that it received a $3 million milestone payment from partner Eyevance Pharmaceuticals, triggered by the completion of the regulatory and manufacturing activities for the future U.S. launch of Zerviate (cetirizine ophthalmic solution) 0.24%, the first topical ocular formulation of the antihistamine cetirizine for the treatment of ocular itching associated with allergic conjunctivitis. Read more.
Ohr Pharmaceutical Gets Stockholder Nod for Merger with NeuBase
Ohr Pharmaceutical announced that all proposals related to its proposed merger with NeuBase Therapeutics were approved by Ohr’s stockholders. As previously announced, the proposed merger will create a public company under which the stockholders of NeuBase will become majority holders of the combined company. The combined company will change its name to NeuBase Therapeutics Inc., and the NASDAQ trading symbol will become “NBSE.” NeuBase says it’s focused on advancing its proprietary peptide-nucleic acid antisense oligonucleotide technology platform for the development of therapies to address severe and currently untreatable diseases caused by genetic mutations. Read more.
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