EW Weekly, March 15, 2019
- Roclatan approved for IOP reduction in patients with open angle glaucoma
- DEXYCU launched commercially for postop inflammation
- Two large Phase 3 studies initiated in wet AMD for faricimab
- Special hydrogel contact lens could help treat corneal melting
- Study: Association found between dry eye disease and migraines
- First patient dosing for Usher syndrome type 2 completed in Phase 1/2 STELLAR trial
Roclatan approved for IOP reduction in patients with open angle glaucoma
The U.S. FDA has approved Roclatan (netarsudil/latanoprost ophthalmic solution, Aerie Pharmaceuticals) to lower elevated IOP in patients with open angle glaucoma or ocular hypertension, according to a company press release. Roclatan is a drop used once a day; its active ingredient is Rhopressa, a first-in-class Rho kinase inhibitor made by the company and designed to target the trabecular meshwork. The Roclatan approval was based on data from MERCURY 1 and MERCURY 2, which were Phase 3 registration trials. Aerie expects to launch Roclatan in the U.S. in the second quarter of this year.
DEXYCU launched commercially for postop inflammation
EyePoint Pharmaceuticals has commercially launched DEXYCU (dexamethasone intraocular suspension) 9% in the U.S. It is the first and only U.S. FDA-approved intraocular steroid to treat postoperative inflammation and is administered as a single dose at the end of cataract surgery, according to an EyePoint press release. DEXYCU has a J-code from the Centers for Medicare and Medicaid Services (J1095).
Two large Phase 3 studies initiated in wet AMD for faricimab
Roche and Genentech have started two worldwide Phase 3 trials for wet age-related macular degeneration (AMD) that will focus on the bispecific molecule faricimab. Faricimab is the first bispecific antibody designed to treat retinal eye diseases that simultaneously binds to and inactivates angiopoietin-2 and vascular endothelial growth factor A. The Phase 3 TENAYA and LUCERNE multicenter, randomized, double-masked, active comparator-controlled trials will include almost 1,300 patients in total. Patients will be randomized for faricimab dosed every 16 weeks or aflibercept dosed every 8 weeks. The best corrected visual acuity at week 48 compared with baseline will be the primary endpoint for both studies. Faricimab is already under investigation for diabetic macular edema.
Special hydrogel contact lens could help treat corneal melting
Researchers at the University of New Hampshire have designed a hydrogel that may eventually be made into a contact lens to help treat corneal melting, according to a university press release. The hydrogel deactivates harmful enzymes by removing thezinc ions. Research has been done both in vitro and ex vivo, the latter on extracted corneal tissue. There is a pending patent for this.
Study: Association found between dry eye disease and migraines
Patients with migraines are more likely to have comorbid dry eye disease compared with the general population, reported Omar Ismail, BS, and coresearchers. Their population-based, case-control study included 72,969 adult patients from University of North Carolina-affiliated healthcare facilities. Among the patients, 7.3% had a diagnosis of migraine headache, and 13.2% had a diagnosis of dry eye disease. The odds of having dry eye disease given a diagnosis of migraines was 1.72 (95% CI, 1.60-1.85) times higher than for patients without migraines.
First patient dosing for Usher syndrome type 2 completed in Phase 1/2 STELLAR trial
The first patient has been dosed in the Phase 1/2 STELLAR trial for QR-421a (ProQR Therapeutics) in patients with Usher syndrome type 2 or non-syndromic retinitis pigmentosa, the company reported. Interim study results are expected to be announced in the middle of this year.
Research briefs
- Among participants in a cross-sectional study, those with Alzheimer's disease had significantly reduced macular vessel density, perfusion density, and macular ganglion cell-inner plexiform layer thickness compared with those who had mild cognitive impairment and cognitively intact controls, reported Stephen Yoon, BS, and coresearchers. Their study included 70 eyes from 39 participants with Alzheimer's disease, 72 eyes from 37 participants with mild cognitive impairment, and 254 eyes from 133 control participants. All participants were imaged with the CIRRUS HD-500 with AngioPlex (Carl Zeiss Meditec) and had a cognitive evaluation with the Mini-Mental State Examination. Changes in the retinal microvasculature may mirror small vessel cerebrovascular changes in Alzheimer's, the researchers concluded. The study is published in Ophthalmology Retina.
- Patients with exfoliation syndrome may have a higher risk for a diagnosis of chronic obstructive pulmonary disease (COPD) compared with others, reported Samuel Taylor, BS, and coresearchers in their case-case and case-control comparison. Their research focused on 2,943 patients with exfoliation syndrome, 20,589 patients with COPD, and 162 patients with both disorders, all of whom were identified from Utah Population Database-linked medical records. Researchers selected and matched controls by sex and birth year to patients in a 5:1 ratio. The risk of a COPD diagnosis was increased in those with exfoliation syndrome, especially in tobacco users. Patients with COPD and controls with no COPD did not differ in their risk for an exfoliation syndrome diagnosis. Patients with COPD and exfoliation syndrome had a significantly better survival rate than patients with COPD and no exfoliation syndrome history. The study is published in Ophthalmology Glaucoma.
- In a retrospective, interventional case series, Descemet's membrane endothelial keratoplasty (DMEK) gave patients with a glaucoma drainage device acceptable clinical outcomes, reported Rénuka Birbaland coresearchers. However, a glaucoma drainage device may lower graft survival times and may pose a risk for more frequent regrafting, they added. The study focused on the clinical outcomes of 23 DMEK procedures for bullous keratopathy (52%), failed previous transplant (39%), or Fuchs' endothelial corneal dystrophy (9%) in 20 eyes (19 patients). All eyes had a glaucoma drainage device. Best corrected visual acuity (BCVA), endothelial cell density, postop complications, and graft survival were the main outcome measures. There was an 89% cumulative graft success rate at 1 year postop. Also at 1 year, the BCVA improved to 2 or more Snellen lines in 73% of eyes and remained stable in 27%. The donor endothelial cell density lowered by 37%, 60%, and 71% at 1, 6, and 12 months, respectively. Complications at up to 2 years postop included pupillary block in one eye, visually significant graft detachment that required rebubbling in five eyes, allograft rejection in two eyes, secondary graft failure in two eyes, and cataract in one of three phakic eyes. Two eyes required rekeratoplasty. The study is published in the American Journal of Ophthalmology.
- Mechanical and transepithelial PRK with a large optical zone provided effective and safe outcomes to correct low myopia without differences in visual acuity and refractive outcomes between procedures, reported Ikhyun Jun, MD, and coresearchers. Their retrospective, comparative case series focused on outcomes, vector parameters, and aberrations between mechanical PRK and transepithelial PRK in eyes with low myopia. There was a total of 84 eyes (84 patients) with myopia of 2 D or less who were treated with mechanical (41 eyes) or transepithelial (43 eyes) PRK, with application of a large optical zone. There was a comparable mean uncorrected distance visual acuity of -0.12 D and -0.15 D for the mechanical and transepithelial PRK groups, respectively, at 6 months. Safety and efficacy indices, vector parameters, and aberrometric values also were comparable. Corneal total root mean square higher order aberrations and coma were significantly lower after treatment in both groups. Spherical aberrations significantly lowered after transepithelial PRK. The research appears in the Journal of Cataract & Refractive Surgery.
- The IS-100 Ophthalmic Unit (Topcon Medical Systems) was launched to the export market. It will replace the existing IS-600N model, which has been discontinued.
- Carl Zeiss Meditec received 510(k) clearance from the U.S. FDA for the CIRRUS HD-OCT platform, which expands the capabilities of its Anterior Segment Premier Module to include epithelial thickness mapping.
This issue of EyeWorld Weekly Update was edited by Amy Goldenberg and Vanessa Caceres.
EyeWorld Weekly Update (ISSN 1089-0319), a digital publication of the American Society of Cataract and Refractive Surgery and the American Society of Ophthalmic Administrators, is published every Friday, distributed by email, and posted live on Friday.
Medical Editors: Eric Donnenfeld, MD, chief medical editor; Rosa Braga-Mele, MD, cataract editor; Clara Chan, MD, cornea editor; Nathan Radcliffe, MD, glaucoma editor; and Vance Thompson, MD, refractive editor.
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