EyeWorld Weekly Update, October 20, 2017

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October 20, 2017
Volume 23 , Number 37

Court rules against Allergan on cyclosporine patents

The U.S. District Court for the Eastern District of Texas ruled against Allergan (Dublin, Ireland) on Monday, finding four patents for Restasis (cyclosporine ophthalmic emulsion, 0.05%) invalid. Allergan will appeal the ruling, according to a company press release. The patents are set to expire in 2024. Mylan NV (Canonsburg, Pennsylvania) and Teva Pharmaceuticals (Israel) are two of the companies working on generic versions of cyclosporine, but they have not yet received federal approval, according to a Wall Street Journal article. Last month, Allergan sold the patents for Restasis to a Native American tribe to try to protect them from a separate challenge before the U.S. Patent and Trademark office.

FDA gives favorable votes for netarsudil for glaucoma

The U.S. Food and Drug Administration's (FDA) Dermatologic and Ophthalmic Drugs Advisory Committee had a favorable vote for netarsudil ophthalmic solution 0.02% (Rhopressa, Aerie Pharmaceuticals, Irvine, California) last week. On the question of whether clinical trials support the efficacy of netarsudil to reduce elevated IOP in patients with open-angle glaucoma or ocular hypertension, there were 10 yes votes and 0 no votes. When voting on whether the efficacy of netarsudil outweighed the safety risks identified with it, there were nine yes votes and one no vote. There also was a general discussion regarding the draft product labeling proposed by the FDA. The FDA's goal date to take action under the Prescription Drug User Free Act is Feb. 28, 2018.

Study: DMEK benefits outweigh DSEK

A review of published literature on the safety and outcomes of Descemet membrane endothelial keratoplasty (DMEK) to treat corneal endothelial dysfunction supports the procedure as safe and effective. Led by Sophie X. Deng, MD, researchers included 47 articles in their assessment and found that the mean best corrected visual acuity (BCVA) ranged from 20/21 to 20/31. At 6 months, 37.6% to 85% of eyes had a BCVA of 20/25 or better. At 6 months, the mean endothelial cell loss was 33%. Partial graft detachment requiring air injection was the most common complication, followed by IOP elevation. Graft survival rates ranged from 92% to 100%. For Descemet stripping endothelial keratoplasty (DSEK), the BCVA ranged from 20/34 to 20/66 at 9 months. Graft detachment, endothelial rejection, and primary graft failure were the most common complications; mean endothelial cell loss was 37% at 6 months. Researchers concluded that DMEK was superior, induced less refractive error and had similar surgical risks and endothelial cell loss compared with DSEK. The research appears in Ophthalmology.

ASCRS member-exclusive webinar on Wednesday, October 25

Register now for the upcoming webinar, "Maximizing Refractive Cataract Surgery Outcomes in the Post-Op Period," which will take place on Wednesday, October 25 at 9 p.m. EDT. Sponsored by the ASCRS Young Eye Surgeons Clinical Committee, the webinar will discuss how to best manage the dissatisfied patient and how to make happy patients even happier. Join moderator Naveen Rao, MD, facilitator Julie Schallhorn, MD, and panelists Neda Shamie, MD, Sumit "Sam" Garg, MD, and Michael Greenwood, MD, for an interactive, case-based discussion about achieving successful postoperative results. The webinar will also cover the following topics:
  • Practical approaches to postop residual astigmatism and refractive error
  • Addressing postoperative ocular surface issues
  • Managing the (un)happy patient: strategies for success
Panelists will also take questions from the audience. Register now for what is sure to be a lively and informative event!

RESEARCH BRIEFS

  • Although it is possible to not schedule postop visits for patients with uncomplicated cataract surgery, patients with comorbidities should receive customized planning of their postop follow-ups. That was the conclusion of Inger Westborg, MD, and coresearchers in their prospective case study, which focused on safety when the standard routine after cataract surgery is no planned postop visit. The study included 1,249 patients (1,115 in the study group and 134 in a control group), all of whom had cataract surgery in a 1-year period. The study group had uneventful cataract surgery and no planned postop visit. The control group had a planned postop visit. There were no significant differences in demographics, postop corrected distance visual acuity, frequency of planned visits for ocular comorbidity, or postop patient-initiated contacts. Nine percent of patients in the study group initiated a postop contact, from which 26% had a scheduled visit. Visual disturbance, redness or chafing, pain, or anxiety were the causes of the patient-initiated contacts. There were no reports of missed adverse events. Preoperative counseling is also important if no postop visits are planned, the authors concluded. The research appears in the Journal of Cataract & Refractive Surgery.
  • Higher and more variable tear osmolarity measurements were found in individuals with symptomatic dry eye that was not yet clinically significant, according to Priya M. Mathews, MD, MPH, and coresearchers. They obtained tear osmolarity and other quantitative tear film osmolarity information in 131 patients with clinically significant dry eye, 52 patients with symptoms-only dry eye, and 42 controls. Although tear osmolarity varied across groups, those with clinically significant dry eye had the highest tear osmolarity (312.0 mOsm/L). Control patients had the lowest (305.6 mOsm/L0), and patients with symptoms-only dry eye fell in between those two groups (307.4 mOsm/L). Higher tear osmolarity was associated with higher scores on the Ocular Surface Disease Index discomfort subscores and higher corneal and conjunctival staining scores. Higher or more variable tear film osmolarity may precede clinical findings, the researchers concluded. The study appears in Cornea.
  • In a case-control study with 206,931 cataract cases, serotonin reuptake inhibitors (SSRIs) were not associated with an increased risk of cataract, according to Susan S. Jick, DSc, and coresearchers. Their research was based on previous associations between SSRIs and cataract risk. The study publication came from the UK-based Clinical Practice Research Datalink and included patients with first-time cataract who were age 40 and older between 1995 and 2015 and an equal number of matched cataract-free controls. Researchers also performed regression analysis adjusted for body mass index, smoking, hypertension, diabetes, and systemic steroid use. Long-term use of SSRIs (20 prescriptions or more) was not associated with an increased cataract risk. However, there was a subset of patients ages 40 to 64 years who were long-term SSRI users and had a slightly increased risk compared with nonusers. The latter should be explored in further studies, the researchers reported. The study appears in Ophthalmology.
  • Aqueous humor could potentially serve as a surrogate tumor biopsy when retinoblastoma tumor tissue is not available, a recently published study reported. Jesse L. Berry, MD, and coresearchers included six aqueous humor samples from three retinoblastoma eyes-two after primary enucleation and four before intravitreous injection of melphalan in an eye treated for vitreous seeding. Evaluation of the aqueous humor showed tumor-derived, cell-free DNA and chromosomal copy number variations that represented tumor changes. Because tumor biopsy in retinoblastoma is contraindicated, it has not been possible to define the effects of secondary genetic changes on the course of retinoblastoma, the authors reported. The method they studied will allow for tumor-derived DNA analysis in retinoblastoma eyes having salvage therapy when the eyes have not been enucleated. The research is published in JAMA Ophthalmology.
PRODUCT NEWS
  • Bausch + Lomb (Bridgewater, New Jersey) has introduced the enVista MX60E with StableFlex IOL. This lens is considered the next generation of the company's hydrophobic acrylic lens, according to a company press release. The enVista MX60E will be commercially available in early 2018.
  • Topcon (Oakland, New Jersey) announced that its PASCAL Synthesis TwinStar laser has received FDA 510(k) clearance. The Synthesis further expands the PASCAL line of laser photocoagulators and has the ability to treat retinal disorders with a 577 nm yellow wavelength or a 638 nm red wavelength.

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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