EyeWorld Weekly Update, February 16, 2018

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February 16, 2018
Volume 24 , Number 5

FDA approves drug to treat post-cataract surgery inflammation

The U.S. Food and Drug Administration (FDA) has approved dexamethasone intraocular suspension (Dexycu, Icon Bioscience, Newark, California), used to treat inflammation associated with cataract surgery. The agent is a dropless, long-acting therapeutic that uses a Verisome drug-delivery platform. It is applied as a single intraocular administration when surgery ends, according to a company press release. The Verisome platform dispenses a biodegradable extended-release formulation of dexamethasone into the eye's posterior chamber.

I-MED Pharma wins Canadian patent case

I-MED Pharma (Montreal, Quebec) has won a patent case against TearLab (San Diego) relating to I-MED's I-PEN Osmolarity System. According to an I-MED press release, TearLab brought a federal suit in Canada in February 2016, alleging that the I-PEN, sold in Canada, infringed a Canadian patent. TearLab, which sells its TearLab Osmolarity System in Canada, sought a permanent injunction to keep I-PEN off the market. This week, the court ruled in I-MED Pharma's favor and awarded costs.

Phase 1/2 data on carotuximab for wet AMD announced

Bioactivity occurred in a Phase 1/2 study of carotuximab (DE-122, Santen, Emeryville, California), according to top-line results. Carotuximab was developed to treat refractory wet age-related macular degeneration (AMD). The open-label, dose-escalation, sequential-cohort study assessed safety, tolerability, and bioactivity of a single intravitreal injection of DE-122 given at four dose levels in 12 subjects. All subjects had wet AMD refractory to vascular endothelial growth factor (VEGF) inhibitors, and all were followed up to 90 days. Study results suggested bioactivity as measured by mean change in central retinal subfield thickness based on spectral domain OCT; no serious adverse events were reported. DE-122 is now under analysis in a Phase 2a randomized controlled trial that assesses the efficacy and safety of intravitreal injections combined with ranibizumab (Lucentis, Genentech, South San Francisco) compared with ranibizumab monotherapy in wet AMD patients, according to a Santen press release.

Second Phase 3 trial data for Durasert for posterior segment uveitis released

Results from a second Phase 3 trial for Durasert (pSivida, Watertown, Massachusetts) for posterior segment uveitis showed a significant decrease in uveitis recurrence rate at 12 months, based on 3-year treatment. The company's study included 153 patients with posterior segment uveitis. The primary endpoint was prevention of posterior uveitis recurrence at 6 months; patients continued to be followed for 36 months. Among the Durasert-treated patients, 36.6% had a recurrence compared with 71.2% of patients in the sham group (P<0.001). There was a mean IOP increase of 2.0 and 0.0 mm Hg at 12 months over a baseline IOP of 13.3 and 13.1 mm Hg for Durasert and sham, respectively. Among patients with a phakic lens at baseline, 18% required cataract surgery through 12 months in the Durasert group compared with 8.6% in the sham group. The company is awaiting the FDA's decision on acceptance of its New Drug Application submitted in January, according to a company press release.

RESEARCH BRIEFS

  • Sequential surgery may be preferred over combined surgery in patients requiring Descemet's membrane endothelial keratoplasty (DMEK), according to Pia Leon, and co-researchers in a case control study that evaluated the risk factors for early graft detachment in DMEK. There were 173 donor corneas and 173 eyes included from patients following DMEK or DMEK combined with phacoemulsification and IOL implantation. The pull-through technique was used to transplant the pre-stripped DMEK grafts. Rebubbling was performed in any case of graft detachment. Researchers analyzed donor and recipient characteristics affecting graft detachment. Independent risk factors for postop graft detachment were the combination of DMEK with cataract removal and IOL implantation and air fill of 75% of anterior chamber height at 2-3 hours postop. In the early hours after surgery, the air level in the anterior chamber should be monitored and maintained above 75%, the researchers concluded. The study is published in the American Journal of Ophthalmology.
  • Intravitreous injections of VEGF inhibitors are associated with a small but statistically significant decrease in IOP over time, according to Elizabeth Atchison, and co-researchers, who analyzed data from the American Academy of Ophthalmology's IRIS Registry. The study included 23,776 patients who received just one type of anti-VEGF medication by injection in the right eye. Researchers included patients with at least 12, 18, and 25 injections of bevacizumab (Avastin, Genentech), aflibercept (Eylea, Regeneron Pharmaceuticals, Tarrytown, New York), or ranibizumab (Lucentis); the fellow untreated eyes were used for comparison. "All patients in all groups receiving all drugs showed a decrease in IOP from baseline," the researchers wrote. There was a mean 0.9 mm Hg decrease in treated eyes compared with a mean decrease of 0.2 mm Hg in fellow untreated eyes. Bevacizumab was associated with slightly less lowering of IOP in most subgroups. In 2.6% of eyes, a clinically significant IOP increase was seen in eyes that received injections compared with 1.5% in the associated untreated fellow eyes. The research is published in Ophthalmology.
  • Clinically significant LASIK flap striae occurred in 0.79% of eyes in a multi-surgeon, multicenter retrospective case control series with 109,403 eyes that had LASIK, according to Avi Wallerstein, MD, and co-researchers. In 8.7% of patients, the flap striae were irrigated the first hour after surgery. Preop spherical equivalent and ablation depth significantly increased the striae risk. A small hyperopic shift was induced by striae, which reversed after the relift. After relifting, 68%, 87%, and 96% of eyes had an uncorrected distance visual acuity (UDVA) of 20/20, 20/25, and 20/40 or better compared with 25%, 55%, and 84%, respectively, before the relift. In eyes with treated striae, 13% fewer achieved a UDVA of 20/20. Lifting and irrigation treatment improved the accuracy, efficacy, and safety to a level comparable to contralateral control eyes, but striae-treated eyes were more likely to need excimer laser treatment, the researchers concluded. The research appears in the Journal of Cataract & Refractive Surgery.
  • A higher dietary consumption of omega-3 fatty acids was associated with a lower likelihood of glaucomatous optic neuropathy, according to Ye Elaine Wang, MD, and co-researchers. However, in the higher quartiles of omega-3 consumption, there was a higher risk of glaucoma. Their cross-sectional population study included participants from the National Health and Nutrition Examination Survey 2005 to 2008 database. Among the survey participants, 3.7% met the study's criteria for having glaucoma. Although increased levels of eicosapentaenoic acid and docosahexaenoic acid were associated with significantly lower odds of glaucoma, participants with daily total dietary polyunsaturated fatty acid in the second and third quartiles had significantly increased odds of a glaucoma diagnosis. This may have resulted from relative intakes of omega-6 and omega-3 fatty acids and other confounding morbidities, the researchers reported. Increasing the proportion of dietary omega-3 consumption levels while controlling overall daily polyunsaturated fatty acid intake may be protective against glaucoma, the researchers concluded. More longitudinal studies or randomized clinical trials are needed, they wrote. The study appears in JAMA Ophthalmology.

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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