EW Weekly, September 9, 2016

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September 9, 2016
Volume 21 , Number 32

Aerie files Rhopressa for U.S. approval

Aerie Pharmaceuticals (Irvine, California) has submitted a New Drug Application to the U.S. Food and Drug Administration for Rhopressa (netarsudil ophthalmic solution) 0.02% as a topical treatment to lower IOP in patients with glaucoma or ocular hypertension. The filing includes results from the first two Phase 3 registration trials of the compound. If approved, Rhopressa would be the only once-daily product to target both the trabecular meshwork and episcleral venous pressure. Company officials are expecting a standard, 12-month review process. In other news, Aerie stated its efficacy readout for Roclatan (netarsudil/
latanoprost ophthalmic solution) 0.02%/0.005% is expected this month.

Nidek's CEM-530 granted 510(k) approval

The U.S. Food and Drug Administration has issued 510(k) approval for the manual analysis function on the CEM-530 Specular Microscope, developer Nidek (Fremont, California) said in a press release. The company noted the new software upgrade function allows practitioners to analyze cells manually that were not identified by the auto-analysis function because of poor image quality.

RP candidate GS030 granted orphan drug designation in Europe

GS030, a gene therapy in development for the treatment of retinitis pigmentosa, has been granted orphan drug designation by the European Medicines Agency (EMA), developer GenSight (Paris) said in a press release. The EMA also granted an Advanced Therapy Medicinal Product designation to the therapy. GS030 is currently in preclinical development with a toxicity study in non-human primates expected to start this month, with a Phase 1/2 study in humans to begin in Q3 2017.

ASCRS Foundation's Operation Sight program looks to increase volunteer network

The ASCRS Foundation's U.S.-based charitable cataract surgery program, Operation Sight, is expanding its network of volunteer cataract surgeons in the U.S. in advance of its National Sight Week initiative, October 24-28. Operation Sight centralizes the patient vetting and eligibility process and provides financial support to help offset the cost of providing a charitable cataract surgery. Volunteer surgeons are matched with needy cataract patients in their own communities. The network includes established charitable organizations and ASCRS member volunteer surgeons. Whether treating many patients or just one, the members of the Operation Sight network have a direct, positive impact on the lives of those unable to afford cataract surgery. To become a member of the Operation Sight network or to learn more about the National Sight Week initiative, visit www.ascrsfoundation.org or contact Evelyn Morales at 703-591-2220.

RESEARCH BRIEFS

  • Younger donor age seems not to affect the clinical outcome of Descemet membrane endothelial keratoplasty (DMEK) surgery negatively within the first postoperative year, suggesting donor corneas with donor age down to 17 years as safe tissue for DMEK surgery, according to F. Schaub and colleagues. In their retrospective, comparative, interventional case series, records of 1,084 consecutive DMEKs were reviewed and matched with corresponding donor tissue data. Out of 529 included DMEKs, 94 (17.8%) were performed with young donor lamellae (mean donor age 49.316.35 years) and 435 (82.2%) with older donor tissue (mean age 70.687.77 years). Postoperative best corrected visual acuity, endothelial cell count, and central corneal thickness results were comparable in both groups at 6 and 12 months without statistically significant differences. Overall rebubbling rate in the younger donor group was 42.6% and in the older donors was 53.3% (P=.058). Complication rates also did not differ significantly. The study is published in the American Journal of Ophthalmology.
  • Long-term success of Ahmed glaucoma valve (AGV) implantation for the treatment of refractory glaucoma after vitreoretinal surgery with silicone oil insertion is better than that reported for trabeculectomy, although complication rates remain high, according to a new study. S. Gupta and colleagues prospectively evaluated 27 eyes (27 patients) that underwent AGV insertion for management of post-vitreoretinal surgery glaucoma, post-silicone oil removal. The mean age at AGV implantation was 28.315.2 years, and average follow-up after AGV implantation was 17.11 months. Kaplan-Meier survival analysis revealed a 62% success at 12 months and 37% at 5 years. A 48% rate of complications was noted, 22% of which were vision-threatening. The study is published in Graefe's Archives for Clinical and Experimental Ophthalmology.
  • The Lentis Mplus LS-312 MF30 IOL (Oculentis, Berlin) appeared to subjectively tolerate residual astigmatism well despite a statistically significant difference in uncorrected distance visual acuity (UDVA) with higher magnitudes of residual astigmatism, according to Richard McNeely and colleagues. At their setting in Belfast, U.K., this retrospective comparative case series evaluated 234 eyes of 117 patients undergoing refractive lens exchange with the Lentis IOL and categorized the eyes by magnitude of refractive astigmatism and corneal residual astigmatism. There was a significant difference in UDVA (P=.003), refractive sphere (P=.001), and defocus equivalent (P≤.001) between the residual refractive astigmatism groups; however, there was no difference in quality of vision (P=.28). The same was found for corneal astigmatism with UDVA (P≤.001) and quality of vision (P=.16). The angle of corneal astigmatism in relation to IOL placement did not statistically affect postoperative outcomes. The study is published in the Journal of Cataract & Refractive Surgery.

NEW PRODUCT BRIEFS

  • Rayner (East Sussex, U.K.) will launch the RayOne, a fully preloaded IOL injector, at the 2016 ESCRS Congress in Copenhagen. This flagship launch is the second in the pipeline of 11 new products that Rayner plans to launch over the next 3 years, the company said. The RayOne features Rayner's patented "Lock & Roll" technology, resulting in the "smallest fully preloaded injector nozzle available." The RayOne system is available in both spheric and aberration-neutral aspheric optics, from -10.0 to +34.0 D.
  • Heidelberg Engineering (Heidelberg, Germany) will launch the Cataract and Refractive Imaging Platform and the next generation Heyex for ophthalmic image management and device integration on the company's Spectralis system during the 2016 ESCRS Congress. Heidelberg will also debut the Flex Module and OCT2 module for retina applications, and the Glaucoma Module Premium Edition that will provide a comprehensive analysis of the optic nerve head, retinal nerve fiber layer, and ganglion cell layer. The company's Cataract and Refractive Imaging Platform uses high-resolution, swept-source OCT images to combine the most important examinations for anterior segment diagnostics in one modular, upgradeable system.

EYEWORLD WEEK Online is edited by Stacy Majewicz and Michelle Dalton.

EyeWorld Week Online (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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