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USA
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January 09, 2015
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Volume 20, Number 02
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A combined dorzolamide hydrochloride and timolol maleate ophthalmic solution 2%/0.5% has been granted U.S. regulatory approval, developer Lannett Company (Philadelphia) said in a press release.
Lannett's drug is the generic equivalent to Cosopt (Akorn, Lake Forest, Ill.). |
Loteprednol NDA submitted
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An investigational new drug application (NDA) for a nano-suspension of loteprednol etabonate has been submitted to U.S. regulators to treat inflammation and pain after cataract surgery, developer Kala Pharmaceuticals (Waltham, Mass.) said in a press release.
A phase 3 clinical trial will be initiated to demonstrate equivalent anti-inflammatory efficacy of the mucus-penetrating particle with steroid-based treatments. The new platform "will permit less frequent dosing and offer similar safety to other loteprednol etabonate products," Kala said.
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EU approves Travatan for children
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Travatan eye drop solution (40 µg/mL travoprost, Alcon, Fort Worth, Texas) has been approved in Europe for pediatric patients with ocular hypertension or pediatric glaucoma. Travatan is now approved in the European Union for patients aged 2 months to <18 years, Alcon said in a news release.
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Macular edema associated with noninfectious uveitis p2 study underway
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Clearside Biomedical (Alpharetta, Ga.) has initiated a phase 2 randomized, controlled, masked, multicenter clinical trial of triamcinolone acetonide (CLS-TA) for the treatment of macular edema associated with noninfectious uveitis. Delivery will be via suprachoroidal injection, the company said in a press release.
Clearside plans to randomize 30 patients to receive either a single 4.0 mg dose or a 0.8 mg dose, with a primary endpoint of 2 months post-treatment. Secondary efficacy endpoint includes improvements in visual acuity (mean change from baseline).
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Consumer-directed digital reporting on eye health
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Optical Express (Edinburgh, Scotland) is offering a web-based service allowing consumers to report digitally on eye health via a new platform called iScan. The company noted that telemedicine can help manage increasing public sector healthcare costs associated with the aging population by diagnosing medical conditions in the early stages.
The iScan platform will be hosted on the cloud, allowing increased access to medical data by opticians and clinicians, including a 3D map of the eye.
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CZM inks 2-year deal with Oraya
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Carl Zeiss Meditec (CZM, Jena, Germany) will collaborate with Oraya Therapeutics (Newark, Calif.) for up to 2 years, the companies announced. According to terms of the deal, CZM's financing will support expansion of Oraya's low energy X-ray radiation therapy for the treatment of wet age-related macular degeneration. Oraya's therapy is currently commercially available in Germany, the U.K., and Switzerland.
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Private partnership funds RP project
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A group of European companies will put up 18.5 million euros over the course of 5 years to fund SIGHT AGAIN, a project that aims "to restore vision to legally blind patients with retinitis pigmentosa at different stages," according to a press release.
Coordinated by Paris-based GenSight Biologics, SIGHT AGAIN will develop an optogenetic gene therapy product and a vision restoration system with a retinal implant (dubbed PRIMA). The simulation device comes in the form of goggles, enabling image capture, processing, and projection onto the retina. The goal is to restore visual function in the retina and to transmit visual information to the brain. The rehabilitation protocol will include teaching patients how to use and interpret the new form of vision, according to the release.
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Minimizing the risk of TED in patients with Graves disease
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Surgical thyroidectomy alone or combined with medical therapy can decrease the risk of thyroid eye disease (TED) by up to 74%, according to researchers at the University of Michigan Kellogg Eye Center, Ann Arbor.
Findings were based on an analysis of healthcare claims data (including diagnoses, tests ordered, medications prescribed, and surgeries performed) for 8,404 individuals with newly diagnosed Graves disease. Approximately 8.8% of these patients eventually developed TED. Surgical thyroidectomy, either alone or with radioactive iodine therapy, decreased the risk of TED by 74%, the university said. The use of statins was associated with a 40% decreased risk for TED compared with less or no use of statins.
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RESEARCH BRIEFS
- Early consideration of lamellar keratoplasty in patients with ocular comorbidities is warranted, according to R.H. Epstein and colleagues. They described the case of a 68-year-old female patient with bilateral keratoconus who experienced persistent visual acuity deficits after cataract extraction with a Nd:YAG capsulotomy in her right eye. Penetrating keratoplasty (PKP) in the patient's right eye was successful until steroid drops were discontinued 10 years later owing to persistent intraocular pressure. Before the patient died at the age of 95, she underwent 3 PKPs, 1 Descemet's stripping endothelial keratoplasty (DSEK), and a trabeculectomy with an anatomically successful DSEK in her right eye. A single PKP proved successful in the patient's left eye. This case study is published in the Journal of Cataract & Refractive Surgery.
- Switching patients with neovascular age-related macular degeneration (AMD) to Eylea (aflibercept, Regeneron, Tarrytown, N.Y.) treatment from Avastin (bevacizumab, Genentech, South San Francisco) or Lucentis (ranibizumab, Genentech) resulted in a significant decrease in the number of injections, central retinal thickness, and retinal pigment epithelial detachment volume; however, visual acuity remained unchanged. Mariana R. Thorell, MD, and colleagues conducted a retrospective study of 65 patients (73 eyes) with neovascular AMD, who were switched to aflibercept because of persistent macular fluid after treatment with intravitreal bevacizumab or ranibizumab. Treatment with bevacizumab or ranibizumab was provided for at least 1 year. Patients were re-treated at least every 6 weeks, before switching, and followed up at 6 months. The switch to aflibercept occurred on or around 45 months, with a mean number of bevacizumab or ranibizumab injections of 31. Six months after the switch, the mean number of injections decreased by 0.6 compared with the 6 months before the switch (P<.001), central retinal thickness decreased by 19 µm (P<.001), and retinal pigment epithelial detachment cube-root volume decreased by 0.07 mm (P=.007). However, the change in visual acuity was not statistically significant 6 months after the treatment switch. This study is published in Ophthalmic Surgery, Lasers and Imaging Retina.
- Following successful trabeculectomy, end-diastolic velocities of the central retinal artery and of the temporal posterior ciliary arteries increased and remained stable, even when patients' intraocular pressure (IOP) rose significantly at follow-up. David Kuerten, MD, and colleagues performed color Doppler imaging to investigate the long-term effects of trabeculectomy on retrobulbar hemodynamics in patients with primary open-angle glaucoma (POAG). This prospective study included 30 patients (mean age 63.2±15.4 years) with POAG. Imaging was performed 1 to 2 weeks before, 2 months after, 4 to 6 months after, and up to 3 years after trabeculectomy to establish patients' peak systolic and end-diastolic velocities in the ophthalmic artery, central retinal artery, and short nasal and temporal posterior ciliary arteries. Compared with pre-surgical velocities, end-diastolic velocities of the central retinal artery and of the temporal posterior ciliary arteries were increased at all postoperative visits (P<0.003). This study was published in Ophthalmic & Physiological Optics.
NEW PRODUCT BRIEFS
- CooperVision (Pleasanton, Calif.) introduced MyDay lenses in Hong Kong. Heralded as the next generation of silicone hydrogel lenses, the lenses protect users' eyes from 85% of UVA and 96% of UVB rays, the company said.
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EyeWorld Weekly Update is edited by Stacy Majewicz and Michelle Dalton.
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: David F. Chang, MD, chief medical editor; Bonnie An Henderson, MD, cataract editor; Clara C. Chan, MD, cornea editor; Reay H. Brown, MD, glaucoma editor; Eric D. Donnenfeld, MD, refractive editor; and John A. Vukich, MD, international editor For sponsorship opportunities or membership information, contact: ASCRS *ASOA * 4000 Legato Rd. * Suite 700 * Fairfax, VA 22033 * Phone: 703-591-2220 * Fax: 703-591-0614 * Email: ASCRS Opinions expressed in EyeWorld Weekly Update do not necessarily reflect those of ASCRS*ASOA. Mention of products or services does not constitute an endorsement by ASCRS*ASOA.
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Copyright 2015, EyeWorld News Service, a division of ASCRS Media. All rights reserved.
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