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USA
CHINA INDIA ASIA PACIFIC KOREA RUSSIA
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October 31, 2014
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Volume 19, Number 37
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The ongoing pursuit of Allergan (Irvine, Calif.) by Laval, Canada-based Valeant continues, with Valeant now suggesting it may make an increased offer. News services have said the Canadian company may be willing to go more than $200/share for Allergan.
Allergan's board has, to date, firmly refused any offer Valeant has made, and the two companies are now mired in various litigation over the hostile takeover.
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Dropless cataract surgery shows promise |
A combination drug comprising triamcinolone acetonide and moxifloxacin hydrochloride (TriMoxi formulation) and a second variation that includes vancomycin (TriMoxiVanc formulation) have shown promise in early studies as single, injectable intraocular doses that eliminate the need for drops postoperatively, developer Imprimis Pharmaceuticals (San Diego) said.
In a paper titled "Transzonular Steroid/Antibiotic as Cataract Prophylaxis: Retrospective Analysis of 2300 Patients," presented at the 2014 American Academy of Ophthalmology meeting, all patients were seen postop on the same day (4-7 hours following surgery), at 3-4 weeks postop, and at 6 months postop. All surgeries took place between 2006 and 2013. No patients developed endophthalmitis, and 98% remained free from cystoid macular edema (CME) and inflammation. However, 19% of the patients also received supplement topical NSAIDs because of pre-existing diabetes, epiretinal membrane, or premium IOLs. |
Omidria granted pass-through reimbursement status from CMS
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Omeros Corporation (Seattle) announced that it has received transitional pass-through status for Omidria (phenylephrine and ketorolac injection) 1%/0.3% from the Center for Medicare & Medicaid Services (CMS), the federal agency that administers the Medicare program. Approved earlier this year by the FDA for use during cataract surgery or intraocular lens replacement (ILR), Omidria is the only FDA-approved product for intraocular administration that prevents intraoperative miosis (pupil constriction) and reduces postoperative pain. Transitional pass-through status will allow ambulatory surgery centers and other outpatient facilities to bill Medicare and other insurance providers for Omidria using a temporary Healthcare Common Procedure Coding System (HCPCS) code unique to Omidria. |
Luminate enters phase 2 study for DME |
Luminate, previously known as ALG-1001 (Allegro Ophthalmics, San Juan Capistrano, Calif.), has entered phase 2 studies for the treatment of diabetic macular edema (DME).
This phase 2 study is a randomized, controlled, double-masked, multicenter, dose-ranging trial to evaluate the safety and efficacy of intravitreal injections of Luminate compared to the current standard of care for patients with DME. Patients will be randomized to 1 of 5 treatment groups that include 3 Luminate groups (1.0 mg, 2.0 mg, or 3.0 mg), a bevacizumab (Genentech, South San Francisco) group, and a focal laser photocoagulation group. All study subjects will return for examinations every 4 weeks for 6 months. Total planned enrollment for the trial is 150 patients. |
Novel IOL system for dry AMD may be entering U.S. studies
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London Eye Hospital Pharma (U.K.) has "initiated U.S. discussions to gain clinical data" for its iolAMD lens system, a "novel intraocular lens system designed to restore lost vision and provide an independent lifestyle for patients with early, intermediate, and advanced dry AMD and other macular diseases including diabetic maculopathy," the company said in a press release.
The lens system is currently CE marked, and the procedure involves implanting 2 advanced hydrophobic acrylic IOLs that "work together to act like a Galilean telescope, gently magnifying the image entering the eye and diverting it to a healthier part of the retina," the company said.
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Nicox completes Aciex acquisition
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Nicox (Sophia Antipolis, France) has completed its acquisition of Aciex Therapeutics Inc., a private, U.S.-based, ophthalmic development pharmaceutical company. Terms of the deal were not disclosed. |
RESEARCH BRIEFS
- The centration of the treatment zone as measured by the Pentacam was better for patient-controlled fixation during small incision lenticule extraction (SMILE) than active eye tracker-assisted femtosecond laser-assisted LASIK (FS-LASIK), according to A. Lazaridis and colleagues. They compared 69 myopic eyes of 36 patients who underwent SMILE to 69 myopic eyes of 36 patients treated with FS-LASIK. All procedures were performed by a single surgeon using the VisuMax platform (Carl Zeiss Meditec, Jena, Germany). The Pentacam (Oculus, Wetzlar, Germany) was used for preoperative and postoperative topography and pachymetry. In SMILE cases, the mean decentration of the lenticule from the center of the entrance pupil was 0.326±0.196 mm (range: 0.014 to 1.062 mm), whereas the distribution of the lenticule centers demonstrated a nasalization pattern. In FS-LASIK cases, this value was 0.452±0.224 mm (range: 0.02 to 1.040 mm), whereas the ablation centers were distributed randomly. The decentration from the reference point of its technique (coaxial corneal light reflex in SMILE, the entrance pupil center in FS-LASIK) was significantly more extended in the FS-LASIK group (P<.001). The study is published in the Journal of Refractive Surgery.
- A loss to follow-up (LTF-referring to patients who discontinued visits for more than 2 years) was relatively common in hospital-based dry eye management in an Asian community, according to K.H. Poon and colleagues. Further, elderly patients have difficulty attending clinics due to nonmedical problems, which may require a more holistic approach. Of 505 patients, 240 (47.5%) were LTF between 2006 and 2010. Associated demographic factors for LTF were male sex, non-Chinese ethnicity, and age group <30 years old (all P<0.05). The reasons for LTF through the telephone survey (response rate 77.9%) were categorized into three broad groups: stabilized dry eye condition (47%), personal/social factors (25%), and perceived insufficiency of healthcare delivery (28%). Only two (1.1%) were considered as management failures. The younger patients (age <50 years) were more likely to become LTF (P<0.001) due to stabilized dry eye disease, compared to older patients who were more likely to be LTF due to personal/social reasons (P=0.02). The study is published in Patient Preferences and Adherence.
- Meibomian gland dysfunction (MGD) is widespread and has significant impact on patients' quality of life. Eyelid hygiene is the mainstay of treatment but is unstandardized and requires commitment from the patient and encouragement from the ophthalmologist, stated J.M. Benitez del Castillo and colleagues. Blephasteam (Spectrum Thea, Newcastle Under Lyme, U.K.) is an eyelid warming device designed to be an easy-to-use and standardized treatment for MGD. In the present study, 73 patients were treated for 21 days with twice daily Blephasteam sessions. The primary efficacy variable, a symptomatology visual analog scale score, declined from 63.07±21.23 (mean ± standard deviation) on day 0 to 41.90±25.49 on day 21. There were also improvements in a number of secondary efficacy variables including subjective ocular symptoms and clinical signs and symptoms of MGD and dry eye, though tear film breakup time and tear osmolarity were not improved. Global efficacy was assessed as satisfactory or very satisfactory in 83.8% of cases. Patient-reported subjective ocular symptoms declined during the study. Most patients found the device comfortable and were able to continue with normal activities (reading, watching TV, using a computer) during the Blephasteam session. No safety or tolerability issues were identified. The study is published in Clinical Ophthalmology.
NEW PRODUCT BRIEFS
- Johnson & Johnson Vision Care (Jacksonville, Fla.) announced the initial launch of 1-Day Acuvue Define contact lenses with Lacreon technology, a new category of "eye enhancement contact lenses that accentuate natural beauty while helping to support a healthy eye," the company said. The lens is already available in Asia, and widespread availability in the U.S. is expected in the first half of 2015.
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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: 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 Week 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 2014, EyeWorld News Service, a division of ASCRS Media. All rights reserved.
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