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USA
CHINA INDIA ASIA PACIFIC KOREA RUSSIA
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December 5, 2014
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Volume 19, Number 42
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Priority review granted for DR drug
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The Food and Drug Administration has accepted for priority review the supplemental biologics license application for Eylea (aflibercept) for the treatment of diabetic retinopathy (DR) in patients with diabetic macular edema (DME), developer Regeneron (Tarrytown, N.Y.) said in a news release. A target action date by the FDA is March 30, 2015, Regeneron added.
Eylea was previously granted breakthrough therapy designation for the treatment of DR in patients with DME.
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Apotex granted ANDA for bimatoprost
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The Food and Drug Administration has granted regulatory approval to an Abbreviated New Drug Application (ANDA) from Apotex (Toronto) for bimatoprost 0.03%. Apotex's version is the generic equivalent to Lumigan, Allergan's topical drug for the treatment of glaucoma.
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HIV/AIDS drugs could be repurposed for AMD |
Researchers at the University of Kentucky suggest that HIV/AIDS drugs that have been used for the last 30 years could be repurposed to treat age-related macular degeneration (AMD), as well as other inflammatory disorders, because of a previously undiscovered intrinsic and inflammatory activity those drugs possess, according to a university news release. Nucleoside reverse transcriptase inhibitors (NRTIs) are the most widely used class of anti-HIV drugs, and researchers found that a type of toxic molecule called Alu RNA accumulate in the retina to cause dry AMD; interestingly, Alu RNA and HIV are similar in that they both require reverse transcriptase to fulfill their life cycle. Further, several approved NRTIs prevented retinal degeneration in a mouse model of dry AMD by blocking an innate immune pathway (inflammasome), and these NRTIs were equally effective in neovascular AMD as well as graft-versus-host disease. |
Diagnostics/devices market to reach $40 billion |
According to new market research, the global ophthalmology diagnostics and surgical devices market will increase from $26 billion in 2012 to $40 billion by 2019. In its report, Transparency Market Research (Albany, N.Y.) said the three main categories are diagnostic devices (fluorescein angiography, slit lamps, fundus cameras, pachymeters, gonioscopes, ophthalmic echography, specular microscopes, corneal topographers, ophthalmoscopes, autorefractometers, keratometers, tonometers, optical coherence tomography systems, and perimeters), ophthalmology surgery devices (glaucoma surgery devices, cataract surgery devices, refractive surgery devices, and vitreoretinal surgery devices), and vision care (spectacle lenses and contact lenses).
Further, the diagnostics and surgical devices market is fueled by the growing incidence of ocular disorders, a rise in the geriatric population, technological advancements, and growth in emerging economies. In contrast, the high cost of high-tech devices is expected to restrain the ophthalmology diagnostics and surgical devices industry. |
Ocular drug delivery systems report released |
Given the intricacy of the anatomy and physiology of the eye, it is "quite challenging to deliver an ophthalmic drug effectively to a specific ocular site. Several barriers have to be overcome for successful ocular drug delivery," according to ReportBuyer (London). The market research firm noted industry and academia are working on novel implants, including drug-eluting contact lenses and punctal plugs, for treatment of anterior segment diseases such as glaucoma and conjunctivitis, all of which are highlighted in the "Sustained Release Ocular Drug Delivery Systems, 2014-2024" report, according to a press release.
The report covers various aspects such as technological progress, product pipeline, industry and academic research programs to assess new evolving opportunities.
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'Soprano' opens in Singapore
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The Singapore Ophthalmology Research Collaborative Network (Soprano), which brings together ophthalmologists from institutions such as the Singapore Eye Research Institute (SERI), the Singapore National Eye Centre (SNEC), and all major public hospitals with an eye department, has launched, according to local reports.
While SERI is already involved in researching numerous ophthalmic diseases, the collaboration will expand those research efforts, SERI said in a news release.
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Imprimis buys compounding pharmacy |
Imprimis Pharmaceuticals (San Diego) will buy South Coast Specialty Compounding, DBA Park Compounding (Park), according to a press release. As part of the transaction, Imprimis also entered into a non-exclusive license agreement with Park, allowing Park to immediately begin making and dispensing Imprimis' proprietary ophthalmology and urology formulations, among them its patent-pending "go dropless" ophthalmic formulation. |
- Ophthalmic Women Leaders (OWL) has named Angela Bedell its new executive director.
- ONL Therapeutics has appointed David Kleinman, MD, as chief medical officer. Co-founder David Zacks, MD, will transition from president and chief medical officer to chief science officer. The company is developing ONL101, a "first-in-class therapeutic that works by protecting photoreceptors against the apoptosis that occurs during the course of a broad range of retinal diseases and conditions," ONL said.
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RESEARCH BRIEFS
- Fifty percent autologous serum (AS) eye drops seem to be a safe and effective long-term treatment for dry eye disease, especially in patients with severe disease who have exhausted all other conventional forms of treatment, according to M. Hussain and colleagues. They retrospectively evaluated 123 eyes of 63 patients treated with 50% AS eye drops between June 2008 and January 2013 at their institution. Corneal fluorescein staining (mean baseline, 1.77±1.1) improved at all time points, with a final score of 1.1±1.1 (P=0.0003). Schirmer scores (mean baseline, 6.6±6.5 mm) improved at the 12- to 24-month follow-up (mean=10.7±11.4, P=0.03), whereas ocular surface disease index scores (mean baseline, 54.1±22.3) improved at the 3- to 6- and 6- to 12-month follow-up (mean: 49.5±8.2 and 39.3±21.4, P=0.029 and 0.003, respectively). No complications were noted. The study is published in Cornea.
- Femtosecond laser capsulotomies showed better circularity with more predictable size than manual continuous curvilinear capsulorhexis (CCC), according to Leonardo Mastropasqua, MD, and colleagues in the Journal of Cataract & Refractive Surgery. In their prospective, randomized clinical study, the group divided 1 eye of patients into 1 of 3 groups: LenSx (Alcon, Fort Worth, Texas) femtosecond laser-assisted cataract surgery capsulotomy (laser group 1; n=30), LENSAR (Orlando, Fla.) femtosecond laser-assisted cataract surgery capsulotomy (laser group 2; n=30), and manual CCC (manual group; n=30). The capsulotomies in laser group 1 and laser group 2 showed significantly better circularity than the manual CCCs at 7 days (P<.001). There was a significant correlation between the intended versus achieved capsulotomy size in the 2 laser groups. Both laser groups had better IOL centration than the manual group at all time points (P<.001). Between-group differences in uncorrected and corrected distance visual acuities were not statistically significant. The residual spherical equivalent and mean absolute error were statistically significantly smaller in the 2 laser groups than in the manual group (P=.038) and increased significantly over time in all the groups (P<.001).
- Early one-step transepithelial photorefractive keratectomy (PRK) with mitomycin-C seems to be a safe and effective treatment for LASIK buttonhole complication, according to M.R. Abdulaal and colleagues. They evaluated 8 patients who developed a buttonhole during LASIK with mechanical or femtosecond flap creation and who underwent 1-step transepithelial PRK a few days after the formation of the buttonhole. The retreatment procedure was performed after complete epithelial healing and smooth epithelial fluorescein profile were ensured. Mean duration of the retreatment procedure after buttonhole formation was 5 days (range: 4 to 7 days). Mean manifest refractive spherical equivalent and cylinder refraction were -0.05±0.18 and -0.18±0.22 D, respectively, at 6 months postoperatively. Uncorrected distance visual acuity was 20/20 in all patients after 3 months of follow-up. No haze formation was detected. The study is published in the Journal of Refractive Surgery.
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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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