Absorbable, non-absorbable sutures receive U.S. nod
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U.S. regulators have granted approval to U.S. IOL (Lexington, Ky.) for its line of absorbable and non-absorbable sutures. The company said its high strength, burr-free, stainless steel needles provide "maximum form stability," and its suture threads are specially coated for a smooth, drag-free passage through tissue.
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Generic Lumigan granted U.S. approval
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U.S. regulators have granted approval to Lupin Pharmaceuticals (Baltimore) for its bimatoprost ophthalmic solution 0.03%, the company said. Lupin's product is the generic equivalent of Lumigan (bimatoprost ophthalmic solution 0.03%, Allergan, Irvine, Calif.) and is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.
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Top-line phase 3 study results on OTX-DP look promising
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Positive topline data from the first of two phase 3 clinical trials evaluating the safety and efficacy of OTX-DP (sustained release dexamethasone), for the treatment of ocular inflammation and pain following cataract surgery, have been released, developer Ocular Therapeutix (Bedford, Mass.) said in a press release.
The phase 3a study, which enrolled 247 patients, met both primary efficacy measures, achieving a statistically significant improvement in the reduction of inflammatory cells and pain: 33.7% of OTX-DP treated patients showed an absence of inflammatory cells in the anterior chamber of the study eye on day 14 following drug product insertion, compared to 14.6% of those receiving placebo vehicle control punctal plug (P=0.0015). In addition, 76.1% of patients receiving OTX-DP reported absence of pain in the study eye on day 8 following insertion of the drug product, compared to 36.1% of those receiving placebo vehicle control punctal plug (P<0.0001). Safety findings are still being analyzed.
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IND for X-linked retinoschisis gene therapy filed
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Applied Genetic Technologies (Gainesville, Fla.) has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration to conduct a phase 1 and 2 clinical trial of the company's gene therapy product candidate for the treatment of X-linked retinoschisis (XLRS). Utilizing technology licensed from the University of Florida, the company's XLRS product candidate uses "an AAV capsid with surface residues that have been specifically engineered for better penetration to the back of the eye," according to a press release.
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Vision For Mars Challenge winners announced
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The National Space Biomedical Research Institute (NSBRI, Houston) Industry Forum has selected and funded 3 companies to further develop unique technologies that address visual problems in space as well as on Earth. These companies are Annidis (Grandville, Mich.), which has developed the Annidis RHA ophthalmoscope; Equinox (Sioux Falls, S.D.), founded by John Berdahl, MD, who is developing the Balance Goggles; and Web Vision Centers Group (South Jordan, Utah), which will work with several vision lens companies to customize adjustable prescription glasses for spaceflight.
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Patented amblyopia treatment turned into video game
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Two Atlanta-based companies have collaborated to develop a video game "based on a patented method exclusively used for the treatment of amblyopia," Ubisoft and Amblyotech said in a joint news release. "Dig Rush" features patented electronic therapy that has been tested to "significantly increase the visual acuity of both children and adults who suffer from this condition without the use of an eye patch."
Instead of training just the weak eye, the new game uses both eyes to train the brain in order to improve visual acuity of the patient by using different contrast levels of red and blue that can be seen through stereoscopic glasses. Using this method, the physician can adjust the game's settings in accordance with the specific patient's weak eye's condition, allowing both eyes to see the gameplay unfolding, the companies said.
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RESEARCH BRIEFS
- Retaine ophthalmic emulsion (carboxymethylcellulose sodium 0.5%, OCuSOFT, Rosenberg, Texas) provides enhanced comfort and improves the quality of life of dry eye subjects while reducing the ocular signs of dry eye, according to a new study. George Ousler III and colleagues enrolled 42 patients and instructed them to instill 1-2 drops twice daily beginning at the first visit (day 1) and ending at the second visit (around 2 weeks). Subjects were instructed to complete a symptomatology diary twice daily prior to drop instillation through the morning of the second visit. Ocular sign and symptom assessments, visual acuity procedures, and comfort assessments were conducted during both visits. A statistically significant reduction was observed in mean breakup area on the second visit between the pre-dose time and the post-dose time (P=0.026). On the second visit, subjects had significantly less corneal fluorescein staining in the superior (P=0.002), central (P=0.017), corneal sum (P=0.011), and all ocular regions combined (P=0.038) than on the first visit. On the second visit, statistically significant reductions in dryness (P<0.001), grittiness (P=0.0217), ocular discomfort (P=0.0017), and all symptoms (P<0.001) were also seen. The study is published in Clinical Ophthalmology.
- Trabeculectomy is cost effective at a substantially lower cost per quality-adjusted life years (QALYs) compared with tube insertion, according to Richard I. Kaplan, MD, and colleagues. They used a Markov cohort model with a 5-year time horizon to study a hypothetical cohort of 100,000 patients who required glaucoma surgery to determine QALY gained, costs from a societal perspective, and incremental cost-effectiveness ratio of medical treatment, trabeculectomy, and tube insertion. The mean costs for medical treatment, trabeculectomy, and tube insertion were $6,172, $7,872 and $10,075, respectively; these amounts resulted in a cost difference of $1,700 for medical treatment vs. trabeculectomy, $3,904 for medical treatment vs. tube insertion, and $2,203 for trabeculectomy vs. tube insertion. The mean 5-year probability of blindness was 4% for both surgical procedures and 15% for medical treatment. The utility gained after medical treatment, trabeculectomy, and tube insertion was 3.10, 3.30, and 3.38 QALYs, respectively. The incremental cost-effectiveness ratio was $8,289 per QALY for trabeculectomy vs. medical treatment, $13,896 per QALY for tube insertion vs. medical treatment, and $29,055 per QALY for tube insertion vs. trabeculectomy. The study is published in JAMA Ophthalmology.
- Chronic obstructive pulmonary disease reduced endothelial functional reserve and increased corneal endothelial vulnerability to intraocular surgical stress, according to Núria Soler, MD, and colleagues. They prospectively enrolled 165 eyes and assigned patients to 1 of 3 groups: mild to moderate chronic obstructive pulmonary disease (COPD; n=67 eyes), severe to very severe COPD (n=40 eyes), and without COPD (control; n=58 eyes). Significant differences in nearly all preoperative and 3-month postoperative corneal endothelial parameters were observed between the COPD groups and the control group, the former having a lower cell density and percentage of hexagonal cells and a higher coefficient of variance of the mean cell area. The control group reported no corneal edema, while rates in the COPD groups were more than 30%. There was no significant difference in the preoperative or 3-month postoperative mean central corneal thickness between the groups. The study is published in the Journal of Cataract & Refractive Surgery.
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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: ASCRSOpinions 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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