Clinical trial of stem cell-based retinitis pigmentosa treatment begins
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A team from University of California, Irvine (UCI) is currently seeking participants to be enrolled in the first clinical trial to test the use of retinal progenitor cells to treat retinitis pigmentosa, according to a press release from UCI. These cells are similar to stems cells but specific to the retina. At this point, 4 people with retinitis pigmentosa have received cell injections. The trial is an open-label phase 1/2a trial that is designed to evaluate the safety of the retinal progenitor cells injected into the vitreous cavity at 2 different dosage levels in patients with late-stage RP. Total enrollment will be 16 patients, and participants will be followed for 12 months. Safety and efficacy parameters will be monitored.
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Alimera Sciences Limited to be exclusive distributor of ILUVIEN in certain areas
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Alimera Sciences Limited (London) will be the exclusive distributor of ILUVIEN (fluocinolone acetonide intravitreal implant) for Italy, San Marino, and Vatican City, according to a press release from the company. This 5-year agreement was reached with Societa Industria Farmaceutica Italiana S.p.A. (SIFI, Catania, Italy), which will handle all promotion, marketing, and commercial activities in those locations for ILUVIEN, Alimera's sustained release intravitreal injection for the treatment of diabetic macular edema.
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Pathway discovered leading to blindness from age-related macular degeneration
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Researchers have indicated that there is a pathway leading to the formation of atypical blood vessels that can cause blindness in people with age-related macular degeneration, according to an article from the newsroom of Washington University in St. Louis. The data shows a better understanding of how immune cells factor into macular degeneration. Inhibiting the specific molecular pathways could help halt the progression and possibly restore sight for people with this problem.Research indicates that a "a cell-signaling molecule, called interleukin-10 (IL10), plays a role in the formation of blood vessels involved in the 'wet' form of macular degeneration, which is more frequently linked to blindness than the 'dry' form of the disease," according to the university. IL10 levels will increase in the eye before vision loss and so will the number of specific immune cells. Until this research, how IL10 actually contributed to the proliferation of macrophages and damaging blood vessels wasn't well understood.
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AGTC announces collaboration with Biogen on gene-based therapies
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AGTC (Alachua, Fla.) and Biogen (Cambridge, Mass.) have announced a broad collaboration and license agreement between the 2 companies to develop gene-based therapies for several ophthalmic diseases. The companies reported via press release that they want to develop a portfolio of AGTC's therapeutic programs. Within their collaboration and agreement, there is also the option for early stage discovery programs. "We expect this collaboration will further validate our novel adeno-associated virus (AAV) gene therapy platform and support the development of new therapies that may allow for transformative treatments for these rare inherited eye diseases and other clinical indications," said Sue Washer, president and CEO of AGTC, in the press release.
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Clarity Medical Systems hires executives specifically for HOLOS IntraOP product
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Clarity Medical Systems (Pleasanton, Calif.) has announced additions to its executive team. These new hires are meant to focus specifically on the commercial introduction of the HOLOS IntraOP product, which is a "continuous real-time intraoperative aberrometer for refractive cataract surgery," according to the company.
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Research Briefs
- Bevacizumab as currently used across the U.S. does not increase the risk for endophthalmitis, according to a recent study. Conclusions suggest that additional regulations on the use of repackaged bevacizumab may be unnecessary. The purpose of this retrospective cohort study was to determine whether the distribution of bevacizumab through compounding pharmacies would increase risk of endophthalmitis when compared with the use of single-use vials of ranibizumab from the manufacturer. The study used medical claims data from across the U.S. Brian L. VanderBeek, MD, and colleagues looked at injections between 2005 and 2012 and ultimately examined 383,810 intravitreal injections for 58,612 patients for analysis in the study. In the results, 296,565 injections of bevacizumab were given to 51,116 patients and 87,245 injections of ranibizumab were given to 7,496 patients. There were 71 cases of endophthalmitis (49 of the bevacizumab group and 22 of the ranibizumab group). When factoring in age, race, and other significant factors, it was determined that there was no significant association with development of endophthalmitis after bevacizumab injection compared with ranibizumab. The study was published online first in JAMA Ophthalmology.
- Trabeculectomy can be done under augmented topical anesthesia, according to a study on pain evaluation and surgical feasibility. The tertiary care center-based interventional case series examined by S.K. Gupta and colleagues found that this method provided adequate analgesia for acceptable patient and surgeon comfort, as well as favorable outcomes. Topical anesthesia was evaluated using 2% lignocaine jelly with intracameral 1.0% lignocaine for trabeculectomy. This study looked at 15 eyes of 14 patients; patients underwent a standard ab externo trabeculectomy under topical anesthesia. The pain evaluation was done within 1 hour of surgery using a visual analog scale with the modified Wong-Baker FACES Pain Rating Scale. The mean (SD, range) age of patients was 61.3 (17.54, 40-90, distributed normally) years. The pain score analysis showed a mean (SD, range) visual analog scale score of 0.73 (0.59, 0-2) on a scale of 0 to 10. The mean (SD, range) surgeon's satisfaction score was 3.2 (0.4, 3-4) on a scale of 3 to 9. The intraocular pressure of all patients was well controlled at 2 weeks (mean [SD, range], 9.2 [2.9, 4-16]) and at 4 weeks (mean [SD, range], 13.2 [1.2, 11-15]) postoperatively without any topical or systemic anti-glaucoma medications. The study concluded that this anesthesia method provides a safe trabeculectomy surgery with an acceptable amount of discomfort for the patient. The study is published online ahead of print in the Asia-Pacific Journal of Ophthalmology.
- The presence of a contact lens after Boston keratoprosthesis implantation decreases the risk of postoperative complications, and the benefit of this has been statistically documented in a review aimed at evaluating associations between preoperative diagnosis, soft contact lens retention, and complications. The retrospective chart reviews conducted by Leah Kammerdiener, MD, and others, examined 103 eyes of 92 adult patients. All patients received a Boston keratoprosthesis type I at either the Massachusetts Eye and Ear Infirmary or the Flaum Eye Institute. In this review, 50% of the lenses had been lost after about a year period, with 17 patients experiencing more than 2 soft contact lens losses per year. Furthermore, the review indicated that the preoperative diagnosis was not predictive of contact lens retention. However, the absence of a contact lens was itself an independent risk factor for postoperative complications. The review was published online in the British Journal of Ophthalmology.
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EyeWorld Weekly Update is edited by Stacy Jablonski 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: Eric D. Donnenfeld, MD, chief medical editor; Rosa Braga-Mele, MD, cataract editor; Clara C. Chan, MD, cornea editor; Reay H. Brown, MD, glaucoma editor; Steven C. Schallhorn, MD, refractive editor; and John A. Vukich, MD, international editor
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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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