EW Weekly, March 24, 2017

March 24, 2017
Volume 22 , Number 12

Three patients blindedfrom stem cell treatment

Three patients went blind after they received eye injections of stem cells, The New England Journal of Medicine reported. The patients were seen by some of the report's co-investigators, led by Ajay E Kuriyan, MD. The experimental treatments were performed at a stem-cell clinic and involved stem cells derived from the patients' own abdominal fat. Patients who received the treatments were in the early stages of age-related macular degeneration. "The patients' severe visual loss after the injection was associated with ocular hypertension, hemorrhagic retinopathy, vitreous hemorrhage, combined traction, and rhegmatogenous retinal detachment, or lens dislocation," the investigators wrote. "After 1 year, the patients' visual acuity ranged from 20/200 to no light perception." The company sponsoring the treatments was U.S. Stem Cell, Inc. Authors said the cases demonstrate the need for greater public protection against stem cell treatments. The three patients were from Florida. The American Academy of Ophthalmology issued a statement early this week to say that that it released clinical guidance last year regarding the appropriate use of stem cell treatment in eye care. A previous article in Ophthalmology addressed the need for stem cell treatment oversight, according to the statement. "The Academy has called on both the National Institutes of Health and the U.S. Food and Drug Administration [FDA] to take steps to better ensure public safety associated with treatment outside of FDA-approved clinical trials," the AAO stated.

New inexpensive retina camera eliminates need for dilation

A pocket-sized retina camera developed by researchers at the University of Illinois College of Medicine, Chicago, and Massachusetts Eye and Ear/Harvard Medical School, Boston, would enable photographs of the eye without the need for dilating drops. The camera, which costs $185 to make, is based on a low-cost, single-board computer called a Raspberry Pi 2. "The board hooks up to a small, cheap, infrared camera and a dual infrared- and white-light emitting diode," according to the press release. The camera first emits infrared light that the iris does not react to. The infrared light is used to focus the camera on the retina, and a quick flash of light is delivered to take a picture. "This is an open-source device that is cheap and easy to build," said Shizuo Mukai, MD, one of the camera's developers. "We expect that others who build our camera will add their own improvements and innovations." More information about the camera is published in the Journal of Ophthalmology.

Trials for Harmoni Modular IOL are fully enrolled

Feasibility trials for the Harmoni Modular IOL System (ClarVista Medical, Alisa Viejo, California) are now fully enrolled, according to a company press release. The trials include 175 patients; results from preliminary analyses are promising, the company reported. Further results will be analyzed as the Harmoni Modular IOL works toward a U.S. pivotal trial. ClarVista plans to submit an investigational device exemption to the FDA in the second quarter of this year. Clinical evidence for Harmoni now spans more than 250 patients and 3 years of follow up.

Phase I/II clinical trial for retinitis pigmentosa gene therapy begins

A Phase I/II clinical trial to treat patients with X-linked retinitis pigmentosa (XLRP) has begun to enroll and dose patients. The treatment is a gene therapy developed by NightstaRx Ltd. (London, United Kingdom). The gene therapy approach uses the viral vector adeno-associated virus to develop a codon-optimized copy of the retinitis pigmentosa GTPase regulate gene into the cells. The multicenter, open-label, dose-escalation study is designed to enroll 24 or more male patients in the U.K., according to a company press release. Each patient will receive a subretinal injection of adeno-associated virus-XLRPGR gene therapy, with the goal of assessing safety and tolerability over a year.


  • Seven or more intravenous injections of bevacizumab (Avastin, Genentech, South San Francisco) a year is associated with a higher risk for glaucoma surgery, according to a newly published study, led by Brennan D. Eadie, MD, PhD. The case-control study tracked data from large population-based databases supported by Canada's British Columbia Ministry of Health. The patients included all received intravitreal bevacizumab injections for exudative age-related macular degeneration between 2009 and 2013. For every case, investigators identified 10 controls and matched for age, preexisting glaucoma, calendar time, and follow-up time. Seventy-four cases of glaucoma surgery were identified; the adjusted rate ratio of glaucoma surgery in those receiving seven or more injections annually was 2.48. "There was a 10.3% higher number of seven or more injections among cases with controls," the investigators wrote. There was a nonstatistically significant rate ratio in the same direction in patients who received four to six injections a year of bevacizumab. The study is published in JAMA Ophthalmology.
  • A recent study found lower mean cumulative dissipated energy (CDE) values with an active-fluidics phacoemulsification platform than with a gravity-fluidics platform used with conventional cataract extraction. The use of femtosecond laser pretreatment with active-fluidics reduced CDE further, reported lead investigator Nilufer Yesilirmak, MD. The prospective, comparative, nonrandomized study included 570 eyes (570 patients) scheduled for femtosecond laser-assisted cataract surgery with the LenSx (Alcon, Fort Worth, Texas) platform or conventional phacoemulsification using an active-fluidics torsional platform (Centurion, Alcon) or torsional platform (Infiniti, Alcon). The mean CDE (percent-seconds) in the femtosecond cases was 5.18, compared with 7.77 in conventional cases. In both fluidics platforms, the mean CDE lowered significantly in the femtosecond group compared with the conventional group. The study is published in the Journal of Cataract & Refractive Surgery.
  • About 20% of youths with type 1 diabetes and 7.2% with type 2 diabetes developed diabetic retinopathy over a median follow up of 3.2 and 3.1 years, respectively. Led by Sophia Y. Wang, MD, investigators used their retrospective research to track diabetic retinopathy in youths under the age of 21 who were enrolled in a large U.S. managed care network. A total of 2,240 youths were included. Current guidelines recommend that ophthalmic screening begin 3 to 5 years after an initial diabetes diagnosis, the investigators wrote; however, at that point in the study, more than 18% of the young persons analyzed with type 1 diabetes had already received a diabetic retinopathy diagnosis. Young persons with diabetes should undergo regular eyecare screenings to ensure a timely diabetic retinopathy diagnosis, the investigators concluded. The study is published in Ophthalmology.
  • A sustained-release dexamethasone intracanalicular insert (Dextenza, Ocular Therapeutix, Bedford, Massachusetts) was associated with overall patient satisfaction, convenience, and comfort, according to a study that was part of a Phase III trial program. Of 25 patients interviewed, 92% reported the highest level of satisfaction, 96% described their experience with the insert as convenient, and the same percentage rated their experience as very or extremely convenient compared with previous topical therapy. All patients said the insert was comfortable. Eighty-four percent said they would be willing to pay more for the insert than for eye drop therapy. The study is published in Patient Preference and Adherence.


  • Restasis (cyclosporine ophthalmic emulsion 0.05%, Allergan, Dublin, Ireland) Multidose is now available. Restasis Multidose is the same formulation as regular Restasis, but the latest version allows for multidoses versus single-dose vials.
  • Novaliq (Heidelberg, Germany) has entered into a strategic licensing agreement with AFT Pharmaceuticals (New Zealand) for the commercialization of Novaliq's NovaTears for evaporative dry eye in Australia and New Zealand.

This issue of EyeWorld Weekly Update was edited by Amy Goldenberg and Vanessa Caceres.

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 Donnenfeld, MD, chief medical editor; Rosa Braga-Mele, MD, cataract editor; Clara Chan, MD, cornea editor; Nathan Radcliffe, MD, glaucoma editor; and Vance Thompson, MD, refractive editor.

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