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Volume 17, Number 5
February 13, 2012
FDA clears second generation LipiFlow
FDA approves Mitosol for glaucoma
FDA grants priority review to ocriplasmin
FDA OKs stem cell dry AMD trial
Synthetic hydrogel polymer enters pivotal clinical trial
Retinal prosthesis shows promising interim results
LCA gene therapy improves vision
Iridex, Cutera finalize aesthetic business unit sale

FDA clears second generation LipiFlow

The Food and Drug Administration has granted approval for the LipiFlow Thermal Pulsation System (TearScience, Morrisville, N.C.), a medical device that treats evaporative dry eye by liquefying and evacuating obstructions in meibomian glands located in the eyelids, TearScience said in a news release. The updated version includes the ability to treat both eyes simultaneously. TearScience plans to introduce the device in March and will upgrade physicians using the current version.

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FDA approves Mitosol for glaucoma

Mitosol, a system for delivering antifibrotic agents in glaucoma, refractive, and corneal surgery, received its first approval from the Food and Drug Administration, developer Mobius (St. Louis, Mo.) said in a press release. The initial approval is for the use of Mitosol in glaucoma surgery; Mitosol “provides a new system for delivering a precise dose of its active ingredient, mitomycin-C, to ophthalmic surgeons for use in procedures without any change to their current technique,” Mobius said.

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FDA grants priority review to ocriplasmin

The Food and Drug Administration intends to grant ThromboGenics (Leuven, Belgium) priority review to the company’s ocriplasmin for the treatment of symptomatic vitreomacular adhesion, including macular hole, the company said. As a result of the decision, the company will withdraw its current filing for standard review filed just last month. It plans to resubmit a priority review resubmission by April.

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FDA OKs stem cell dry AMD trial

The Food and Drug Administration has authorized the initiation of a Phase I/II clinical trial of StemCells’ (Newark, Calif.) proprietary HuCNS-SC product candidate (purified human neural stem cells) in dry age-related macular degeneration (AMD), the company said.
The Phase I/II trial will be an open-label, dose-escalation study and is expected to enroll a total of 16 patients. The HuCNS-SC cells will be administered by a single injection, and patients’ vision will be evaluated at set time points over a 1-year period. Patients will then be followed for an additional 4 years in a separate observational study.  Preclinical data has shown HuCNS-SC cells “protect host photoreceptors and preserve vision in a well-established animal model of retinal disease that is relevant to dry AMD,” the company said. The transplants significantly protect against the degeneration of photoreceptors, and the number of cone photoreceptors remains constant over an extended period, consistent with the sustained visual acuity and light sensitivity observed. In humans, degeneration of the cone photoreceptors account for the unique pattern of visual loss in dry AMD, the company said.

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Synthetic hydrogel polymer enters pivotal clinical trial

U.S. regulators granted approval for a pivotal trial on ReSure Sealant, a proprietary synthetic hydrogel polymer for ophthalmic use over clear corneal incisions, said developer Ocular Therapeutix (Bedford, Mass.).
The randomized, parallel-arm clinical trial will test the safety and efficacy of the device, relative to suture closure, for prevention of post-op fluid egress on clear corneal incisions following cataract or intraocular lens placement surgery. The trial will be conducted at up to 24 sites throughout the U.S., the company said. ReSure Sealant is a synthetic hydrogel polymer that is applied as a liquid and gels in situ on the ocular surface, creating a soft and lubricious surface barrier. The Sealant is designed to stay on the incision in the immediate post-op period, after which it gently sloughs off in the patient’s tears, the company said.

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Retinal prosthesis shows promising interim results

A single-arm, controlled, prospective, multicenter clinical trial of a retinal prosthesis showed “positive interim results,” developer Second Sight Medical (Lausanne, Switzerland) said in a news release. The Argus II Retinal Prosthesis has been available in Europe since Feb. 2011 and to date is the only retinal prosthesis to be approved.
The results from the trial demonstrated long-term reliability and showed that the previously blind subjects (n=30) performed better at visual tasks after being implanted with the Argus II system. The best visual acuity achieved by a subject in this study was 1.8 logMAR (Snellen equivalent, 20/1262), “a substantial visual improvement over blindness,” the company added.
A total of 30 patients were implanted with the prosthesis and followed for a minimum of 6 months and up to 2.7 years at the time the article was authored. Three types of visual acuity tests were performed using computer monitors: square localization, direction of motion, and grating visual acuity. The Argus II works by converting video images captured from a miniature camera, housed in the patient’s glasses, into a series of small electrical pulses that are transmitted wirelessly to an array of electrodes on the epiretinal space. Patients then learn to interpret these visual patterns, thereby gaining some functional vision. The clinical study showed that patients achieved significant gains in visual function, including object detection, improvements in orientation and mobility, letter recognition, and even reading words and sentences in the best cases.

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LCA gene therapy improves vision

Researchers from the University of Pennsylvania have used gene therapy in three adult patients with Leber congenital amaurosis (LCA)—a group of hereditary retinal diseases in which a gene mutation impairs production of an enzyme essential to light receptors in the retina—with initial results indicating the patients who were retreated had improved vision, allowing them to be able to see in dim light, with two able to navigate obstacles in low-light situations. Neither the first treatment nor the re-administered treatment triggered an immune reaction that cancelled the benefits of the inserted genes, as has occurred in human trials of gene therapy for other diseases, the researchers said.
The researchers in the current study previously carried out a clinical trial of this gene therapy in 12 patients with LCA, four of them children aged 11 and younger when they were treated. Exercising caution, the researchers treated only one eye—the one with worse vision. This trial, reported in October of 2009, achieved sustained and notable results, with six subjects improving enough to no longer be classified as legally blind. There were no safety problems and no significant immune responses. The researchers caution that follow-up studies must be done over a longer period and with additional subjects before they can definitively state that re-administering gene therapy for retinal disease is safe in humans.

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Iridex, Cutera finalize aesthetic business unit sale

Iridex (Mountain View, Calif.) has closed the deal with Cutera (Brisbane, Calif.) for the sale of its aesthetic business, the company announced. Iridex plans to concentrate its efforts on its ophthalmic business, the company added.

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RESEARCH BRIEFS

  • Descemet’s stripping automated endothelial keratoplasty (DSAEK) induces fewer anterior surface higher order aberrations (HOAs) but greater posterior surface HOAs than femtosecond laser-assisted penetrating keratoplasty (FLAK) or conventional penetrating keratoplasty (PKP), according to a study by Winston Chamberlain, M.D., and colleagues. The group retrospectively compared consecutive surgical series of 67 eyes of 59 patients between 1.5 and 19 months after corneal transplant surgery (22, 34, and 11 corneas underwent DSAEK, FLAK, and PKP, respectively, by a single surgeon). DSAEK had fewer total anterior HOAs compared with FLAK but greater total posterior HOAs than FLAK and PKP. FLAK had fewer total anterior and posterior HOAs than PKP, but differences were not statistically significant. DSAEK grafts exhibited statistically significantly greater posterior HOAs than either type of PKP. The study is published in Cornea.
  • Using Raman spectra of tears to differentiate between infectious and non infectious ulcerative keratitis should complement the conventional cytological method for rapid diagnosis in the clinician's office, according to a study. Ming-Tse Kuo, M.D., and colleagues applied Raman microspectroscopy using the drop-coating deposition method on Ti/Au-coated glass slides to obtain sample spectra from different human tear groups, including tears from normal subjects and patients with infectious and noninfectious ulcerative keratitis. The differentiation between the infectious and noninfectious keratitis components could be made directly through observation of the normalized tear Raman spectra or the transformed principle scores. The study is published in Investigative Ophthalmology and Visual Science.

NEW PRODUCT BRIEFS

  • Oasis Medical (Glendora, Calif.) introduced its Iris Expander, a 7.0-mm diameter polypropylene ring that expands and maintains access and visibility throughout the surgical procedure. The disposable device is indicated in cases where miosis and intraoperative floppy iris syndrome are present.
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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, M.D., chief medical editor; Bonnie An Henderson, M.D., cataract editor; Edward J. Holland, M.D., cornea editor; Reay H. Brown, M.D., glaucoma editor; Kerry D. Solomon, M.D., refractive editor; and John A. Vukich, M.D., international editor

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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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