EW Weekly, April 11, 2014

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April 11, 2014
Volume 19 , Number 10

FDA approves VuPad

The Sonomed Escalon VuPad, a tablet-based ultrasound imaging system, has received 510(k) marketing clearance from the Food and Drug Administration, said Escalon Medical Corp. (Ardmore, Pa.).
The VuPad combines ultrasound biomicroscopy and newly enhanced B-scan image quality with an ultra high-resolution screen that has a 25% larger viewing area than other portable ultrasound devices, the company said.

Novaliq starts phase 1 topical cyclosporin study

Novaliq (Heidelberg, Germany) has started a phase 1 study for CyclASol (cyclosporin solution) following U.S. and European patent approval of the solution for the treatment of dry eye syndrome, the company said.
Other cyclosporin formulations are emulsions, but CyclASol is “the first and only 0.05% clear cyclosporin solution,” according to Novaliq, adding the solution has both long-term stability and superior claims when compared to conventional emulsions.

SAKURA meets phase 3 endpoint in NI-PSU study

SAKURA (Study Assessing double‐masKed Uveitis tReAtment) met its primary endpoint of the proportion of patients achieving a vitreous haze score of 0 at month 5, developer Santen (Emeryville, Calif.) said in a news release.
SAKURA is the first of two global phase 3 studies evaluating intravitreal injections of sirolimus in patients with non-infectious posterior segment uveitis (NI-PSU). There are currently no non-steroidal treatments for NI-PSU.
SAKURA is an ongoing multinational, multicenter, randomized, double-masked study assessing the safety and efficacy of sirolimus. A total of 347 patients with non-infectious posterior, intermediate or panuveitis were enrolled at approximately 150 sites for this first SAKURA study. Eligible patients were randomized into three treatment arms, each receiving different doses of sirolimus by intravitreal injection. Sirolimus is an mTOR inhibitor, an immunomodulator already approved for use in renal transplant patients and for improving coronary luminal diameter in patients with symptomatic ischemic disease.

First patient enrolled in RP study

A phase 1b/2, multicenter, randomized, double-masked, placebo-controlled study that aims to assess the safety and potential efficacy of rhNGF (recombinant human Nerve Growth Factor) eye drops in two doses (60 and 180 g/ml) compared to a placebo in the treatment of retinitis pigmentosa (RP) has enrolled its first patient, developer Domp (Milan, Italy) said. The Lumos study will enroll 50 patients, with a 24-week follow-up.
The molecule was part of the research of Nobel Prize winner Rita Levi Montalcini, and has recently received orphan drug designation from the European Medicines Agency (EMA) and the United States FDA regulatory agencies for the treatment of RP.

Subconjunctival controlled-release latanoprost study on its way

ViSci (Tel Aviv, Israel) has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration to conduct a phase 1/2a clinical study with its subconjunctival latanoprost controlled-release insert for the treatment of glaucoma, parent company BioLight Israeli Life Sciences said.
The 3-month study in 68 glaucoma patients is designed to prove the safety and efficacy of different doses of the insert containing its proprietary form of latanoprost. If the FDA approves the study, ViSci plans to enroll seven sites throughout the U.S.

Leica, TruVision expand partnership

TruVision 3D Surgical (Wetzlar, Germany) and Leica Microsystems (Santa Barbara, Calif.) have expanded their partnership to include Leica’s entire line of ophthalmic microscopes. Their alliance last year resulted in “the first surgical microscope integrated with TrueVision’s 3D intelligent visualization technology for neurosurgery,” the groups said.

RESEARCH BRIEFS

  • Adherence to the Mediterranean dietary pattern (MeDi) was not associated with a beneficial effect on dry eye syndrome (DES), according to a study. A. Galor and colleagues enrolled 247 men with normal eyelid, corneal, and conjunctival anatomy. The patients filled out the 2005 Block Food Frequency Questionnaire and the Dry Eye Questionnaire 5 and underwent measurement of tear film parameters. The serum level of 25-hydroxy vitamin D was also measured. Adherence to the MeDi was positively associated with the risk of having DES (P=0.007) and with increasing disease severity. Higher levels of vitamin D were associated with decreased DES symptoms, with a 1.24 decrease in median Dry Eye Questionnaire 5 score for every 10-U increase in vitamin D levels (P=0.01). The study is published in Cornea.
  • Many patients who do not reach their target IOP on latanoprost can achieve additional IOP lowering and maintain monotherapy by replacing latanoprost with bimatoprost, according to Jonathan S. Myers, MD, and colleagues. They conducted two prospective, investigator-masked, randomized, parallel-group, multicenter studies enrolling patients with baseline IOP ≥20 mmHg after ≥30 days of latanoprost 0.005% monotherapy. Patients were randomized to 12 weeks of study treatment (study 1, bimatoprost 0.01% once daily or bimatoprost 0.01% once daily plus brimonidine 0.1% three times daily; study 2, bimatoprost 0.03% once daily or bimatoprost 0.03% once daily plus fixed-combination brimonidine 0.2%/timolol 0.5% twice daily). In both treatment arms, mean reduction in intraocular pressure from latanoprost-treated baseline was statistically significant at each time point at both follow-up visits (P<0.001). Mean percentage IOP reduction from latanoprost-treated baseline was numerically greater with bimatoprost 0.01% than with bimatoprost 0.03% throughout follow-up. The study is published in Clinical Ophthalmology.
  • Rituximab was safe and effective in 7 of 10 patients with noninfectious orbital disease, although 4 required reinfusion with rituximab to maintain control of orbital inflammation, according to a small study. E. Suhler and colleagues conducted a dose-ranging, randomized, double-masked phase 1/2 clinical trial on 10 patients with orbital inflammation refractory to systemic corticosteroids and at least 1 other immunosuppressive agent. Rituximab infusions were administered on study days 1 and 15 at doses of either 500 mg or 1000 mg. Initial responders with recurrent inflammation after week 24 were permitted reinfusion with an additional cycle of two open-label 1000-mg rituximab infusions. Of 10 enrolled patients, 7 demonstrated improvement on the orbital disease grading scale at the 24-week endpoint with rituximab therapy. Of these 7 individuals, 4 were receiving corticosteroids at study inception and all achieved successful dose reduction. For the secondary outcome measures in the 10 participants, 7 patients and 8 patients improved in self-rated and physician global health scores, respectively, and 7 patients had reduction in pain by 25% or more at 24 weeks. Four patients who were positive responders at the week 24 endpoint experienced breakthrough inflammation after week 24 and received reinfusions between 24 and 48 weeks. Vision remained stable in all participants. The study is published in JAMA Ophthalmology.

NEW PRODUCT BRIEFS

  • Volk (Mentor, Ohio) introduced the Pictor Plus portable ophthalmic camera in the U.S. and Canada. The 1-lb. camera was designed to shoot “detailed, high-res images in daylight or darkness,” Volk said.

EYEWORLD WEEK Online is edited by Stacy Majewicz and Michelle Dalton.

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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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