Avedro resubmits CXL system 

Avedro (Waltham, Mass.) has resubmitted its riboflavin ophthalmic solution/KXL System to the U.S. Food and Drug Administration for the treatment of progressive keratoconus or corneal ectasia following refractive surgery, the company announced. Avedro anticipates an application action date in March 2015, and said the resubmission is a comprehensive reply to questions and requests from the March 2014 complete response letter.

The proposed indications were both granted orphan status by the FDA in 2011. If approved, riboflavin ophthalmic solution/KXL System would be the first FDA-approved therapeutic treatment for these orphan indications. 

FDA approves Iluvien

The Food and Drug Administration has granted approval to Iluvien (fluocinolone acetonide intravitreal implant) 0.19 mg for the treatment of diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure, developer Alimera Sciences (Atlanta) said.

Each Iluvien implant is designed to release sub-microgram levels of fluocinolone acetonide for 36 months. The Iluvien approval was based on clinical trial data that showed that at month 24 after receiving the Iluvien implant, 28.7% of patients (P=.002) experienced an improvement from baseline in their best corrected visual acuity on the Early Treatment Diabetic Retinopathy Study eye chart of 15 letters or more.

Alimera expects to launch Iluvien in the U.S. during the first quarter of next year. 

FDA removes lens status
restriction on Ozurdex

The Food and Drug Administration has revised its approval of Ozurdex (dexamethasone intravitreal implant 0.7 mg, Allergan, Irvine, Calif.) to now include the general diabetic macular edema patient population, Allergan said.

The implant's original approval in June limited use to pseudophakic patients or those scheduled to undergo cataract surgery.

A twice-daily sub-micron gel formulation of loteprednol etabonate was statistically superior to placebo in eliminating inflammation and pain following cataract surgery by study day 8, the primary endpoints in the first phase 3, multicenter, double-masked, vehicle-controlled, parallel-group study, developer Bausch + Lomb (Bridgewater, N.J.) said in a news release.

The new gel formulation features a sub-micron particle size and a lower concentration of loteprednol etabonate (0.38%) than the company's currently marketed Lotemax (loteprednol etabonate ophthalmic gel 0.5%).

In the 4-arm study, 514 patients undergoing cataract surgery at 47 clinical sites across the United States were randomized to receive either sub-micron loteprednol etabonate ophthalmic gel (0.38%) or a vehicle gel in 4 treatment groups, either 3 times daily or 2 times daily, for approximately 14 days. The primary efficacy endpoints were the proportion of patients with complete resolution of anterior chamber cells in the study eye at day 8 and the proportion of subjects with Grade 0 pain in the study eye at day 8.

A second study is underway, and B+L expects to file for U.S. regulatory approval in mid-2015.

Bionic eye successfully completes
first RP study

A clinical trial of a prototype 24-channel percutaneous implant in patients with profound vision loss from the eye disease retinitis pigmentosa (RP) has been successfully completed, Bionic Vision Australia (Melbourne) said in a news release.

The 2-year Prototype 24-Channel Percutaneous Connector Study, which started in May 2012, involved 3 RP patients with profound vision loss (bare light perception only) who each received surgically implanted suprachoroidal electrode implants to aid the restoration of vision. Surgery was completed without any adverse events.

Over the course of the study, the implants remained "remarkably" stable, the researchers said, with no significant movement, and were shown to be safe with no unexpected device-related serious adverse events observed. Although this was designed to be primarily a proof-of-concept and safety study, the trial also generated efficacy data showing that the device improved patients' ability to see light and shapes, and helped with navigation around obstacles and detection of items on a tabletop search task.

RESEARCH BRIEFS

• In pseudoexfoliation glaucoma, a triple procedure comprising phacoemulsification, Trabectome (NeoMedix, Tustin, Calif.), and trabecular aspiration is more effective than phaco and trabecular aspiration alone, according to R.A. Widder and colleagues. The group used a case-matched retrospective study design to include 30 patients into the two groups. Mean follow-up was 15 months in both groups. Intraocular pressure decreased from 25.3±6.3 mmHg to 14.4±3.7 mmHg (p<0.0001) in the triple procedure group and from 25.3±4.2 mmHg to 18.1±4.2 mmHg (p<0.0001) in the control group. The difference between groups was also statistically significant. The reduction in medication scores did not differ between groups. The study is published in Graefe's Archives of Clinical and Experimental Ophthalmology.
• Corneal collagen crosslinking (CXL) seems to be effective and safe in halting progression of keratoconus over a long-term follow-up period up to 5 years postoperatively, according to G.D. Kymionis and colleagues on behalf of the Cretan study group. In this prospective, interventional case series, patients with progressive keratoconus underwent CXL treatment according to the Dresden protocol. Visual, refractive, and topographic outcomes along with endothelial cell density were evaluated preoperatively and at 1, 2, 3, 4, and 5 years postoperatively. A total of 21 patients (25 eyes) were enrolled, with a mean follow-up of 43.7 months. Logarithm of the minimum angle of resolution (logMAR) mean uncorrected visual acuity and the mean best spectacle corrected visual acuity improved significantly from 0.92±0.54 and 0.29±0.21 preoperatively to 0.63±0.41 (P=0.010) and 0.18±0.18 (P=0.011), respectively, at the last follow-up. Mean steep and mean flat keratometry readings were reduced significantly from 52.53±6.95 D and 48.11±5.98 D preoperatively to 49.10±4.50 D (P<0.001) and 45.58±3.81 D (P=0.001), respectively, at the last follow-up. Mean endothelial cell density did not differ significantly at any postop interval. The study is published in Cornea.
• The Mplus X (Topcon Europe Medical, Capelle aan den IJssel, the Netherlands) provides a good visual outcome at distance and near with minimal dysphotopsia. E.J. Berrow and colleagues assessed the visual performance and subjective experience of 17 patients (mean age: 64) who underwent binocular implantation with the Mplus X. Mean residual manifest refraction was -0.13+0.51 D. Twenty-five eyes (74%) were within a mean spherical equivalent of -0.50 D. Mean uncorrected distance visual acuity was +0.10+0.12 logMAR monocularly and 0.02-0.09 logMAR binocularly. Thirty-two eyes (94%) could read 0.3 or better without any reading correction and all patients could read 0.3 or better with a reading correction. The study is published in the Journal of Refractive Surgery.

NEW PRODUCT BRIEFS

• Avellino Lab (Menlo Park, Calif.) earlier this year introduced its DNA Dual Test for LASIK Safety genetic test, the company said. The test detects for both Avellino corneal dystrophy and granular corneal dystrophy type 1 (GCD1). The company notes people with GCD1 who undergo laser vision correction surgery are at "extreme risk" of experiencing eventual blindness.