EW Weekly, November 18, 2016

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November 18, 2016
Volume 21 , Number 42

Dextenza topline Phase 3 trialresults deemed successful

A Phase 3 study of Dextenza (dexamethasone insert) 0.4 mg for the treatment of post-surgical ocular inflammation and pain has achieved positive topline results, developer Ocular Therapeutix (Bedford, Massachusetts) said in a press release. The trial successfully met its two primary efficacy endpoints for inflammation and pain, achieving statistically significant differences between the treatment group and the placebo group for the absence of inflammatory cells on day 14 and the absence of pain on day 8, respectively. According to the company, 52.3% of patients treated with Dextenza showed an absence of inflammatory cells in the anterior chamber of the study eye on day 14, compared to 31.1% of those receiving the placebo vehicle control punctum plug ( p<0.0001). Further, 79.6% of patients treated with Dextenza reported absence of pain in the study eye on day 8, compared to 61.3% of those receiving the placebo vehicle control punctum plug ( p<0.0001). Dextenza is a bioresorbable intracanalicular insert designed for drug release to the ocular surface for up to 30 days. The company plans to resubmit its NDA for Dextenza for the post-surgical ocular pain indication by the end of the year and, subject to potential approval, will submit an NDA supplement for Dextenza to include a post-surgical ocular inflammation indication.

Actemra "superior" to steroids in GCA

A Phase 3 study on Actemra (tocilizumab) in people with giant cell arteritis (GCA) found the compound met its primary and secondary endpoints, developer Genentech (South San Francisco) said in a news release. Actemra, initially in combination with a 6-month steroid (glucocorticoid) taper, enabled significantly more patients to achieve sustained disease remission at 1 year (56% [ p<0.0001] and 53.1% [ p<0.0001]) versus 14% with a 6-month steroid taper regimen given alone. A 104-week open label extension study from GiACTA is still ongoing. Data from this analysis will quantify Actemra's long-term safety and maintenance of efficacy beyond 1 year, as well as any potential long-term steroid-sparing effects.

THC-based compound shows efficacy in IOP-lowering

A multiple day regimen of Δ9-THC-valine-hemisuccinate has shown NB1111 lowered IOP in a normal eye in a statistically significant manner with peak IOP decline of 32% versus 16% for pilocarpine and 23% for timolol ( p<0.05), developer Nemus Bioscience (Costa Mesa, California) said in a press release. Data further showed in earlier experiments in a glaucomatous eye that NB1111 lowered IOP by 45%. Use of Δ9-THC (parent molecule, non-prodrug), whether formulated in an emulsion or solid lipid nanoparticle (SLN) eye drop solution, resulted in no significant tissue concentration or decline in IOP. The formulation of NB1111 into an SLN produced a duration of activity that could be consistent with twice-daily eye drop dosing in humans, successfully transported the drug into both the anterior and posterior compartments of the eye, and was highly significant compared to both approved comparator drugs ( p<0.001), Nemus added. There were no safety issues identified during the 5 days of dosing, and no free THC was detected in the peripheral circulation of the test animals after repeated dosing. Additionally, the NB1111 studies examined the effect on drug half-life by encapsulating NB1111 in an SLN with single- and multiple-day dosing for up to 5 days. The company will "further explore the neuroprotective effects of cannabinoids upon the optic nerve and move the ophthalmology program into human testing."

ReCLAIM study started

A Phase 1 study evaluating elamipretide in intermediate dry age-related macular degeneration (AMD), dubbed the ReCLAIM study, is now enrolling patients, developer Stealth BioTherapeutics (Boston) said in a press release. Top-line results are expected by mid-2017. ReCLAIM is an open-label study to evaluate the safety and tolerability of 12 weeks' treatment with daily subcutaneous injections of elamipretide in patients, age 55 and above who have at least one eye with intermediate AMD, and have either: a) high-risk protein deposits (drusen) on the retina without any geographic atrophy (GA), a characteristic of advanced AMD that can result in the loss of photoreceptor cells, or b) GA with an unaffected central fovea (non-central GA). The study's primary endpoints are safety and tolerability, and the secondary endpoints are changes from baseline in physical/ophthalmic examinations and feasibility of subcutaneous injections in this patient population. In laboratory models, elamipretide appears to prevent mitochondrial dysfunction in the retinal pigment epithelium.

Avellino to introduce keratoconus screening test in 2017

A genetic keratoconus screening test will be launched in early 2017, according to Avellino Labs (Menlo Park, California). In a recent study, Avellino Labs used state-of-the-art next generation sequencing (NGS) to examine DNA collected from more than 200 keratoconus patients from different clinics and institutions around the world. The company was able to identify four DNA variants within three different genes that conferred genetic risk factors in 9% to 21% of patients within the study group from Korea. These percentages imply a statistically significant increased risk for keratoconus. Avellino Labs intends to launch a test to screen for these four mutations for use in Korea, Japan, and China in the first quarter of 2017.

RESEARCH BRIEFS

  • Smartphone use by children was strongly associated with pediatric dry eye disease (DED); however, outdoor activity appeared to be protective against the disorder, according to J.H. Moon and colleagues. In Korea, where the study originated, 83% of children and 89.8% of adolescents use smartphones. The researchers enrolled 916 children and analyzed them as DED vs. control, urban vs. rural, younger grade (1st to 3rd) vs. older grade (4th to 6th). A total of 6.6% of children were included in the DED group, and 8.3% of children in the urban group were diagnosed with DED compared to 2.8% in the rural group (P=0.03). The rate of smartphone use was 61.3% in the urban group and 51.0% in the rural group (P=0.04). In total, 9.1% of children in the older-grade group were diagnosed with DED compared to 4% in the younger-grade group (P=0.03). The rate of smartphone use was 65.1% in older-grade children and 50.9% in younger-grade children (P<0.001). The mean daily duration of smartphone use was longer in the DED group than controls (logistic regression analysis, P<0.001, OR=13.07), and the mean daily duration of outdoor activities was shorter in the DED group than controls (logistic regression analysis, P<0.01, OR=0.33). After cessation of smartphone use for 4 weeks in the DED group, both subjective symptoms and objective signs had improved. The study is published in BMC Ophthalmology.
  • Femto-LASIK improves uncorrected distance visual acuity (UDVA) better than photorefractive keratectomy with mitomycin-C (PRK-MMC) in high myopia, according to H. Hashemi and colleagues. Their comparative nonrandomized trial enrolled 60 eyes (30 eyes in each group) and found at 6 months after surgery, UDVA showed an improving trend, but it was better in the femto-LASIK group (P=0.026). Corrected distance visual acuity in the two groups remained similarly unchanged, and safety and efficacy indices were not statistically different. Contrast sensitivity was significantly decreased in the femto-LASIK group compared with the PRK-MMC group (P=0.016) in contrast sensitivity 18 only. Changes in the ocular and corneal higher order aberrations were not statistically different between the two groups except ocular coma, which increased in the femto-LASIK group (P=0.041). The study is published in Eye & Contact Lens.
  • Although backscattered light from deeper retinal layers can have an effect on objective scatter index (OSI), the double-pass image provides information to grade different types of cataract when assessing these eyes for treatment, according to Meritxell Vilaseca, PhD, and colleagues. Their prospective, observational case series comprised eyes diagnosed with nuclear, cortical, or posterior subcapsular cataracts and healthy eyes (control group). Patient examinations included assessment of the manifest subjective refraction, corrected distance visual acuity, contrast sensitivity, and cataract grade using the Lens Opacities Classification System III (LOCS III) score. Significant correlations with LOCS III classification were found in terms of log(s) and OSI, although they were slightly stronger with OSI for all cataract types, which could be attributable to higher order aberrations. The OSI and straylight (log[s]) shared approximately 44% of the scattering estimation and to coincide on the visual function decline with scattering for the three cataract types evaluated. Limits to discriminate between healthy and cataractous eyes and sensitivity and specificity values were 1.15 (sensitivity 91%, specificity 100%) for log(s) and 1.18 (sensitivity 89%, specificity 100%) for OSI (P<.05). The study is published in the Journal of Cataract & Refractive Surgery. 

NEW PRODUCT BRIEF

  • Tobii Pro (Stockholm, Sweden) launched the Tobii Pro Spectrum and Tobii Pro Lab, the company's "most advanced eye tracking solutions to date." The new eye tracking platform can collect data at up to 600 Hz while still accommodating natural head movements, the company said. Tobii Pro Lab enables the combination of visual attention data with other physiological measurements such as EEG (brain activity), GSR (sweat production due to emotions or stress), and ECG (heart activity).

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: 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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