EW Weekly, October 7, 2016

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October 7, 2016
Volume 21 , Number 36

OTX-TP starts Phase 3 study enrollment

Ocular Therapeutix (Bedford, Massachusetts) has enrolled its first patient in two planned Phase 3 clinical studies evaluating OTX-TP (sustained release travoprost) for the treatment of glaucoma and ocular hypertension. OTX-TP is a preservative-free drug product candidate that resides within the canaliculus and is designed to deliver the prostaglandin analog travoprost to the ocular surface for up to 90 days. The U.S.-based, prospective, multicenter, randomized, parallel-arm, placebo-controlled study is expected to enroll approximately 550 patients with open-angle glaucoma or ocular hypertension at 50 clinical sites. The Phase 3 study design will not include a timolol comparator or validation arm, and will not have active or placebo eye drops administered in either arm. The comparator arm will, however, use a non-drug eluting hydrogel-based intracanalicular insert. The primary efficacy endpoint will be statistically superior reduction of IOP from baseline with OTX-TP compared to placebo at 2, 6, and 12 weeks following insertion.

Last patient enrolled in non-PDR Luminate study

A Phase 2b study evaluating the safety and efficacy of Luminate (ALG-1001) in inducing posterior vitreous detachment (PVD) in patients with non-proliferative diabetic retinopathy (DR) has enrolled its last patient, developer Allegro Ophthalmics (San Juan Capistrano, California) said in a press release. Top-line results from this study (DEL MAR) in patients with diabetic macular edema are expected during the fourth quarter in 2016, the company said, with top-line results from the Phase 2 PACIFIC study expected in the first half of 2017. Luminate is a first-in-class integrin peptide therapy that treats vitreoretinal diseases by targeting integrin receptors involved in cell signaling and regulation and in the construction of new and aberrant blood vessels.

Aflibercept/rinucumab combo failed to meet endpoints

A Phase 2 study evaluating aflibercept co-formulated with rinucumab, an anti-platelet-derived growth factor receptor beta antibody, in patients with neovascular age-related macular degeneration (wet AMD), failed to meet its endpoints in a Phase 2 study, developer Regeneron (Tarrytown, New York) said in a press release. The combination therapy did not demonstrate an improvement in best corrected visual acuity (BCVA) compared to intravitreal aflibercept injection monotherapy at 12 weeks, the primary endpoint of the study. At 12 weeks, patients in both combination aflibercept/rinucumab groups showed a 5.8 letter improvement in BCVA. Efficacy reports were consistent across "all choroidal neovascularization subtypes," Regeneron said.

Tocilizumab granted "breakthrough therapy" designation

The Food and Drug Administration (FDA) has granted breakthrough therapy designation status to Actemra (tocilizumab) for giant cell arteritis (GCA), a chronic, potentially life-threatening autoimmune condition, developer Genentech (South San Francisco) said in a press release. The Phase 3 GiACTA study showed that Actemra, initially combined with a 6-month steroid (glucocorticoid) regimen, more effectively sustained remission through 1 year compared to a 6- or 12-month steroid-only regimen in people with GCA. Full data will be presented at an upcoming meeting this year, the company added.

Katena acquires Eagle Vision

Katena Products (Denville, New Jersey) will purchase Eagle Vision, a leading developer of punctal plug technology, Katena announced in a press release. Details of the acquisition were not available.

Moorfields sells pharma unit to Rayner

Moorfields Eye Hospital NHS Foundation Trust (London) has sold its commercial pharmaceutical business, Moorfields Pharmaceuticals, to the ophthalmic manufacturer Rayner Pharmaceuticals Limited (Worthing, United Kingdom), Moorfields said in a news release. Rayner is a British company and the only manufacturer of IOLs in the U.K. Rayner has been operating for more than 100 years and currently sells to more than 80 countries around the world.

RESEARCH BRIEF

  • Performance on the Eyesi simulator (VRmagic, Mannheim, Germany) is "significantly and highly correlated to real-life surgical performance for patients undergoing cataract surgery," according to a study. A.S. Thomsen and colleagues evaluated the correlation in performance of cataract surgery in 11 surgeons between a virtual reality simulator and real-life surgery using two objective assessment tools with evidence of validity. After a designated warm-up period, the proficiency-based test on the Eyesi simulator was strongly correlated to real-life performance measured by motion-tracking software of cataract surgical videos with a Pearson correlation coefficient of -0.70 (p=0.017). The study is published in Acta Ophthalmologica.
  • A new study in the Journal of Cataract & Refractive Surgery found extended range of vision IOLs provided successful visual restoration across all distances after cataract surgery, with a minimal level of disturbing photic phenomena and high levels of patient satisfaction. Beatrice Cochner, MD, and the Concerto Study Group analyzed clinical outcomes after implantation of an extended range of vision IOL, the Tecnis Symfony (Abbott Medical Optics, Abbott Park, Illinois), in a routine clinical setting. The study comprised 411 patients who had bilateral implantation of the extended range of vision IOL, with intended micro-monovision in one group (monovision group) and intended emmetropia in the other group (non-monovision group). The monovision group comprised 112 patients and the non-monovision group, 299 patients. The mean decimal uncorrected distance (UDVA), intermediate (UIVA), and near (UNVA) visual acuities were 0.95, 0.81, and 0.69, respectively, at 4 to 6 months postoperatively. Significantly better UIVA (P=.003) and UNVA (P=.011) were found in the monovision group than in the non-monovision group. Spectacle independence was high, with 14.4% of eyes requiring reading spectacles frequently. More than 90% of patients reported no or mild halos, glare, starbursts, or other photic phenomena. Patient satisfaction scores (median) for distance, intermediate, and near vision were 9.0, 10.0, and 8.0, respectively. The satisfaction score for near vision increased to 9.0 in the monovision group. More than 91% of patients said they would recommend the same procedure to their friends and family.
  • D. López-Alcón and colleagues attempted to find plausible predictors among optical parameters that may explain the inter-individual differences in subjective amplitude of accommodation not explained by age. An exploratory multivariable regression analysis was carried out retrospectively on a dataset with 180 eyes from 97 subjects (ages ranged from 20 to 58 years). Subjective amplitudes of accommodation were recorded with the use of a custom-made Badal system. A commercial aberrometer was used to obtain each eye's wavefront during the full range of accommodation. The plausible predictors under study were pupil diameter in the unaccommodated eye, its reduction with accommodation; fourth- and six-order Zernike spherical aberration, their reduction with accommodation, and subjective refraction. At a significance level of 0.05, only fourth- and sixth-order Zernike spherical aberration were found to be predictors of subjective amplitude of accommodation not explained by age, each explaining on their own less than 5% of the variance and about 9% together. All other optical parameters explained less than 2%. Spherical aberration did not explain the greater variability for younger eyes than for older eyes. The remainder variability in amplitude of accommodation not explained by age or spherical aberration was about ±2.6 D for 20-year-old subjects, ±1.5 D for 40-year-old subjects, and about ±0.6 D for 55-year-old subjects. Optical factors do not seem to account for much of the inter-individual differences in subjective amplitude of accommodation. Most of the variability not explained by age must be due to anatomical differences and physiological, psychological, or other factors. The study is published in Vision Research.
 

NEW PRODUCT BRIEF

  • Heidelberg Engineering (Heidelberg, Germany) will launch the Spectralis OCT Glaucoma Module Premium Edition at the 2016 American Academy of Ophthalmology conference, the company said. The Spectralis OCT Glaucoma Module Premium Edition provides a comprehensive analysis of the optic nerve head, retinal nerve fiber layer, and ganglion cell layer by precisely matching unique scan patterns to the fine anatomic structures relevant in glaucoma diagnostics, the company said.

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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