EW Weekly, May 24, 2019

Phase 3 glaucoma therapy from Ocular Therapeutix fails to meet endpoint
Although OXT-TP (Ocular Therapeutix) achieved statistically significant reduction in IOP compared with placebo at eight of nine time points in a Phase 3 trial, the treatment failed to meet its primary endpoint, according to a company press release. OTX-TP is an intracanalicular insert delivering a preservative-free formulation of travoprost to reduce IOP in patients with primary open angle glaucoma (OAG) or ocular hypertension. The Phase 3 trial took place at more than 50 sites and included 554 subjects with OAG or ocular hypertension. The primary efficacy endpoint was to achieve a statistically superior mean reduction of IOP from baseline for OTX-TP treated subjects compared with a placebo insert at nine different time points, three diurnal time points, and at 2, 6, and 12 weeks following insertion. The reductions from baseline for OTX-TP treated subjects ranged from 3.27 to 5.27 mm Hg across the nine time points, with a greater reduction at the earlier time points. Company leaders will discuss the results with the U.S. FDA to determine the next steps in the clinical development plans.

Researchers: Glaucoma patients may be at higher risk of vehicle accidents
The car accident rate in patients with moderate glaucoma was almost five times higher than those without glaucoma, according to research presented by Jonathan Myers, MD, Wills Eye Hospital, Philadelphia. The research included 161 patients with a mean age of 64 years with moderate OAG in one eye over 4 years. Patients were asked each year if they were in a motor vehicle accident the previous year. Visual acuity, peripheral vision, and contrast sensitivity all were evaluated. "...[B]etween 5% and 10% of those glaucoma patients were involved in motor vehicle accidents each year despite still having vision good enough to legally qualify for driving,” Dr. Myers said. This compared with a 1.1% rate of motor vehicle accidents for drivers of a similar age. Researchers found that peripheral vision in the worse eye made the biggest difference, suggesting that significant blind spots existed that could have been a liability for driving.

Accelerated development for Orion Visual Cortical Prosthesis System planned
An accelerated plan to develop and commercialize the Orion Vision Cortical Prosthesis System is underway, according to a press release from manufacturer Second Sight Medical. As part of this accelerated plan, the company will add 25 more jobs and focus on advancing Orion while suspending production of its Argus II systems in the near future. Existing Argus II users will still be supported. The Orion is an implanted cortical stimulation device that provides useful artificial vision to individuals who are blind from glaucoma, diabetic retinopathy, optic nerve injury or disease, and eye injury. The device is intended to convert images captured by a miniature video camera mounted on glasses into a series of small electrical pulses.

Clinical hold lifted on ADVM-022 in Phase 1 trial for wet AMD
The U.S. FDA has lifted a clinical hold on ADVM-22 (Adverum Biotechnologies) for the second cohort in the company’s OPTIC Phase 1 trial for wet age-related macular degeneration, allowing dose escalation to 2 x 10^12 vg/eye, according to a company press release. That dose would be three times higher than the dose of 6 x 10^11 vg/eye used in the first cohort. However, based on preliminary responses in the first cohort (n=6), company leaders plan to use a lower dose, 2 x 10^11 vg/eye in the second cohort. The dosing of patients in the study’s second cohort is slated to begin in June. Adverum leaders think that ADVM-022 dosed at 6 x 10^11 vg/eye has shown the potential to provide sustained efficacy after a single intravitreal injection. ADVM-22 remains on partial clinical hold for dosing patients in the third cohort, with the highest dose of 6 x 10^12 vg/eye, but the company currently does not plan to dose at this level. ADVM-22 uses a proprietary vector capsid that carries an aflibercept coding sequence under the control of a proprietary expression cassette and is administered as a single intravitreal administration.

IncobotulinumtoxinA approved for blepharospasm in adults
IncobotulinumtoxinA (Xeomin, Merz) has been approved by the U.S. FDA as a first-line treatment of blepharospasm in adult patients. The approval is based on data from a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial in 61 treatment-naïve patients. The 50-unit treatment group showed statistically significant improvement compared with placebo.

Research briefs
  • Providers spend more time using an electronic health record (EHR) for an office visit and generate longer notes, according to Isaac Goldstein, BA, and fellow researchers, in their single-cohort study on how documentation behaviors have changed 10 years after EHR adoption. A total of 685,361 office visits among 70 ophthalmology providers were analyzed. The mean EHR time per office visit in 2006 was 4.2 minutes, which increased to 6.4 minutes in 2016. The median note length was 1,530 characters in 2006 compared with 3,838 characters in 2016. Median chart closure time was 2.8 hours in 2006, which lowered to 2.3 hours in 2016. A redesign of EHRs and new documentation regulations may help address these issues, the researchers concluded. The study appears in Ophthalmology.
  • Timolol, latanoprost, and travoprost alone or medications that contain timolol as an additional active substance have a good relative IOP-lowering effect after uncomplicated cataract surgery, reported J. L. Holm and coresearchers. Their systematic review analyzed the literature regarding prophylactic treatment of IOP elevation after cataract surgery. They found 23 randomized controlled trials and one nonrandomized controlled study with a total of 45 treatment arms and 14 different active substances in their qualitative synthesis. Nine trials were graded as high quality, 12 as moderate quality, and three as low quality. The primary outcomes for the review were absolute and relative pressure-lowering effect of the drugs after 3 to 8 hours and 1 day postop. The trials showed a relative effect from 18.6% to 29.6% at 3 to 8 hours and 9.8% to 23.6% at day 1. The study is published in Acta Ophthalmologica.
  • Selective laser capsulotomy using a new proprietary trypan blue formulation was safe and effective in cataract surgery, reported Pavel Stodulka, MD, and coresearchers. They focused on anterior capsulotomy creation with the CAPSULaser device (Excel-Lens) against those of manual capsulotomies. Patients were divided into cohorts based on age and cataract grade and randomly allocated for laser capsulotomy or continuous curvilinear capsulorhexis, and the anterior capsule was stained with microfiltered trypan blue 0.4%. The anterior capsulotomy was created with the laser device focused on the anterior capsule via a custom patient interface lens. There were no intraop complications. In the laser group, all capsulotomies were free-floating, with no tags or tears. The mean capsulotomy diameter was 5.03 mm overall. All capsulotomies in the laser group were within 0.1 mm of the target. Circularity accuracy was greater than 99%, and the mean centration of the capsulotomy in relation to the IOL was 0.1 mm. All parameters were statistically significant (P<.01). The study appears in the Journal of Cataract & Refractive Surgery.

This issue of EyeWorld Weekly was edited by Stacy Jablonski and Vanessa Caceres.

EyeWorld Weekly (ISSN 1089-0319), a digital publication of the American Society of Cataract and Refractive Surgery (ASCRS), 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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