EW Weekly, June 21, 2019

First patient dosed in Phase 2 trial for ST266 to treat persistent corneal epithelial defects
The first patient has been dosed in a Phase 2 open-label, multicenter clinical trial focused on topical ocular delivery of ST266 (Noveome Biotherapeutics) for the treatment of persistent corneal epithelial defects, according to a company press release. The trial’s primary endpoint is complete healing as determined by fluorescein dye after 28 days of therapy. Each patient in the trial will receive four doses of ST266 daily over the 28-day time period. Topline study results are expected later this year. ST266 is a cell-free "platform" biologic that contains hundreds of proteins and other factors involved in cellular healing, brain and nerve protection, and the modulation of inflammation.

First subject enrolled in trial for safety, efficacy of TearCare for dry eye
Sight Sciences has enrolled the first subject in OLYMPIA, a U.S.-based pivotal trial to further analyze the safety and efficacy of TearCare in patients with dry eye disease, the company reported. TearCare is a wearable, personalized, open-eye technology delivering regulated, localized heat to the eyelids to help clear the meibomian glands and restore the production of healthy clear meibum. OLYMPIA is a prospective, multicenter, randomized, controlled study that will include 138 subjects across 10 centers. The trial will evaluate TearCare versus LipiFlow (Johnson & Johnson Vision) to treat the signs and symptoms of dry eye.

Topline results announced from Phase 1/2a trial of RBM-007 for wet AMD
Topline results have been announced from the SUSHI study, a Phase 1/2a single ascending dose clinical study of RBM-007, an anti-fibroblast growth factor 2 aptamer, in subjects with wet age-related macular degeneration (AMD). In the study, the primary endpoint of safety and tolerability was achieved, and there were demonstrated efficacy trends in favor of RBM-007. The SUSHI study is an open-label, dose-escalation study in nine patients who had previously received three or more anti-vascular endothelial growth factor (VEGF) treatments without resolution of wet AMD. Study eyes received a single intravitreal injection of RBM-007 in three sequential dose cohorts: 0.2 mg, 1.0 mg, and 2.0 mg, respectively. All subjects had wet AMD that was poorly responsive to intravitreal anti-VEGF therapy. A single dose of RBM demonstrated no dose-limiting toxicities and no systemic or ocular serious adverse events through the 56-day exit visit, excluding one uncompleted case in the last cohort. In Cohort 3, one subject had anterior inflammation that resolved after a day of prednisolone treatment. Company leaders are planning the next multidose Phase 2 trial, with enrollment expected to begin in the third quarter of this year.

Itchiness from ocular allergy controlled with antihistamine-releasing contact lens
A contact lens that releases the antihistamine ketotifen was effective in controlling ocular itch due to allergy, reported Brian Pall, OD, and coresearchers, in a study recently published in Cornea. The contact-lens based drug delivery system was tested in two parallel, conjunctival challenge-based trials. Both trials used the same multicenter, randomized, placebo-controlled protocol. The test lenses used were etafilcon A with 0.019 mg of ketotifen and contact lenses with etafilcon A but no added drug. Subjects in Group 1 received a test lens in one eye and a control lens in the other eye; Group 2 participants received test lenses bilaterally; and Group 3 subjects received control lenses bilaterally. There was a total of 244 participants. Allergen challenges took place on two separate visits. The primary endpoint was ocular itching measured on a scale of 0 to 4 with half-unit steps. The mean itch scores were lower in eyes wearing the test lens compared with those that received control lenses. The mean differences in itching were statistically and clinically significant.

Don't miss the best rate for the ASCRS ASOA Combined Ophthalmic Symposium
Register today for the 2019 ASCRS ASOA Combined Ophthalmic Symposium , August 23–25 in Austin, Texas at the JW Marriott . The Tier One registration deadline is Monday, July 1. The ASCRS and ASOA Combined Ophthalmic Symposium provides education for an entire ophthalmic practice in one weekend and offers opportunities for integrated staff development through educational tracks for ophthalmologists, young eye surgeons, practice management staff, optometrists, and nurses and technicians. In addition, the ASCRS and ASOA Combined Ophthalmic Symposium hosts a world-class exhibit hall featuring industry exhibitors representing a variety of products and services.

Research briefs
  • In a review and meta-analysis of keratoconus natural history, younger patients and those with a Kmax of steeper than 55 D at presentation have a higher risk of keratoconus progression, reported Alex Ferdi, MBBS. The review included prospective or retrospective studies of pediatric or adult patients who reported one or more of visual acuity, refraction, and corneal curvature measures, including steep keratometry, mean keratometry, and maximum keratometry. Among 3,950 searched publication titles, 41 were included in the systematic review, and 23 were incorporated into the meta-analysis. Younger patients and patients with greater Kmax had more Kmax steepening at 12 months. A meta-analysis of Kmax found a significant increase in Kmax of 0.7 D at 12 months (P=0.003). It was predicted that patients would have 1 D greater Kmax steepening for every 5 D of greater baseline Kmax. In patients younger than 17 years and with a steeper than 55 D Kmax, closer follow-up and a lower threshold for crosslinking should be adopted, the researchers concluded. The study appears in Ophthalmology.
  • Anesthesia recovery after ophthalmic surgery at an ASC was associated primarily with the procedure and anesthesia type, according to a retrospective case series from Kyle Russell, RN. Researchers reviewed health records of adult patients having ophthalmic procedures at one ASC location from July 1, 2010, to Sept. 30, 2016. Anesthesia recovery duration also was calculated. The median recovery was 36 minutes among the 20,116 procedures. The longest recovery based on anesthesia type was for general anesthesia (79 minutes). The longest recovery based on procedure was observed for orbitotomy and strabismus procedures; cataract surgery had the shortest recovery. Prolonged recovery was associated with the female sex, obstructive sleep apnea, greater disease burden, longer procedures, and intraop fentanyl administration. There were more severe pain episodes in patients with prolonged recovery; this same patient group received more opioid analgesics during recovery. A prolonged recovery was associated with higher rates of emergency department visits and hospitalizations in the first 48 hours postop as well as higher 30-day mortality rates. The study is published in the Journal of Cataract & Refractive Surgery.
  • Ocular pain scores were significantly associated with systemic pain scores in a cross-sectional study, reported R. Yamanishi and fellow researchers. The 41 participants in the study had ocular pain symptoms and had a Dry Eye-Related Quality of Life Score (DEQS), the Short-Form McGill Pain Questionnaire (SF-MPQ), visual analog scale (VAS), and an ophthalmologic examination, including tear breakup time measurement and Schirmer 1 test. The revised Asia Dry Eye Society Dry Eye Disease diagnostic criteria were used. The mean age of participants was 57.6 years; 31 participants were women. The DEQS was significantly associated with the SF-MPQ score and the VAS. The DEQS also had a significant positive linear correlation with the SF-MPQ total and the VAS. The research is published in Ocular Surface.

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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