EW Weekly, December 13, 2019

2019-12-13

Enrollment for ocular GVHD treatment Phase 3 trial 50% complete
Enrollment for a Phase 3 clinical trial for OCU300 (brimonidine 0.18% nanoemulsion, Ocugen) to treat ocular graft-versus-host disease (GVHD) is 50% complete, according to a company announcement. The double-masked, placebo-controlled, 84-day trial will include 60 patients randomized 2:1 to receive OCU300 or a placebo. The trial will focus on the safety and efficacy of the agent to treat ocular redness and discomfort in patients with ocular GVHD. The endpoints are ocular discomfort based on a 10-point visual analog scale and ocular redness based on a 100-point validated bulbar redness score. Topline results are expected in the second half of 2020. The company has an Orphan Drug Designation for OCU300, and this is the first Phase 3 clinical trial for a treatment for this disease, according to Ocugen.

Natural history study initiated for RP caused by EYS gene mutations
The Foundation Fighting Blindness has initiated a natural history study for people with retinitis pigmentosa caused by mutations in the gene EYS, according to a foundation press release. The study is called the Rate of Progression in EYS Related Retinal Degeneration, and study goals include estimating the rate of disease progression and evaluating the usefulness of various outcome measures for future clinical trials. The study’s three participant cohorts include 1) an estimated 70 participants with a visual acuity of 20/80 or better and visual field diameter of 10 degrees or more, 2) an estimated 20 participants with a visual acuity between 20/100 and 20/400 or with a visual acuity of 20/80 or better and a visual field diameter of less than 10 degrees, and 3) an estimated 10 participants with a visual acuity of 20/500 or worse. Patients will make four annual visits for exams and vision testing. Visual fields, retinal sensitivity, and size of the ellipsoid zone will be among the aspects of vision and retinal health that will be measured.

Regulatory approval for ILUVIEN given in Benelux countries
The Benelux countries of Belgium, The Netherlands, and Luxembourg have granted marketing authorization for ILUVIEN (Alimera Sciences) to prevent relapse of recurrent noninfectious uveitis that affects the posterior segment, according to a company announcement. Alimera’s French distribution partner, Horus Pharmaceuticals, will help the company achieve reimbursement in all three countries and help oversee distribution throughout those countries for the new indication.

ASCRS and AAO announce Ophthovation Conference and leadership
ASCRS and AAO unveiled the name of their joint venture, a twice-yearly business conference that was announced earlier this year, and the leadership that will be involved. The inaugural 2020 Ophthovation Conference will be held May 14, 2020, ahead of the ASCRS Annual Meeting in Boston, chaired by Eric Donnenfeld, MD, Edward Holland, MD, and Tom Samuelson, MD, with program chair Gil Kliman, MD. The second meeting will take place Nov. 12, 2020, ahead of AAO’s annual meeting in Las Vegas. These conferences are designed to advance innovation in ophthalmology for entrepreneurs, executives, investors, and ophthalmologists. “Ophthovation is truly a novel opportunity to cultivate and accelerate a variety of ophthalmic businesses leveraging the vast resources of AAO and ASCRS,” Dr. Kliman said in an ASCRS press release. “Using new formats and enhanced networking opportunities, it will bring together large and small companies, institutional investors, and entrepreneurial ophthalmologists and researchers. This unique cross-pollination of innovative talent, clinical acumen, and financial expertise will expedite delivery of new treatments to patients around the world.”

Research briefs
  • When exposed to increased ground-level ozone concentration, there was more ocular discomfort and lowered tear secretion in patients with dry eye disease who were part of a prospective observational study, according to Yewon Kim, MD, and coresearchers. Their study included patients with dry eye treated with 0.05% cyclosporine or 3% diquafosol and who were examined twice at 2-month time periods. Those with a short tear film breakup time (TBUT) and positive ocular surface staining were assigned to the study groups. In addition to measurements such as Ocular Surface Disease Index (OSDI) score, tear secretion, TBUT, and cornea fluorescein staining, ground-level ozone concentration for a week before the ocular exams also was used as the measure of ozone exposure. Researchers tracked changes in dry eye parameters according to changes in ozone concentration. Among the 33 patients in the study, ozone concentrations were significantly associated with increased OSDI scores and lowered tear secretion. The cyclosporine group showed more changes in the OSDI score and tear secretion with changes in the ozone concentration. The study is published in Cornea.
  • More exposure to particulate matter with an aerodynamic diameter of < 2.5 micrometers (PM2.5) was associated with self-reported glaucoma and adverse structural characteristics of the disease, according to Sharon Y.L. Chua, PhD, and coresearchers. They used questionnaire data, ophthalmic measures, and ambient residential area air quality data for 111,370 U.K. Biobank participants. Ocular measures included self-reported glaucoma, IOP, and average thickness of the macular ganglion cell-inner plexiform layer across nine Early Treatment Diabetic Retinopathy Study retinal subfields. Those with higher PM2.5 concentration more often reported a glaucoma diagnosis and a thinner ganglion cell-inner plexiform layer. Researchers found a dose-response relationship between higher levels of PM2.5 and thinner ganglion cell-inner plexiform layer but not a clinically relevant relationship between PM2.5 concentration and IOP. The latter may suggest a relationship that occurs through a non-pressure-dependent mechanism, such as neurotoxic and/or vascular effects, the researchers concluded. The research appears in Investigative Ophthalmology and Visual Science.
  • After an adequate capsulorhexis, phacoemulsification in eyes with long anterior zonules can be safely done, according to Mona Khurana, MS, and coresearchers. Their retrospective interventional case series focused on 65 eyes (52 patients) with clinically proven long anterior zonules who had phaco by a single surgeon. The primary outcome measure was the incidence of capsulorhexis extension or the need for rescue intraoperatively, as well as the rate of intraoperative complications. All cases had successful completion of an adequately sized capsulorhexis. The only intraoperative complication was a posterior capsular rupture in one eye. The mean postop corrected distance visual acuity at a mean of 26.8 days was 0.05 logMAR. The percentage of eyes within 0.5 D of the target refraction was 77% and 94%, respectively. The research is published in the Journal of Cataract & Refractive Surgery.
  • An increased risk of cardiac valve disorders and benign prostate hyperplasia were found among patients with pseudoexfoliation syndrome, in addition to previously established risks such as respiratory, cardiovascular, and urogenital comorbidities, reported Elizabeth Scharfenberg, MD, and coresearchers. An increased risk for renal and psychiatric comorbidities were nominally significant. There was no substantially higher frequency for hernias, aneurysms, aortic dissection, or varicose veins. The increased risks may be manifestations of the underlying systemic elastic fibrillopathy in these patients, the researchers reported. The study is published in the Graefe’s Archive for Clinical and Experimental Ophthalmology.
Product news
  • The FDA approved the Chemistry, Manufacturing and Controls Prior-Approval Supplement for the EYLEA (aflibercept, Regeneron Pharmaceuticals) Injection prefilled syringe. The syringe is 2 mg and is a single dose.
  • Bausch + Lomb announced the launch of the enVista toric MX60ET hydrophobic acrylic IOL with StableFlex technology. It has a glistening-free optic and a range of cylinder powers as low as 1.25 D.

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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