EyeWorld Weekly Update, March 23, 2018

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March 23, 2018
Volume 24 , Number 10

Positive results for Phase 2 study with OCU310 dry eye treatment

A Phase 2 proof-of-concept trial for OCU310 (Ocugen, Malvern, Pennsylvania) had positive results. OCU310 is a nanoemulsion/suspension combination of brimonidine tartrate and loteprednol etabonate and is under development to treat dry eye disease. The randomized, multicenter, double-blind, placebo-controlled study met the primary endpoint of tolerability over 12 weeks. There were also meaningful improvements across various endpoints related to dry eye signs and symptoms compared to placebo. In the Phase 2 study, patients with dry eye disease received 0.2% brimonidine tartrate alone or with 0.2% loteprednol etabonate or placebo. They received eye drops twice a day over 12 weeks. Ocugen plans to advance to Phase 3 clinical studies in third quarter 2018, according to a company press release.

Ranibizumab 0.3 mg prefilled syringe approved for DME and diabetic retinopathy

The U.S. Food and Drug Administration (FDA) approved a 0.3 mg prefilled syringe of ranibizumab (Lucentis, Genentech, South San Francisco) to treat all forms of diabetic retinopathy. Last year, ranibizumab 0.3 mg became the first and only FDA-approved medication for all forms of diabetic retinopathy in people with or without diabetic macular edema, according to a company press release. Made of borosilicate glass and packaged in a single-use, sterile, and sealed tray, the prefilled syringe allows physicians to get rid of several preparation and administration steps with the medication, Genentech reported. The 0.3 mg prefilled syringe is expected to be available in the second quarter of this year. The Lucentis 0.5 mg prefilled syringe was approved by the FDA in October 2016 to treat wet age-related macular degeneration (AMD), macular edema following retinal vein occlusion, and myopic choroidal neovascularization.

FDA accepts New Drug Application for posterior segment uveitis treatment

A New Drug Application (NDA) for Durasert (pSivida, Watertown, Massachusetts) has been accepted by the FDA. Durasert is a sustained release 3-year treatment for posterior segment uveitis. The application will be subject to a standard review, according to pSivida. The FDA's goal date to complete the review is Nov. 5 of this year. Included in the NDA are data from two Phase 3 studies that both show that the medication successfully achieved the primary efficacy endpoint at 6 months. Safety was consistent with the safety profile of steroid treatments currently considered standard of care.

Sight recovered following use of retinal tissue engineered from stem cells

Implantation of a custom engineered patch of retinal pigment epithelium cells derived from stem cells to treat wet AMD was successfully used in two patients, according to a press release from the London Project to Cure Blindness and a report in the journal Nature Biotech. The London Project to Cure Blindness is a collaboration with London-based Moorfields Eye Hospital NHS Foundation Trust, the University College London Institute of Ophthalmology, and the National Institute for Health Research. Two patients, a woman in her early 60s and a man in his 80s, both of whom had wet AMD, had the procedure done. The research focused on whether the diseased cells at the back of the patients' affected eyes could be replenished using the stem cell-based patch. The patients received treatment at Moorfields Eye Hospital and were monitored for 12 months; vision improved from no reading ability to reading 60 to 80 words per minute with normal reading glasses. "This study represents progress in regenerative medicine and opens the door to new treatment options for people with age-related macular degeneration," said Professor Pete Coffey, University College London Institute of Ophthalmology, in the press release. "We hope this will lead to an affordable 'off-the-shelf' therapy that could be made available to NHS patients within the next 5 years."

RESEARCH BRIEFS

  • Self-reported serious sensory impairments, including serious vision impairment, increase with age but are not distributed equally among various racial and ethnic groups, reported Spencer Fuller, MPH, and coresearchers. They used the 2011 to 2015 American Community Survey from the U.S. Census Bureau, which contains data on 7.2 million individuals 45 years old or older. Among them, researchers estimated the nationwide prevalence of self-reported serious vision impairment, serious hearing impairment, and serious dual sensory impairment and characterized those associations with self-reported cognitive, self-care, and ambulatory difficulties. The estimated nationwide prevalence of self-reported serious vision impairment alone is 2.8% compared with 6% for serious hearing impairment; the prevalence of dual sensory impairment is 1.6%. A larger number of American Indians or Alaskan Natives in the study reported serious vision or hearing impairment, alone or combined, than any other race or ethnic group (P<0.001). Serious dual sensory impairment is associated with greater cognitive and functional difficulty compared with the other two categories, but serious vision impairment alone is associated with more cognitive and functional difficulties than serious hearing impairment alone. The study is published in Ophthalmology.
  • A sublingual immunotherapy tablet for birch pollen was not effective for allergic rhinitis and conjunctivitis symptoms, according to Anne Ellis, MD, and coauthors. They evaluated the treatment effect of Grastek (timothy grass pollen allergen extract tablet for sublingual use, ALK, Horsholm, Denmark) for birch pollen-induced allergic rhinitis and conjunctivitis in subjects sensitized to both grass and birch pollen. An Environmental Exposure Unit was used. The Phase 4 randomized, double-blind, placebo-controlled, parallel-group study included adults who participated in a baseline challenge where a minimum Total Nasal Symptom Score of 6/12 was required for enrollment. Subjects received Grastek or placebo once a day for 4 months. The primary endpoint was the change in Total Nasal Symptom Scores; a secondary endpoint included temporally identical changes in Total Ocular Symptom Score. There was no significant difference in Total Nasal Symptom Score after 4 months of therapy when comparing Grastek and the placebo. Changes in Total Ocular Symptom Score also were comparable. Grastek was well tolerated. The research appears in Annals of Allergy and Asthma.
  • Dry eye may be more common in patients with vitiligo with ocular involvement, reported Sevil Karaman Erdur, MD, and coauthors. They evaluated tear osmolarity and tear film parameters in patients with vitiligo, 25 of whom had periocular involvement (group 1), 30 of whom did not have periocular involvement (group 2), and 20 control patients (group 3). Mean tear osmolarity was 332 mOsm/L in group 1, 308.8 mOsm/L in group 2, and 286.3 mOsm/L in group 3. There was not a significant difference in Schirmer I test results among the groups, but tear film breakup time measurements were markedly lower in groups 1 and 2. The mean Ocular Surface Disease Index was significantly higher in groups 1 and 2 than group 3. The research appears in Cornea.
  • In a retrospective case series, negative dysphotopsia was associated with acrylic or silicone IOLs with a square- or round-edge design, reported Samuel Masket, MD, and coresearchers. Patients in the study had self-reported chronic negative dysphotopsia with corrective surgery (therapeutic group) or second eye surgery with negative dysphotopsia in the previously operated eye (preventative group). Surgical strategies used included bag-to-bag IOL exchange, reduction of posterior chamber depth, piggyback secondary IOL placement, bag-to-sulcus IOL exchange, and reverse optic capture. Among the 40 eyes in the therapeutic group, 76.6% of the causative IOLs were acrylic, and 23.4% were silicone; all were bag-fixated. There were 21 eyes in the preventative group, 11 of which were second eyes from the therapeutic group. The additional 10 did not require surgery for the symptomatic eye. Bag-to-sulcus IOL exchange and reverse optic capture were the most successful measures to manage or prevent negative dysphotopsia. The research is published in the Journal of Cataract & Refractive Surgery.

This issue of EyeWorld Weekly Update was edited by Amy Goldenberg and Vanessa Caceres.

EyeWorld Weekly Update (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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