EyeWorld Weekly Update, July 6, 2018

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July 6, 2018
Volume 24 , Number 24

NDA resubmitted for dexamethasone insert

Ocular Therapeutix (Bedford, Massachusetts) has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Dextenza (dexamethasone insert) 0.4 mg. The resubmission addresses manufacturing deficiencies cited by the FDA in a July 2017 Complete Response Letter. "Since last July, we have worked to make substantial improvements in our manufacturing processes and quality oversight that have allowed us to reach this important milestone," said president and CEO Antony Mattessich in a press release. Mr. Mattessich said the company anticipates that Dextenza will be designated as a Class 2 (6-month) review, implying a target action date of the end of this year under the Prescription Drug User Fee Act. Dextenza has been designed as an intracanalicular insert to treat post-op ocular pain.

Phase 3 clinical trial of OCU300 begins to treat ocular graft-versus-host disease

The first of two pivotal Phase 3 trials has begun for OCU300 (Ocugen, Malvern, Pennsylvania), designed to treat ocular graft-versus-host disease, following the recent acceptance of the company's New Investigational New Drug application by the FDA, according to a company press release. OCU300 is a 0.18% ophthalmic nanoemulsion of brimonidine tartrate. The agent's pivotal clinical program consists of two randomized, double-masked, placebo-controlled studies designed to evaluate OCU300 to treat ocular discomfort and redness from ocular graft-versus-host disease. The staggered studies each will evaluate about 60 patients randomized 2:1 to receive OCU300 or a placebo. Patients will receive daily eye drops for 84 days. Primary efficacy endpoints include ocular discomfort using the visual analog scale and ocular redness using the Validated Bulbar Redness grading scale. Top-line data should be available in the second half of 2019, according to company leaders.

Katena acquires Blink Medical

Katena Products (Denville, New Jersey) has acquired Blink Medical Ltd. (Solihull, U.K.). Blink Medical focuses primarily on single-used instruments. "Single-use instruments are important to our strategy, and the addition of Blink also offers Katena the benefits of a physical presence in Europe," Katena CEO Mark J. Fletcher said in a press release.

Decrease in auto accidents associated with cataract surgery

Cataract surgery is associated with a small decrease in a patient's risk for serious auto accidents as a driver, reported Matthew B. Schlenker, MD, and fellow researchers in JAMA Ophthalmology. Their population-based study included 559,546 patients who had cataract surgery in at least one eye. The mean patient age was 76 years and 58% were women. There were 4,680 total traffic crashes during the 3.5-year baseline interval and 1,200 traffic crashes during the 1-year subsequent interval. Overall, the crash rate lowered from 2.36 per 1,000 patient years in the baseline interval to 2.14 per 1,000 patient years after surgery, which represented a 9% decrease in serious traffic accidents. There was no significant decrease in other outcomes, such as cases of traffic crashes where the patient was a passenger or pedestrian. There was a higher risk of auto accidents in younger patients, males, those with a history of crashes, those with more emergency visits, and those with frequent outpatient physician visits.

RESEARCH BRIEFS

  • An updated comprehensive system to stratify cataracts could be used to match case selection with trainee experience, reported Paul Nderitu, MB ChB, MPhil, and coresearchers. Their retrospective cohort study included patients having phacoemulsification between 2011 and 2016. Various data were extracted, including demographics, pupil size, pupil expander use, and complications. Cases with combined corneal, glaucoma, or posterior segment procedures were excluded. Patients were stratified by complexity score and surgeon grade, including consultant, junior, intermediate, senior trainee, and fellow. Among 11,468 cases, 71.5% had a complexity score. The following factors were associated with increasing complexity: small pupil, pupil expander use, iris damage during phaco, zonular dialysis, postop raised IOP, and corneal edema. Appropriate case allocation by complexity and surgeon grade resulted in no association with posterior capsule rupture and complexity score, the researchers wrote. The study appears in the Journal of Cataract & Refractive Surgery.
  • Visual impairment assessed at a distance was associated with declining cognitive function both cross-sectionally and longitudinally over time, reported D. Diane Zheng, MS, and coresearchers. Their longitudinal study of 2,350 older U.S. adults-done as part of The Salisbury Eye Evaluation Study-assessed participants at baseline and then during several rounds in subsequent years. Both visual acuity and Mini-Mental State Examination (MMSE; used to assess cognitive function) worsened over time. The average biannual visual acuity decline was 0.22 logMAR; the average biannual worsening of the MMSE score was -0.59. Worse baseline visual acuity was associated with a worse baseline MMSE score. "Worsening vision in older adults may be adversely associated with future cognitive functioning," the authors concluded. "Maintaining good vision may be an important interventional strategy for mitigating age-related cognitive declines." The research is published in JAMA Ophthalmology.
  • In a retrospective study of visual outcomes and prognostic factors in open-globe injuries, poor prognostic factors included poor visual acuity at first visit, a ruptured globe, zone III injuries, a history of penetrating keratoplasty, retinal detachment, vitreous hemorrhage, and dislocation of the crystalline lens. Led by Azusa Fujikawa, MD, their analysis of 59 eyes of 59 patients at a Japanese hospital placed 46 patients in a light perception group, while 13 were placed in a no light perception group. The most common cause of injury was work-related trauma (27 eyes; associated more with males), followed by falls (19 eyes; associated more with females). All cases of no light perception had a ruptured globe. The study appears in BMC Ophthalmology.
  • Long eyes, steep corneas, and a shallow anterior chamber depth indicated a higher risk for retained nuclear fragments in patients having cataract extraction, according to John C. Norton, BS, and coresearchers. Their retrospective case series focused on patients with a diagnosis of retained nuclear fragment in the anterior chamber after uncomplicated phaco. There were 19 patients who were identified, 13 of whom had myopia. Most had corneal edema and anterior chamber inflammation. Seventeen retained fragments were identified in the inferior angle. The mean axial length, keratometry, and anterior chamber depth values were 23.58 mm, 44.93 D, and 2.97 mm, respectively. Final corrected distance visual acuity ranged from 20/20 to 20/400. Among the group, three patients developed cystoid macular edema, and two had corneal complications after fragment removal. Prompt identification and surgical removal led to the best outcomes. The study appears in the Journal of Cataract & Refractive Surgery.
Product news
  • The Vitra 2 (Quantel Medical, Clermont-Ferrand, France) is the company's new 532 nm laser.

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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