EyeWorld Weekly Update, May 26, 2017

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May 26, 2017
Volume 22 , Number 20

FDA approves tocilizumab for giant cell arteritis

The U.S. Food and Drug Administration (FDA) approved tocilizumab (Actemra, Genentech, South San Francisco) subcutaneous injection to treat giant cell arteritis. Actemra is the first FDA-approved agent to treat adult patients with giant cell arteritis. Approval was based on positive outcomes from the international, randomized, placebo-controlled Phase 3 GiACTA study, which showed that when combined with a 6-month steroid regimen, Actemra more effectively sustained remission through 52 weeks, according to a Genentech press release. Fifty-six percent of people in the Actemra group and 53.1% in the biweekly group sustained remission. Giant cell arteritis, if left untreated, can lead to blindness, aortic aneurysm, or stroke. Actemra is a humanized interleukin-6 receptor antagonist that is approved to treat adults with moderate to severe active rheumatoid arthritis who did not find enough relief with the use of a disease-modifying antirheumatic drug. The agent is also used as an IV formulation for active polyarticular juvenile idiopathic arthritis or systemic juvenile idiopathic arthritis in patients 2 years of age or older.

Some Ebola survivors found to have unique retinal lesion

More than 14% of Ebola survivors were found to have a unique retinal lesion that followed the anatomic distribution of the optic nerve, reported Paul Steptoe, and co-investigators in their case-control study that focused on ocular signs in Ebola virus disease survivors in Freetown, Sierra Leone. Eighty-two survivors with ocular symptoms and 105 controls had an ophthalmic examination, including widefield retinal imaging. A little more than 7% of Ebola survivors had unilateral white cataracts compared with none seen in the controls. The aqueous humor from two of the Ebola survivors with cataract but no anterior chamber inflammation was polymerase chain reaction-negative for Zaire Ebola virus, allowing for cataract surgery. The retinal lesion was found in 14.6% of survivors but no controls, suggesting neuronal transmission as a route of ocular entry, the investigators concluded. The report appears in Emerging Infectious Diseases, published by the Centers for Disease Control and Prevention.

Phase 3 results released for combination glaucoma treatment

In the Mercury 2 trial, topline efficacy results were achieved with netarsudil/latanoprost ophthalmic solution (Roclatan, Aerie Pharmaceuticals, Irvine, California), according to a company press release. The product had statistical superiority over each of its components, netarsudil ophthalmic solution 0.02% (Rhopressa, Aerie Pharmaceuticals) and latanoprost. Roclatan lowered IOP by 1 to 3 mm Hg greater than monotherapy with latanoprost or Rhopressa throughout the study. The study included patients with baseline IOPs from above 20 mm Hg to 36 mm Hg. In 56% of patients, Roclatan reduced mean diurnal IOPs to 16 mm Hg or lower, which was significantly higher than the two comparator arms. Hyperemia was the most common adverse event (in 55% of patients) and was scored as mild for the majority of patients. There were no drug-related serious or systemic adverse events in any treatment group. The company expects to submit the Roclatan New Drug Application to the FDA in the first half of 2018.

Postmarket safety events affect more than 30% of new FDA-approved meds

Of 222 new therapeutics approved by the FDA between 2001 and 2010, 32% were affected by a postmarket safety event, according to Nicholas Downing, MD, and co-investigators. The agents with the most postmarket safety events were biologics treatments for psychiatric disease, those receiving accelerated approval, and those with near-regulatory deadline approval. Investigators conducted a cohort study of all new therapeutics approved by the FDA between 2001 and 2010 and that were followed up through February of this year. The research highlights the need for continuous safety monitoring of new therapeutics throughout their life cycle, the investigators concluded. The research appears in JAMA.

RESEARCH BRIEFS

  • Although evidence is not strong enough to systemically recommend omega-3 and omega-6 fatty acid as a standalone treatment for dry eye disease, Ignacio Molina-Leyva, and co-investigators did observe a discrete improvement in tear function parameters during their review of randomized clinical trials with omega-3 and omega-6. The trials that they studied included 2,591 patients in 15 independent studies, all published between 2005 and 2015. Patients in the study were using supplements with different proportions of omega-3 and omega-6. Subjective improvement was measured with the Ocular Surface Disease Index test and the Dry Eye Severity Score. Seven of the studies had results in favor of omega-3 or omega-6 fatty acids. Tear break-up time greatly increased in nine studies, and Schirmer test results improved in four studies. Omega-3 and omega-6 fatty acid supplementation could be an alternative to topical treatment in dry eye syndrome secondary to specific pathologies, the authors concluded. The research is published in Acta Ophthalmologica.
  • Rapid and good visual rehabilitation can be achieved in Descemet's stripping endothelial keratoplasty with the use of imported donor corneas, according to Kaevalin Lekhanont and co-investigators. They conducted their study because of the lack of development of local donor tissue acquisition in several parts of the world. The retrospective, non-comparative series examined outcomes from 102 consecutive DSAEK procedures. Main outcome measures were postoperative best corrected visual acuity (BCVA), endothelial cell density, and complications. The mean follow-up was 65.3 months. Ninety-one percent of eyes had improved vision postop. In three eyes, the BCVA was unchanged because of a preexisting macular scar and advanced glaucoma. All eyes with improved BCVA had their best corrected vision in the first year. The mean endothelial cell density loss was 36.2%, 39.1%, 42.8%, 49.7%, and 54.7% at 6 months and 1, 2, 3, and 5 years after surgery, respectively. Graft detachment/dislocation was the most common complication (10.78%). The study appears in BMC Ophthalmology.
  • A cross-sectional study of ocular pain in patients with dry eye disease found most patients with dry eye have some degree of ocular pain, and it correlates moderately with the Ocular Surface Disease Index, according to Vannarut Satitpitakul and co-investigators. The 84 patients in the study were asked to score their ocular pain on a 10-point scale, 10 indicating the worst pain. All patients had a detailed ocular exam and assessment and completed an Ocular Surface Disease Index (OSDI) questionnaire. The mean OSDI score was 46.6; at least some pain (score >1) was reported by 88.1% of patients. Pain levels significantly correlated with the OSDI score. The severity of ocular pain also had a significant association with antidepressant agent use. However, it was not associated with tear break-up time, corneal fluorescein staining, or ocular medications. The research appears in the American Journal of Ophthalmology.
  • Femtosecond laser-assisted cataract surgery for hard nuclear cataracts conserved phacoemulsification power and helped reduce corneal endothelial damage when compared with conventional phaco, reported Xinyi Chen, MD, and co-investigators. It also led to faster visual rehabilitation. Their prospective consecutive cohort study assigned 95 cataract patients with a grade 4 or 5 hard nuclei to one of the two study groups. Endothelial cell density (ECD), central corneal thickness, and corrected distance visual acuities (CDVA) were compared preoperatively and at various points postoperatively. The effective phaco time, absolute phaco time, and mean ultrasound power were lower in the femtosecond group (P<.001, P=.001, and P<.001, respectively). The ECD in the conventional group was lower; changes in endothelial cell loss were different between the two groups throughout the follow-up period. The CDVA was stable by 1 month postop in the femtosecond group and by 3 months in the conventional group. The study appears 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; Reay Brown, MD, glaucoma editor; and Vance Thompson, MD, refractive editor.

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