EW Weekly, November 9, 2018

November 9, 2018
Volume 24 , Number 41

Phase 3 clinical trial begins for SkQ1 compound for moderate to severe dry eye

A Phase 3 clinical trial has begun with the SkQ1 compound (Visomitin, Miotech, Luxembourg City, Luxembourg) in patients with moderate to severe dry eye disease. SkQ1 was created to reduce oxidative stress within the mitochondria. The trial is a multicenter, randomized, double-blind, placebo-controlled study with three treatment arms that will include two different concentrations of SkQ1 and a placebo given twice a day. Results are expected by the second quarter of 2019. A Phase 2 trial of Visomitin with 90 patients showed statistically significant superiority over placebo for several endpoints, according to a company press release.

Phase 3 study for retinal vein occlusion treatment does not meet primary endpoint

The primary endpoint was not met in the Phase 3 SAPPHIRE clinical trial, which focused on the superiority of Xipere (formerly suprachoroidal CLS-TA, Clearside Biomedical, Alpharetta, Georgia) used in combination with intravitreal aflibercept (Eylea, Regeneron Pharmaceuticals, Tarrytown, New York) to treat retinal vein occlusion. The SAPPHIRE trial included 460 patients with treatment naïve retinal vein occlusion; its primary endpoint was the proportion of patients in the combination treatment arm compared to the intravitreal aflibercept-alone control arm with improvements in best corrected visual acuity from baseline and at least 15 letters on the Early Treatment Diabetic Retinopathy Study. About 50% of patients in the SAPPHIRE trial in both arms had at least a 15-letter improvement, but there was no additional benefit in receiving Xipere along with aflibercept, according to a Clearside press release. The company plans to discontinue clinical development of the agent with combination therapy for retinal vein occlusion.

Further results from Phase 2 study for teprotumumab for thyroid eye disease

More detailed results from a Phase 2 clinical trial for teprotumumab (Horizon Pharma, Dublin, Ireland) were announced in late October. Teprotumumab is for moderate to severe active thyroid eye disease. The Phase 2 trial showed that 69.2% of those with diplopia who showed improvement of at least one grade at week 24 maintained these improvements at week 72 (48 weeks following treatment period), according to a Horizon press release. "The Phase 3 confirmatory trial and extension studies will evaluate diplopia in people with moderate to severe thyroid eye disease," according to the press release. The company's Phase 2 study focused on the efficacy and safety of teprotumumab and had a primary endpoint of response in the study eye, defined as a decrease in the clinical activity score of 2 points or greater and a reduction of proptosis of 2 mm or greater at week 24. Sixty-nine percent of patients receiving the agent and 20% receiving placebo were responders at week 24. Teprotumumab is a fully human monoclonal antibody and a targeted inhibitor of the insulin-like growth factor 1 receptor. The agent has Breakthrough Therapy, Orphan Drug, and Fast Track Designations from the U.S. Food and Drug Administration.

Topline results announced in Phase 2 trial for dry eye treatment

Positive topline results were announced from the Phase 2 clinical trial of NOV03 (100% perfluorohexyloctane, Novaliq, Heidelberg, Germany) to treat dry eye disease. NOV03 is a preservative-free ophthalmic solution and is the first drug created to treat evaporative dry eye disease with meibomian gland dysfunction, according to a company press release. The multicenter, randomized, double-masked, saline-controlled Phase 2 trial included 336 patients at 10 clinical sites around the U.S. The trial evaluated the effects of NOV03 on dry eye signs and symptoms at two different dosing regimens, with primary efficacy evaluated at 8 weeks. Improvement of total corneal fluorescein staining compared with controls took place at 8 weeks, with high statistical significance for both dosings at four times daily and twice daily. The effect began as early as 2 weeks after treatment began. Those treated with NOV03 also had better control of symptoms.

Submit complicated and challenging cases today

The ASCRS Cataract Clinical Committee is seeking video cases for the Challenging Cases in Cataract Surgery Video Symposium during the 2019 ASCRS/ASOA Annual Meeting in San Diego. This symposium will take place on May 6, 2019 from 8-9:30 a.m. Speakers will have the opportunity to present unusual and challenging video cases involving any aspect of phaco, femtosecond laser-assisted cataract surgery, and/or IOLs from their practice. Submission criteria are:

  • One submission per person.
  • *New for 2019: The submitter should be the senior author/producer of the video.
  • Videos should be no longer than 5 minutes.
  • Be certain the video is created as an MPEG or Windows Media file (.wmv). No exceptions will be made.
  • A maximum of two PowerPoint slides should be included (one containing title and financial interest, the second with a brief case history).
  • If the video will not include narration, please note this in the PowerPoint slide.
If your case is selected, you will have 10 minutes to describe the clinical aspects of the case. Please allow 8 minutes for the presentation with 2 minutes for panel discussion from the ASCRS Cataract Clinical Committee. The selection criteria will be based upon clinical and educational merit. If you plan to attend the meeting and would like to submit a video case for this special session, please contact Jennifer Carstens for an invitation to upload a copy of your video to the ASCRS Dropbox account. All videos must be received via Dropbox by November 19.

Research briefs

  • Donor diabetes, a lower screening endothelial cell density, a pseudophakic/aphakic corneal edema (PACE) diagnosis, and operative complications were associated with lower endothelial cell density at 3 years after Descemet's stripping automated endothelial keratoplasty (DSAEK) and may be factors associated with long-term graft outcomes, reported Jonathan Lass, MD, and coresearchers from the Cornea Preservation Time Study. The association of donor diabetes and PACE in recipients with lower 3-year endothelial cell density is worthy of further study, the researchers said. The study included participants who were having DSAEK for Fuchs' dystrophy or pseudophakic/aphakic corneal edema. The study included 40 U.S. clinical sites from the multicenter, double-masked, randomized clinical trial. Study participants randomly received a donor cornea with a preservation time of 0 to 7 days or 8 to 14 days. A total of 1,090 participants were included with 1,330 affected eyes. The previously mentioned factors all were associated with a lower endothelial cell density at 3 years. The results appear in JAMA Ophthalmology.
  • Corneal incisions that were 2.20 mm wide were more prone to trauma compared with 2.85 mm incisions during routine cataract surgery, according to a prospective case series from Sunny Li and fellow researchers. There were 50 eyes in both groups in which patients were randomized to receive 2.20 mm or 2.85 mm uniplanar clear corneal incisions. Researchers used optical coherence tomography measurements of incision thickness, length, width, gaping, and several other measurements at baseline and 1, 7, 30, and 90 days postop. With the 2.20 mm incision, the Descemet's membrane detachment rate was greater than 50% (P=.01); those with Descemet's membrane detachments also had increased endothelial cell gaping, slower visual recovery, and increased corneal thickness at the incision site. The 2.20 mm group had greater polymegathism even though there was no difference in mean phaco energy between the groups. At 90 days, the 2.20 mm group had a lower mean endothelial cell density than the 2.85 mm group. There was no significant difference in final visual acuity, gaping, and angles between the groups. 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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