EyeWorld Weekly Update, September 28, 2018

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September 28, 2018
Volume 24 , Number 36

Novartis files for ranibizumab indication for ROP

Novartis (Basel, Switzerland) announced the results of a Phase 3 study with ranibizumab (Lucentis) compared with laser surgery in premature infants with retinopathy of prematurity (ROP). The RAINBOW study marginally missed statistical significance for its primary endpoint, but the difference in treatment success between ranibizumab 0.2 mg and 0.1 mg groups compared with laser surgery (80%, 75%, and 66.2%, respectively) were still considered clinically relevant by the company. "Based on the favorable benefit-risk profile, Novartis plans to file for a new indication for Lucentis for the treatment of ROP to support this rare but important patient population," according to a company press release.

SiteOne Therapeutics awarded NIH grant to develop ocular pain treatments

SiteOne Therapeutics (Bozeman, Montana) has been awarded a $1.4 million, 2-year, Phase 2 SBIR grant from the National Eye Institute (NEI) to initiate Investigational New Drug (IND)-enabling studies for the company's Ocular Nav1.7 program for pain associated with ocular surgery, injury, and disease. The company previously received two other grants from the NEI/National Institutes of Health (NIH). Nav1.7 is a voltage-gated sodium channel that plays a role in the generation and conduction of action potentials in sensory neurons, according to a company press release. SiteOne has discovered a chemical series of highly selective inhibitors of human Nav1.7. SiteOne's leading Nav1.7 program, an intravenous injection to treat postop acute pain, is expected to enter clinical testing in 2019, according to a company press release. A subcutaneous program will move into preclinical evaluation later this year, and the company anticipates filing an IND for its ocular program in 2020.

First patients enrolled in trails for DME, macular telangiectasia

Oxurion NV (Leuven, Belgium) has enrolled the first patients in two separate trials: one for diabetic macular edema (DME) and the second for macular telangiectasia type 1. The Phase 1 DME trial is an open-label, multicenter, dose-escalation study to evaluate the safety of a single injection of THR-687. THR-687 is a pan-RGD integrin antagonist. The study will focus on the safety of a single intravitreal injection of escalating dose levels of THR-687 and will enroll a maximum of 18 patients. The second trial is a Phase 2, open-label multicenter study to evaluate the efficacy and safety of intravitreal THR-317, an anti-placental growth factor antibody. That trial plans to enroll 10 patients with macular edema caused by macular telangiectasia type 1.

Study: Ocular manifestations found in all children with Zika virus

Eye abnormalities were found in pediatric patients enrolled in a study that focused on ophthalmic manifestations of confirmed or suspected antenatal Zika virus exposure, according to Irena Tsui and coresearchers. Infants with antenatal Zika virus were referred for evaluation during the 2015/2016 Rio de Janeiro, Brazil outbreak. Among 224 infants, 189 had reverse transcriptase polymerase chain reaction (RT-PCR) performed. Of the 189 patients, 156 had positive RT-PCR results in their blood, urine, and/or placenta. Ninety of the 224 infants had central nervous system abnormalities. About 25% of the infants had eye abnormalities, of which optic nerve and retina abnormalities were the most common. The group with suspected Zika infection had proportionally more eye and central nervous systemic abnormalities. Eye abnormalities consistent with Zika infection were clinically comparable in both RT-PCR-positive and unconfirmed groups. All infants born after Zika outbreaks should be universally screened for eye abnormalities, the authors concluded. The research is published in Pediatrics.

ASCRS Task Force releases preliminary CyPass withdrawal consensus statement

The American Society of Cataract and Refractive Surgery convened a CyPass Withdrawal Task Force to review the data from the COMPASS-XT study and related research, and develop an independent physician guidance document associated with the voluntary withdrawal of the CyPass Micro-Stent (Alcon, Fort Worth, Texas). This week the Task Force released its Preliminary ASCRS CyPass Withdrawal Consensus Statement. The ASCRS document follows the September 14, 2018 FDA Safety Communication Statement. Further details on the results of the 5-year follow-up study of the CyPass Micro-Stent and additional resources are available at www.alcon.com/CyPass.

2019 ASCRS Ophthalmology Hall of Fame nominations due on Monday

Nominations for the 2019 ASCRS Ophthalmology Hall of Fame are due Monday, October 1. Do you know someone who has made a significant contribution to ophthalmology? Nominate him or her today. Eligible candidates are those with 25 or more years of scholarly achievement and at least one solid, defining contribution to ophthalmology in clinical practice, research, education, invention, or humanitarian work. Chosen inductees will be recognized at the 2019 ASCRS/ASOA Annual Meeting, being held May 3-7, 2019 in San Diego. An induction ceremony will be held during the ASCRS Opening General Session on May 4. View the 2018 Hall of Fame video honoring I. Howard Fine, MD, and David Maurice, PhD, online.

Research briefs

  • Corneal regraft survival varied with indication for the first graft surgery and for Fuchs' endothelial dystrophy with type of regraft procedure performed, reported Jonathan Aboshiha and coresearchers. They compared actuarial regraft 5-year survival rates for the three main indications and types of grafts: penetrating keratoplasty (PK) and deep anterior lamellar keratoplasty for keratoconus, PK and endothelial keratoplasty (EK) for Fuchs' endothelial dystrophy, and pseudophakic bullous keratopathy (PBK). Among 9,925 regrafts analyzed during the 17-year study period, PK represented 73.2% of the cohort. The median time to first regraft for all graft types was 28 months. Survival was similar after lamellar and PK procedures for first regrafts in keratoconus and PBK. There was a higher regraft survival after PK for Fuchs' compared with EK. For Fuchs' and PBK, the permutation of graft and subsequent first regraft procedure were not associated with any survival benefit for the first regraft. The outcomes may help with decision-making to manage a failed corneal transplant, the researchers concluded. The study is published in JAMA Ophthalmology.
  • Use of a custom monofocal aspherical IOL decreased overall ocular spherical aberration, reported Jens Schrecker, MD, and coresearchers. Their prospective case series randomized cataract surgery patients receiving an individual aberration-correcting IOL (Group A, 57 eyes of 42 patients) or a standard aspheric aberration-free IOL that otherwise had an identical design (Group B, 29 eyes of 27 patients). The IOL in Group A was designed according to preop calculation of corneal spherical aberration Z(4,0). The goal was to achieve an overall postop ocular spherical aberration of close to zero. Residual ocular spherical aberration Z(4,0) was significantly lower in Group A; photopic and mesopic contrast sensitivities with and without glare were significantly higher in Group A at most spatial frequencies. There were no significant differences in monocular defocus curve and visual acuity outcomes between the groups. The study is published in the Journal of Cataract & Refractive Surgery.
  • Prolonged reading can worsen dry eye, according to a prospective, observational clinical study. Sezen Karakus, MD, and coresearchers analyzed 177 patients with dry eye and 34 normal controls, all age 50 and older. After evaluating symptoms with the Ocular Surface Disease Index (OSDI) questionnaire, researchers performed a variety of dry eye tests, including automated noninvasive tear breakup time and Schirmer's testing without anesthesia. Study participants read a 30-minute validated passage silently, after which the dry eye tests were performed again. With the exception of surface asymmetry index, all parameters worsened after the reading task. Worsening was statistically significant for corneal and conjunctival staining in the dry eye group (P<0.001) and for corneal staining in the control group (P<0.01). At baseline, OSDI scores correlated only with corneal and conjunctival scores but at post-reading, baseline OSDI scores correlated with tear breakup time and corneal and conjunctiva staining. Corneal staining worsening correlated directly with baseline conjunctival staining and surface regularity index. Quantifying dry eye after visually straining activities may help better understand patient symptomatology, the researchers concluded. The study is published in Ophthalmology.

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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