EyeWorld Weekly Update, December 16, 2016

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December 16, 2016
Volume 21 , Number 47

Fovista fails two pivotal Phase 3 AMD trials

Fovista (pegpleranib, Ophthotech, New York) did not achieve its primary endpoint of mean change in visual acuity at 12 months when used with ranibizumab for the treatment of age-related macular degeneration, Ophthotech announced. The two clinical trials (OPH1002 and OPH1003) were international, multicenter, randomized, double-masked, controlled Phase 3 studies evaluating the safety and efficacy of 1.5 mg of Fovista administered in combination with ranibizumab (Fovista combination therapy) compared to ranibizumab monotherapy. In each of these trials, patients were randomized to one of two approximately equal sized treatment groups. The two Phase 3 trials enrolled an aggregate of 1,248 patients with wet AMD. The results from the databases of the two trials were unmasked and analyzed concurrently. The combined analysis from the two trials (OPH1002 and OPH1003) showed that patients receiving Fovista combination therapy gained a mean of 10.24 letters at 12 months, compared to a mean gain of 10.01 letters for patients receiving ranibizumab monotherapy, a difference of 0.23 ETDRS letters. In OPH1002 (619 treated patients), subjects receiving Fovista combination therapy gained a mean of 10.74 letters at 12 months, compared to a mean gain of 9.82 letters in patients receiving ranibizumab monotherapy ( p=0.44). In OPH1003 (626 treated patients), subjects receiving Fovista combination therapy gained a mean of 9.91 letters at 12 months, compared to a mean gain of 10.36 letters in patients receiving ranibizumab monotherapy ( p=0.71).

Allegro completes enrollmentin second DEL MAR study

The second stage of the DEL MAR Phase 2b study has completed enrollment, according to Allegro Ophthalmics (San Juan Capistrano, California). DEL MAR Stage 2 is a double-masked, placebo-controlled, randomized, multicenter, 5-month study designed to evaluate the safety and efficacy of intravitreal injections of Luminate 0.5 mg or 1.0 mg in combination with bevacizumab 1.25 mg and as an adjunctive treatment with a single treatment of bevacizumab in patients with diabetic macular edema. Luminate is a first-in-class integrin peptide therapy. Top-line data on the 75 patients is expected some time in the first half of 2017.

ROP screening moving toward telemedicine

Researchers at the University of Michigan found only 56% of medical directors at nearly 400 hospital neonatal intensive care units (NICUs) think there are enough ophthalmologists who can screen and/or treat retinopathy of prematurity (ROP) in their local area. About 28% of those surveyed said their NICU did not provide ROP care, with the most common reason being a lack of ophthalmologists. As a result, those facilities had to transfer babies needing treatment to another hospital. The U Michigan researchers said "there's an opportunity to build programs that permit remote screening of babies and identifying those who can stay in their communities," based on their own experiences with infants transferred into their facility. The key to increased telemedicine will be education, the researchers said, as many of the NICUs surveyed were unaware of a 2014 National Eye Institute study noting telemedicine was as effective a strategy as regular examinations by ophthalmologists onsite.

Estrogen may increase risk of vision loss in rare genetic disorder

Girls with a neurofibromatosis type 1 (NF1) caused by mutations in the Nf1 gene are much more likely to lose their vision than boys with mutations in the same gene. Researchers at Washington University School of Medicine in St. Louis think female sex hormones activate immune cells that damage the nerves necessary for vision. University researchers said findings from their mouse study suggest that blocking or suppressing the activation of specific immune cells in the brain could save the eyesight of the 20% of children with NF1-associated brain tumors that involve the optic pathway.

Glaucoma drug may be useful treatment for Alzheimer's

Researchers at the University College London Institute of Ophthalmology published study results suggesting brimonidine can reduce the formation of amyloid proteins in the retina. These same proteins are present in the retinas of people with Alzheimer's. Francesca Cordeiro, lead investigator, said brimonidine reduces neurodegeneration of retina cells by cutting the levels of beta amyloid in the eye; the drug stimulates the production of an alternative non-toxic protein that does not kill nerve cells.

RESEARCH BRIEFS

  • The causative organisms responsible for acute-onset endophthalmitis after clear corneal cataract surgery over the past two decades have not changed, but a number of isolates are now resistant to cephalosporins and fluoroquinolones, according to a new study. N.A. Yannuzzi and colleagues retrospectively reviewed records for 63 eyes (63 patients) that presented to a tertiary referral center between 2006 and 2015 with culture-positive endophthalmitis occurring within 6 weeks of clear corneal cataract surgery. The mean time between surgery and diagnosis of endophthalmitis was 8 days. The initial treatment included intravitreal vancomycin and ceftazidime in 59 of 63 (94%) eyes and intravitreal vancomycin and amikacin in four of 63 (6%) eyes. Intravitreal dexamethasone was used in 50 of 63 (79%) eyes. A vitreous tap and injection with antibiotics was performed as the initial treatment in 57 of 63 (90%) eyes and pars plana vitrectomy in six of 63 (10%) eyes. Coagulase-negative Staphylococcus was isolated in 39 of 63 (62%) eyes, Staphylococcus aureus in seven of 63 (11%) eyes, and Streptococcus species in seven of 63 (11%) eyes. A VA of ≥20/40 was achieved in 24 of 63 (38%) eyes. None of the gram-positive isolates were vancomycin-resistant. Twenty-four of 49 isolates (49%) were sensitive to cephalothin, cefazolin, and cefuroxime. Sensitivity to fluoroquinolones included 22/52 (42%) to levofloxacin, 20/54 (37%) to ciprofloxacin, 16/47 (34%) to moxifloxacin, and 3/13 (23%) to gatifloxacin. The study is published in the American Journal of Ophthalmology.
  • Eighteen-month results indicate transepithelial PRK is both safe and efficacious in the treatment of myopia and astigmatism, according to Soheil Adib-Moghaddam, MD, and colleagues. In their prospective, interventional case series, one-step transepithelial PRK was performed with an aberration-free aspheric optimized profile and the Amaris 500 laser (Schwind eye-tech-solutions, Kleinostheim, Germany) on 146 eyes (74 patients). At 18 months, 93.84% of eyes had an uncorrected distance visual acuity of 20/20 or better, and 97.94% of eyes were within ±0.5 D of the targeted spherical refraction. Photopic and mesopic contrast sensitivities and ocular and corneal spherical, cylindrical, and corneal coma aberrations significantly improved (all P<.001). A slight amount of trefoil aberration was induced (P<.001, ocular aberration; P<.01, corneal aberration). No eye lost more than one line of corrected distance visual acuity. No eye had a haze grade of 2+ degrees or higher throughout the follow-up. The study is published in the Journal of Cataract & Refractive Surgery.
  • A new trifocal enhanced depth of focus (EDOF) IOL provides visual improvement for far, intermediate, and near distances with a high level of visual quality and patient satisfaction, according to B. Torun Acar and colleagues. They enrolled 80 eyes (40 patients) who underwent cataract surgery with bilateral implantation of a diffractive trifocal IOL (Reviol Tri-ED, VSY Biotechnology, Amsterdam, Netherlands) designed with a combination of EDOF. There was a significant improvement in all vision parameters postoperatively. The defocus curve confirmed good visual acuity in the intermediate distance. The postoperative manifest refractive spherical equivalent ranged from -0.75 to 0.75 D. Contrast sensitivity also significantly improved postoperatively. The patient satisfaction was high. The study is published in BMC Ophthalmology.

NEW PRODUCT BRIEF

  • Bausch + Lomb (Bridgewater, New Jersey) launched the Zenlens diagnostic lenses in a new 28 lens set format. Adding to the classic Zenlens 24 lens Dx format, which features six lenses in two diameters (16 and 17 mm) and two separate designs (prolate and oblate), the new 28 lens set adds four diagnostic lenses with toric peripheral curves.

EYEWORLD WEEK Online is edited by Stacy Majewicz and Michelle Dalton.

EyeWorld Week Online (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: David F. Chang, MD, chief medical editor; Bonnie An Henderson, MD, cataract editor; Clara C. Chan, MD, cornea editor; Reay H. Brown, MD, glaucoma editor; Kerry D. Solomon, MD, refractive editor; and John A. Vukich, MD, international editor

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