EW Weekly, July 8, 2016

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July 8, 2016
Volume 21 , Number 24

Humira approved for uveitis

The Food and Drug Administration has approved Humira (adalimumab, AbbVie, North Chicago) for the treatment of non-infectious intermediate, posterior and panuveitis in adults, AbbVie said in a press release. Humira is the first FDA-approved non-corticosteroid therapy with these indications, AbbVie added. The FDA approval is based on results from 2 pivotal phase 3 studies, VISUAL-I and VISUAL-II. These were double-masked, randomized, and placebo-controlled clinical trials. Patients treated with Humira received an 80 mg baseline loading dose followed by 40 mg given by subcutaneous injection at week 1, followed by 40 mg every other week for up to 80 weeks. The primary endpoint in the VISUAL-I and VISUAL-II studies was time to treatment failure (TF), defined as having 1 or more of the following components present in at least 1 eye: increase in anterior chamber cells or vitreous haze, new chorioretinal or vascular lesions, or decrease in visual acuity. The VISUAL-I study found that, compared to placebo, patients on Humira were significantly less likely to experience TF (P<0.001). Median time to TF was prolonged by 87%, from 3 months for placebo to 5.6 months for Humira. In the VISUAL-II study, the median time to TF was 8.3 months for placebo and not estimable (>18 months) for Humira, as more than half of the Humira-treated patients did not experience TF (P=0.004). Last month, the European Commission approved Humira for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate.

ROP treatment fails to meet primary endpoint in phase 2 study

An investigational protein replacement, SHP607, did not meet its primary endpoint of reducing the severity of retinopathy of prematurity (ROP), developer Shire (Lexington, Massachusetts) said in a press release. SHP607 is a recombinant human version of the naturally occurring protein complex of insulin-like growth factor 1 (IGF-1) and its most abundant binding protein, IGF binding protein-3 (IGFBP-3). The phase 2 study included 121 extremely premature infants (born between 23 weeks and 27 weeks +6 days) randomized at birth to either SHP607 or standard neonatal care, and treated continuously until an equivalent gestational age of 30 weeks. Top-line data showed a 53% reduction in the incidence of severe bronchopulmonary dysplasia (BPD), as defined by oxygen challenge testing, in all assessed patients who received SHP607, as compared to untreated infants, and an 89% reduction in those who achieved the pre-specified target drug exposure, based on serum concentrations of IGF-1, as compared to untreated infants. The data also showed a 44% reduction in the incidence of severe intraventricular hemorrhage (IVH) (grade III and IV on centrally read ultrasounds) in all assessed patients who received SHP607, as compared to untreated infants, and a 64% reduction in those who achieved the pre-specified target drug exposure based on serum concentrations of IGF-1, as compared to untreated infants. The secondary endpoint of time to discharge from neonatal intensive care was not met. The study, however, demonstrated clinically relevant effects in secondary endpoints related to the development of severe BPD, a chronic lung disease, and severe IVH, a type of brain injury, both of which have lifelong negative implications for normal development. Later this year, Shire expects to begin discussions with regulatory authorities about a phase 3 clinical program focusing on clinically relevant complications of prematurity.

CF101 fails to meet glaucoma endpoints in phase 2 study

Top-line results from a phase 2 clinical trial of oral medication CF101 for the treatment of glaucoma found no statistically significant differences between the CF101 treated group and the placebo group in the primary endpoint of lowering intraocular pressure (IOP), developer Can-Fite (Petach Tikva, Israel) said in a press release. CF101 is a novel, first-in-class, A3 adenosine receptor agonist (A3AR) small molecule, orally bioavailable drug with a favorable therapeutic index. The randomized, double-masked, placebo-controlled, parallel-group phase 2 clinical trial was designed to evaluate the safety and efficacy of CF101 when administered orally twice daily for up to 16 weeks in patients with elevated IOP. A total of 89 patients were enrolled in the study. The study was conducted with 2 cohorts. In the first cohort, treatment was randomized in a 3:1 ratio of 1.0 mg CF101 to placebo. In the second cohort the CF101 dose was increased to 2.0 mg. CF101 is also in development for the treatment of autoimmune inflammatory diseases including rheumatoid arthritis (completed phase 2) and psoriasis (completed phase 2/3).

Google's DeepMind, Moorfields join forces to use AI to identify eye conditions

The U.K.'s Moorfields Eye Hospital NHS Foundation Trust and Google will analyze more than 1 million anonymous eye scans to train its computers to identify eye defects. The aim is to give physicians a digital tool that can read an eye scan test and recognize problems faster, Google said.

RESEARCH BRIEFS

  • Posterior capsule opacification (PCO) formation might not be attributed to the type of surgery, researchers say. C. Wertheimer and colleagues compared PCO by observing lens epithelial cell growth in the human capsular bag in vitro between conventional lens surgery using phacoemulsification (phaco) and femtosecond laser-assisted lens surgery (FLACS). Three groups consisting of 6 capsular bags were established: FLACS, phaco, and extracapsular lens extraction (ECCE). The capsular bag was transferred into equal cell culture conditions after using 1 of the defined surgical approaches. There was no statistically significant difference in time until cell coverage of the human donor capsular bag in vitro in all 3 surgical settings (ECCE vs. phaco p=0.6; ECCE vs. FLACS p=1.0; phaco vs. FLACS p=1.0). But the study did show that FLACS can be used for the human capsular bag model preparation and validates the human capsular bag model for future research. The study is published in Acta Ophthalmologica. 
  • Standard IOL power calculation used in regular phacoemulsification surgery is accurate in phacovitrectomy procedures in eyes with a wide range of axial length (AL) and a wide range of vitrectomy indications, with no tendency toward a myopic shift, according to Leonie van der Geest, MD, and colleagues. In their retrospective comparative case series, refraction results 1 month after phacovitrectomy (n=133) or phacoemulsification (n=132) were compared with predicted refractions calculated using the IOLMaster 500 (Carl Zeiss Meditec, Jena, Germany) and the Haigis formula. Outcomes after phacovitrectomy (−0.06±0.50 D) and phacoemulsification (−0.08±0.47 D) were comparable (P=0.74). The final postoperative refraction was within ±1.00 D of the preoperative refractive target in 94.9% and 94.6% of phacovitrectomy cases and phacoemulsification cases, respectively. Subgroup analysis found no increased risk for refractive surprises after gas tamponade or in eyes with an AL of 26.00 mm or greater. The study is published in the Journal of Cataract & Refractive Surgery.
  • The Baerveldt implant (Abbott Medical Optics, Abbott Park, Illinois) is more effective in both its surgical success rate and reducing glaucoma medication than the Ahmed glaucoma valve (AGV, New World Medical, Rancho Cucamonga, California), but it is comparable to the AGV implant in lowering intraocular pressure, according to S. Wang and colleagues. Their meta-analysis identified 929 patients from 6 studies. The weighted mean differences of the IOP reduction between the AGV implant and the Baerveldt implant were 1.58 at 6 months, -1.01 at 12 months, -0.54 at 24 months, and -0.47 at 36 months. No significant difference was detected between the 2 groups at any point in time. The Baerveldt implant was associated with a reduction in glaucoma medication at -0.51. There were no significant differences between the AGV implant and the Baerveldt implant on the rates of adverse events. The study is published in BMC Ophthalmology.

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: 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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