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Volume 19, Number 35
10 October 2014




Allergic conjunctivitis drug fails to meet primary endpoints
Top-line results from a phase 2 study of a novel, topically administered interleukin-1 (IL-1) receptor blocker designed to bind and block the IL-1 receptor to prevent transmission of biological signals in patients with moderate to severe allergic conjunctivitis (EBI-005) did not meet its primary endpoint, developer Eleven Biotherapeutics (Cambridge, Mass., U.S.) said in a news release, noting the compound met secondary endpoints.
The company ran a phase 2 study using two distinct repetitive allergen challenge models: a modified Conjunctival Allergen Provocation Test (CAPT) model and a modified Environmental Exposure Chamber (EEC) model. In the CAPT model, patients treated with EBI-005 showed statistically significant improvements in mean change from baseline in patient-reported ocular itching compared to vehicle control, one of the secondary endpoints pre-specified in the statistical analysis plan, at the second to last (p=0.033) and final (p=0.045) assessment time points. This phase 2 study did not meet the primary endpoint of reduction in mean ocular itching in patients treated with EBI-005 compared to vehicle control in the EEC model.



Eylea granted FDA approval for ME following RVO
The U.S. Food and Drug Administration has granted approval to aflibercept (Eylea, Regeneron Pharmaceuticals, Tarrytown, NY, U.S.) for the treatment of macular edema following retinal vein occlusion (RVO), which includes both branch and central retinal vein occlusion. The approved dosage is 2 mg every 4 weeks, Regeneron said.



FDA grants priority review for DR drug
The U.S. Food and Drug Administration has granted priority review of ranibizumab (Lucentis, Genentech, South San Francisco, Calif., U.S.) for the treatment of diabetic retinopathy. The FDA confirmed action date is 6 February 2015. If approved by the FDA, Lucentis could be the first eye medicine available for diabetic retinopathy patients.



Aciex Therapeutics granted two patents
Aciex Therapeutics (Boston) has been issued two patents: one for AC-170 Cetirizine Ophthalmic Compositions and one for AC-155 Fluticasone Propionate Nano-crystalline Compositions. The first patent contains method of treatment claims that cover Aciex's cetirizine product candidate (cetirizine ophthalmic solution, 0.24%). The second contains both composition of matter and method of uses claims that broadly cover Aciex's novel nanocrystalline formulations of fluticasone propionate.
In July 2014, France-based Nicox purchased Aciex.



Alcon highlights European data on preventable disease for World Sight Day
World Sight Day, held on 9 October, is a global initiative to help raise awareness and address the problem of preventable blindness and vision impairment worldwide. To that end, Novartis (Basel, Switzerland) conducted "The Cost and Burden of Eye Diseases and Preventable Blindness" study quantifying the economic impact of vision loss by analyzing the top four eye diseases responsible for vision loss: glaucoma, diabetic retinopathy, cataracts, and wet age-related macular degeneration (AMD). A total of 14 countries were included in the study: Australia, Argentina, Denmark, France, Germany, Ireland, Italy, Mexico, Poland, Slovak Republic, Spain, Sweden, Switzerland, and the UK.
The analysis found that within the 14 countries studied, more than 350,000 healthy life years are lost due to cataracts, glaucoma, AMD, and diabetic retinopathy, equaling more than 123 million workdays lost per year. In addition, the annual economic costs due to preventable vision impairment and blindness totaled more than 20 billion EUR.



Nextech buys MDIntelleSys
Nextech Systems (Tampa, Fla., U.S.) has bought MDIntelleSys (Clearwater, Fla., U.S.), a leading cloud-based electronic health record (EHR) for ophthalmologists, the companies announced. Nextech will now offer both a client-server model and cloud-based solution to meet each practice's unique needs. Terms of the deal were not released.



RESEARCH BRIEFS
  • Monovision and multifocal IOL implantation provided excellent refractive outcomes for distance vision, according to a study published online in the Journal of Cataract & Refractive Surgery. G. Labiris and colleagues in Greece randomly assigned patients with a diagnosis of senile cataract with stage 2 nuclear opalescence to two groups: monovision (n=38) and multifocal (n=37) IOL implantation. Uncorrected (UDVA) and corrected (CDVA) distance visual acuity, Visual Function Index-14 (VF-14) scores, and spectacle dependence were assessed prior to surgery and 6 months postoperatively. Both techniques provided excellent refractive outcomes in UDVA and VF-14 scores (all P<0.01). No significant intergroup differences were detected in VF-14 scores at the final postoperative examination. The monovision group patients presented significantly more spectacle dependence for near vision but less glare.
  • Corneal crosslinking (CXL) reduces the corneal ablation depth of excimer lasers in the anterior 200 µm of the porcine cornea by approximately 12%, according to Olivier Richoz, MD, and colleagues. They divided ex vivo porcine corneas into two groups: the CXL group (n=30) and the control group (n=3). The experimental corneas underwent CXL including de-epithelialization, instillation of riboflavin solution for 25 minutes, and ultraviolet-A irradiation at 9 mW/cm2 for 10 minutes. The control group was de-epithelialized only. Four consecutive excimer laser ablations of 50 µm each were performed (AMARIS 750S, SCHWIND eye-tech solutions, Kleinostheim, Germany), and stromal bed thickness was measured with a built-in optical coherence pachymeter. To determine the potential influence of riboflavin, a third group (the riboflavin group, n=12) underwent de-epithelialization and instillation of riboflavin, but no ultraviolet-A irradiation. The mean individual ablation depth across the four ablations was significantly smaller in crosslinked corneas (−17%) when compared to untreated control corneas (P<0.001). A consistent reduction of 12% was observed via a cumulative analysis when assessing the relative isolated effect of CXL on the ablation rate. There was no significant effect from riboflavin in the deeper ablations, except for the first ablation (68.6±1.1 mm [range: 1 to 50 µm]). The group recommended further clinical studies in human corneas to confirm their findings. The study is published in the Journal of Refractive Surgery.
  • Loteprednol etabonate induction therapy 2 weeks before the initiation of long-term topical cyclosporine A (tCsA) treatment for chronic dry eye disease provides more rapid relief of dry eye signs and symptoms with greater efficacy than tCsA and artificial tears (AT) alone, according to John D. Sheppard, MD, and colleagues. They randomized 118 patients with dry eye disease to receive either loteprednol and tCsA (n=61), or AT and tCsA (n=57). Patients self-administered either loteprednol or AT for 2 weeks 4 times per day, followed by tCsA twice per day accompanied by either loteprednol twice per day or AT twice per day for an additional 6 weeks of treatment. Loteprednol etabonate pretreatment significantly reduced tCsA stinging (P<0.05). Both groups showed significantly improved OSDI scores at the 14-, 30-, and 60-day visits. Loteprednol etabonate showed significantly more OSDI improvement than AT. Both pretreatment strategies improved global self-assessment scores, Schirmer test, fluorescein staining, lissamine staining, and adjunctive AT use. Loteprednol etabonate showed superior improvement in Schirmer test, fluorescein staining, and lissamine staining. Intraocular pressure did not increase in either group. The study is published in Eye and Contact Lens.
NEW PRODUCT BRIEFS
  • Heidelberg Engineering (Heidelberg, Germany) introduced a new widefield optical coherence tomography (OCT) imaging modality for its Spectralis OCT family of products, the company announced. The new widefield OCT module expands the OCT field of view to 55 degrees and allows users to image the macula, the optic nerve head, and the periphery in one comprehensive examination, the company said.
  • Bausch + Lomb (Bridgewater, NJ, U.S.) has introduced the ZeroPhaco I/A handpiece, a first-of-its-kind device specifically designed for femto cataract surgery. The disposable I/A handpiece, with either 15-degree or 30-degree bevel needle, is designed for the removal of soft cataracts following femtosecond laser fragmentation without the use of ultrasonic energy, the company said.



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