EW Weekly, July 12, 2019

Takeda completes sale of lifitegrast to Novartis
Takeda has completed its sale of lifitegrast ophthalmic solution 5% (Xiidra) to Novartis in a $3.4 billion deal with up to an additional $1.9 billion in potential milestone payments.

EyeGate files plan for dry eye-related study with FDA
EyeGate Pharmaceuticals has filed a protocol with the U.S. FDA regarding a follow-up pilot study using the Ocular Bandage Gel eye drop to treat punctate epitheliopathies, according to a company press release. After the review, the FDA will allow the company to begin study enrollment or provide comments to be addressed. The goal of the study is to evaluate various exploratory performance endpoints in punctate epitheliopathy patients.

Nicox signs agreement with Ocumension Therapeutics for NCX 4251 in China
Nicox and Ocumension Therapeutics have entered into an exclusive license agreement to develop and commercialize product candidate NCX 4251 (fluticasone propionate) in mainland China, Hong Kong, Macau, and Taiwan, according to a press release. The agent is currently in a Phase 2 trial in the U.S. in patients with acute exacerbations of blepharitis.

FDA approves eculizumab for adults with neuromyelitis optica spectrum disorder
The U.S. FDA has approved eculizumab (SOLIRIS) to treat neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 antibody positive. An estimated 73% of all patients with NMOSD test positive for anti-aquaporin-4 antibodies, according to a press release from Alexion Pharmaceuticals. The approval came after an expedited 6-month priority review from the U.S. FDA. Approval is based on results from the Phase 3 randomized, double-blind placebo-controlled PREVENT trial, published recently in the New England Journal of Medicine.

FDA accepts orphan New Drug Application for Brilliant Blue G ophthalmic solution
The U.S. FDA has accepted the orphan New Drug Application for Brilliant Blue G ophthalmic solution, according to a press release from Dutch Ophthalmic Research Center. The proposed use for Brilliant Blue G is to stain the internal limiting membrane. If approved, the solution will be the first FDA-approved product for this orphan indication, according to the company.

Enrollment completed for Phase 2 trial in Japan with netarsudil ophthalmic solution
Enrollment is complete in a Phase 2 clinical trial of netarsudil ophthalmic solution in Japan, according to a press release from Aerie Pharmaceuticals. Over 3 months, about 215 patients were randomized across four treatment arms: netarsudil ophthalmic solution 0.01%, netarsudil ophthalmic solution 0.025, netarsudil ophthalmic solution 0.04%, and placebo. The study's objective is to evaluate the IOP-reducing effect and safety of the three concentrations over a 28-day period. Topline data from the study are expected to be ready in the fourth quarter of this year.

Research briefs
  • Compared with vehicle, clinically and statistically significant improvements in tear production and ocular surface integrity were seen in patients treated with OTX-101 (cyclosporine A 0.09%, Sun Pharma) for dry eye in a Phase 3 trial, according to Damien Goldberg, MD, and coauthors. The randomized, multicenter, double-masked study included 744 patients, all of whom were adults with a history and clinical diagnosis of dry eye disease, a global symptom score of 40 or more, and a lissamine green conjunctival staining score of 3 to 9 (range, 0–12) in at least 1 eye. A significantly larger percentage of eyes in the OTX-101 treatment group had an increase of 10 mm or more in their Schirmer test score at day 84 (OTX-101 16.6%; vehicle, 9.2%; P<0.001). There also were significant improvements relative to vehicle for corneal and conjunctival staining. In both treatment groups, the global symptom score was reduced from baseline by approximately 30%. OTX-101 was well tolerated, and treatment-related adverse events were mild. The study is published in Ophthalmology.
  • Anterior chamber depth increased and was associated with concurrent refractive errors after cataract surgery, according to Xiaona Ning. The study from Dr. Ning and coresearchers focused on anterior chamber depth changes and their relationship with refractive errors after phaco and IOL implantation. The study included 145 eyes of 125 patients with age-related cataracts. Researchers measured axial length, anterior chamber depth, and lens thickness. Postop refraction results were obtained at 1 month. An appropriate formula was chosen for IOL power calculation depending on the axial length. Researchers found that anterior chamber depth deepened and tended to gradually stabilize after 2 weeks. A concurrent hyperopic shift was seen when the anterior chamber depth was less than 1.65 mm, but a myopic shift occurred contrarily. The difference between the two groups was statistically significant (P<0.0001). Postop anterior chamber depth and refractive changes were correlated with the preop depth and axial length, respectively. The researchers proposed two regression formulas: postoperative anterior chamber depth = 3.524 + 0.294 × preop anterior chamber depth and postop anterior chamber depth = 3.361 + 0.228 × (preop anterior chamber depth + ½ lens thickness). The study is published in BMC Ophthalmology.
  • When comparing post-cataract surgery anterior chamber inflammation after pretreatment with a femtosecond laser platform versus a manual procedure, anterior chamber flare was similar to that in controls, reported Eleonora Favuzza, MD, and coresearchers. In this prospective case series with 20 eyes in each group, aqueous humor was collected after femtosecond laser pretreatment (femtosecond group) and at the start of routine cataract surgery before the primary incision was created (control group). Using a multiplex array system, the levels of 14 cytokines and chemokines were measured. Surgical parameters were recorded, and anterior chamber flare was measured via laser photometry before surgery and at 1 and 7 days postop. The effective phaco time was significantly lower in the femtosecond group compared with the control group. Concentrations of interleukin (IL)-6, -8, -10, -12, vascular endothelial growth factor, and interferon-gamma were significantly higher in the control group. There was no significant difference in anterior chamber flare between the two groups at any timepoint. No correlation was found between cytokine concentrations and age in either group. The study is published in the Journal of Cataract & Refractive Surgery.

  • Product news
  • Carl Zeiss Meditec has received 510 (K) clearance from the U.S. FDA for the CLARUS 700 high-definition ultra-widefield imaging system.
  • Akorn has launched its generic version of loteprednol etabonate ophthalmic suspension 0.5%, according to a company press release.

This issue of EyeWorld Weekly was edited by Stacy Jablonski and Vanessa Caceres.

EyeWorld Weekly (ISSN 1089-0319), a digital publication of the American Society of Cataract and Refractive Surgery (ASCRS), 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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