EW Weekly, January 10, 2020

Enrollment underway in VISTA-2 Phase 3 trial for dry eye
Mitotech and Essex Bio-Technology have enrollment underway for the Phase 3 study VISTA-2, which will use their SkQ1 compound in patients with moderate to severe dry eye disease, according to a press release. SkQ1 is part of a class of cardiolipin peroxidation inhibitors that Mitotech has under development. VISTA-2 builds on results from the Phase 2b/3 VISTA-1 trial, which included 450 patients. The multicenter, randomized, double-blind, placebo-controlled VISTA-1 trial met multiple predetermined secondary endpoints and showed broad action of SkQ1 in the intent-to-treat population. The nominal coprimary endpoints of VISTA-1, fluorescein staining in the central corneal zone and grittiness, were not met. Compared with vehicle, SkQ1 had statistically significant reduction of ocular discomfort. VISTA-2 will have a similar design as VISTA-1 but will have two instead of three treatment arms. There will be 300 patients per arm.

Phase 2 results announced for NCX 4251 blepharitis treatment
In a Phase 2 trial of NCX 4251 (Nicox), researchers were able to select the dose of NCX 4251 to advance to the next stage of development. NCX 4251 was designed for blepharitis. A 0.1% once-daily dose was selected to move on to the larger Phase 2b trial, pending the outcome of a meeting with the U.S. FDA early this year, according to a company press release. In the Phase 2 trial, both once-daily and twice-daily doses of 0.1% were well tolerated. The dose they selected also showed promising efficacy against exploratory endpoints in the study for the reduction of the signs and symptoms of dry eye disease. NCX 4251 is a patented ophthalmic suspension of fluticasone propionate nanocrystals.

First patient treated in Phase 2 program for IVIEW-1201 for acute adenoviral conjunctivitis
The first patient has been treated in a Phase 2 IVIEW-1201-01-A1C clinical trial program focused on the efficacy of IVIEW-1201 (iView Therapeutics) in patients with acute adenoviral conjunctivitis. The Phase 2 study is planned to take place in the U.S., India, and China simultaneously. IVIEW-1201 is an in-situ gel forming ophthalmic solution with in-vitro efficacy against many bacteria, yeasts, fungi, and human adenovirus, according to the company. The current study’s objective is to evaluate the efficacy of IVIEW-1201 as first-line treatment for ocular infection in the setting of an acute adenoviral conjunctivitis infection.

Enrollment completed in follow-on pilot study for punctate epitheliopathies
EyeGate Pharmaceuticals has completed enrollment in the company’s follow-on pilot study for punctate epitheliopathies with a focus on dry eye patients. The study will use the Ocular Bandage Gel eye drop to treat patients with punctate epitheliopathies and evaluate different exploratory performance endpoints. Once data from the study are ready, EyeGate leaders plan to meet with FDA officials to discuss results and confirm the ideal endpoint to use in the study. Data from the study are expected in the first quarter of this year.

Roclanda marketing application accepted in Europe
The marketing authorization application for Roclanda (netarsudil and latanoprost ophthalmic solution, Aerie Pharmaceuticals) has been accepted by the European Medicines Agency, according to an Aerie press release. Roclanda is currently marketed as Rocklatan in the U.S. If approved, Roclanda would be the first fixed-dose combination of its kind in Europe, the company reported. Company leaders expect to complete and analyze the related Mercury 3 study in the second half of this year.

Generic travoprost solution approved
The FDA has approved a generic version of travoprost ophthalmic solution 0.004% (Alembic Pharmaceuticals).

Merger agreement announced between Quantel Medical, Ellex
The parent company of Quantel Medical, Lumibird Group, has announced an agreement with Ellex Medical Lasers to acquire the laser and ultrasound business from Ellex for approximately $69 million. If approved, Lumibird Group will acquire all of Ellex’s laser and ultrasound activities as well as the Ellex brand, an R&D and production site in Adelaide, Australia, and commercial subsidiaries in Australia, Japan, the U.S., France, and Germany. The acquisition will be submitted to shareholders from Ellex in the first half of this year.

Topline data announced from Phase 1 study for DME treatment
In a Phase 1 study, THR-687 (Oxurion) for diabetic macular edema and diabetic retinopathy was well-tolerated and safe. The open-label, multicenter, single-dose escalation study assessed the safety of a single intravitreal injection of three increasing doses of THR-687 (0.4 mg, 1.0 mg, and 2.5 mg). Across all doses, researchers observed a fast onset of action in the mean best corrected visual acuity (BCVA) from day 1 with an increase of 3.1 letters, improving to 9.2 letters at month 1. This activity was maintained with a mean BCVA improvement of 8.3 letters at month 3 after a single injection. Patients in the study had a history of response to prior anti-vascular endothelial growth factors and/or corticosteroid treatment. THR-687 is a pan-RGD integrin antagonist.

First patient enrolled in Phase 3 GUARD trial for proliferative vitreoretinopathy
The first patient has been enrolled in the Phase 3 GUARD trial for ADX-2191 (Aldeyra Therapeutics) to help prevent proliferative vitreoretinopathy. GUARD is a two-part, multicenter, randomized trial that will evaluate the efficacy of intravitreal injections of ADX-2191 versus standard of care to prevent proliferative vitreoretinopathy.

Research briefs
  • A meta-analysis of randomized controlled trials with accelerated corneal collagen crosslinking (CXL) and standard corneal CXL found a comparable efficacy and safety profile after 1 year of follow-up, reported Hidenaga Kobashi, MD, and Kazuo Tsubota, MD. However, accelerated CXL had less impact on improving best spectacle-corrected visual acuity (BSCVA) compared with the Dresden protocol. Researchers identified six randomized controlled trials that evaluated the clinical outcomes of accelerated CXL and standard CXL for the treatment of progressive keratoconus. With standard CXL, there was a significantly better outcome in postop changes in BSCVA, but the differences may not be clinically significant, the researchers reported. There was a significantly better improvement of cylindrical refraction with accelerated CXL after 1 year of follow-up. The demarcation line depth at 1 month after standard CXL was deeper than that after accelerated CXL. No differences in maximum keratometry, central corneal thickness, uncorrected visual acuity, spherical equivalent refraction, corneal biomechanical properties, and corneal endothelial cell density were found. The research appears in Cornea.
  • A better understanding of seasonal influences on postop infection might help with risk stratification and outcome improvisation, according to Soo Han Kim, MD, and fellow researchers. Their retrospective cohort study of endophthalmitis in South Korea found that incidences of post-cataract surgery endophthalmitis were higher during the hot and humid months. Researchers reviewed claims data from July 2014 to June 2017 and obtained monthly climate data. Incidences of endophthalmitis were assessed by month and by season. The association between postop endophthalmitis and climatic variables including mean temperature, relative humidity, precipitation, and hours of sunshine also were analyzed. Although there were fewer cataract surgeries performed in the warm summer months, incidences of endophthalmitis were higher in the summer months. Endophthalmitis tended to rise with increasing relative humidity and increasing precipitation. The study is published in the Journal of Cataract & Refractive Surgery.

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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