EW Weekly, August 24, 2018

August 24, 2018
Volume 24 , Number 31

FDA approves dry eye drug from Sun Pharma

The U.S. Food and Drug Administration (FDA) has approved Cequa (cyclosporine ophthalmic solution 0.09%, Sun Pharma, Mumbai, India). The agent is indicated to increase tear production in patients with dry eye, according to a company press release. Cequa has the highest FDA-approved concentration of cyclosporine A and is the first approved cyclosporine product to incorporate nanomicellar technology, Sun Pharma reported. The nanomicellar technology facilitates entry into corneal and conjunctival cells, enabling the delivery of higher cyclosporine concentrations. In a Phase 3 confirmatory trial with Cequa, there was statistically significant improvement in Schirmer's score after 12 weeks of treatment. The agent is used twice daily and will be available as a single-use vial.

First agent in the U.S. for neurotrophic keratitis approved

Dompé (Milan, Italy) announced that the FDA has approved Oxervate (cenegermin-bkbj ophthalmic solution), a breakthrough therapy for neurotrophic keratitis. The efficacy and safety of Oxervate was established in two independent, double-masked, randomized, multicenter, controlled clinical trials. Both trials studied Oxervate monotherapy (20 mcg/mL) as compared to vehicle, a proxy for preservative-free artificial tears, among patients with moderate or severe neurotrophic keratitis. Study NGF0212, which was conducted in Europe, randomized 52 patients to each group. After 8 weeks, approximately 72% of patients in the treatment group were completely healed. Study NGF0214, conducted in the U.S., randomized 24 patients to each group, and 65.2% of treated patients were completely healed.

12-week dosing of aflibercept for AMD approved

The FDA has approved a supplemental Biologics License Application for aflibercept (Eylea, Regeneron Pharmaceuticals, Tarrytown, New York) using a modified 12-week dosing schedule. The application was based on second-year data from the Phase 3 VIEW 1 and 2 trials. Eylea is already approved for wet age-related macular degeneration for 4- to 8-week dosing intervals.

AAV-CNGB3 for achromatopsia receives Fast Track designation

The FDA has granted a Fast Track designation for the AAV-CNGB3 gene therapy product candidate (MeiraGTx, New York) to treat achromatopsia, which is caused by mutations in the CNGB3 gene. AAV-CNGB3 has already been granted an Orphan Drug designation by the FDA and an Orphan Medicinal Product designation by the European Medicines Agency.

Animal model shows effectiveness of gene therapy for retinitis pigments

A gene therapy used in dogs was effective at stopping vision loss and improving sight and could one day be effective in humans for retinitis pigmentosa, according to researchers at the University of Florida, Gainesville, Florida. The therapy uses the adeno-associated virus to silence the mutant rhodopsin gene that causes retinal degeneration while also delivering a normal, replacement copy of the gene, according to a university press release. The virus has already been shown to be safe in humans, but this is the first time that a gene therapy for retinitis pigmentosa has been tested in dogs, according to the release. The research findings are published in the Proceedings of the National Academy of Sciences.


  • There's a gap between outcomes in existing dry eye research and outcomes that patients consider important, reported Ian Saldanha, PhD, and fellow researchers. Their study focused on patient priorities for future dry eye research. Researchers identified research questions from a previous survey, identified outcomes from existing research, worked with a sample of patients with dry eye, conducted a two-round Delphi survey online, and designated and ranked questions and outcomes as important. A research question or outcome that was ranked by 75% of patients as 6 or higher on a scale of 0 to 10 was considered important. Most of the 420 patients were 60 years or older (56%), female (83%), and white (94%). Among 12 questions that clinicians had prioritized as important, patients agreed that eight of them were important. The top three questions were effectiveness of patient education, environmental modifications, and topical anti-inflammatory drops for dry eye. Among 109 outcomes from the research, patients rated 26 as important; 10 of those outcomes were uncommon in the existing research. Among the 10 most important outcomes, nine were associated with symptoms or quality of life. Ocular burning or stinging, ocular discomfort, and ocular pain were the three most important outcomes for patients. Future dry eye research should consider addressing research questions important to patients, the researchers concluded. The study is published in JAMA Ophthalmology.
  • A large proportion of keratoconjunctivitis is not associated with a detectable adenovirus, reported Cecelia Lee, MD, and coresearchers. Their retrospective analysis of clinical and molecular data was from NVC-422 Phase 2B, a randomized, controlled, masked trial for auricloscene (NovaBay Pharmaceuticals, Emeryville, California) for keratoconjunctivitis. The study included 500 participants from the U.S., India, Brazil, and Sri Lanka with a diagnosis of keratoconjunctivitis and positive rapid test results for adenovirus. Clinical signs and symptoms and bilateral conjunctival swabs were obtained, along with polymerase chain reaction (PCR) analysis. The main outcome measure was the difference in composite scores of clinical signs between days 1 and 18 as well as mean visual acuity change between days 1 and 18 and time to resolution for each symptom or sign. Seventy-eight percent of participants showed evidence of adenovirus by PCR. Adenovirus D species was most common (63%) among adenovirus-positive participants. Adenovirus D was associated with more severe signs and symptoms, a higher rate of subepithelial infiltrate development, and a slower decline in viral load. The clinical course of those with non-adenovirus D species infection and adenovirus-negative keratoconjunctivitis were similar. The mean visual acuity change was a gain of 1.9 letters between days 1 and 18, and there was a worse visual outcome associated with older age. The study is published in Ophthalmology.
  • In a study focused on the cost-effectiveness of intracameral moxifloxacin compared with traditional antibiotic prophylaxis to prevent endophthalmitis after cataract surgery, a topical perioperative antibiotic with a 500-microgram intracameral moxifloxacin costing $22 or less was both cost-effective and cost-saving from a societal perspective, reported Ella Leung, MD, and coresearchers. "From a healthcare sector perspective, a $20 intracameral moxifloxacin was cost-effective but not cost-saving," the authors wrote. When comparing costs, the authors used a base case of a healthy binocular 73-year-old male patient having first-eye cataract surgery. All costs and benefits found were adjusted 3% per annum and for inflation to 2017 U.S. dollars. Adjuvant intracameral moxifloxacin was more effective in improving quality-adjusted life years than topical antibiotics. The study is published in the Journal of Cataract & Refractive Surgery.
  • Glaucoma is the most prevalent neurodegenerative disease, but its mechanisms are not fully understood, reported Huihui Chen, and coresearchers. Using mice deficient in T- and/or B-cells and adoptive cell transfer, they showed that transient elevation of IOP was sufficient to induce T-cell infiltration in other retina. "This T-cell infiltration leads to a prolonged phase of retinal ganglion cell degeneration that persists after IOP returns to a normal level," according to the research. In mice and humans with glaucoma, heat shock proteins are identified as target antigens of T-cell responses; additionally, retina-infiltrating T-cells cross-react with human and bacterial heat-shock proteins. "Mice raised in the absence of commensal microflora do not develop glaucomatous T-cell responses or the associated neurodegeneration," the researchers wrote. These results provide evidence to show that glaucomatous neurodegeneration is mediated in part by T-cells that are presensitized by exposure to commensal microflora. The study is published in Nature Communications.

This issue of EyeWorld Weekly Update was edited by Amy Goldenberg and Vanessa Caceres.

EyeWorld Weekly Update (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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