EW Weekly, February 15, 2019

February 15, 2019
Volume 24 , Number 6

Leiter's and Mobius Therapeutics announce marketing and sales agreement for Mitosol

Leiter's 503B outsourcing facility and drug manufacturer Mobius Therapeutics announced a national sales and marketing agreement for Mitosol. Mitosol is the only FDA-approved formulation of mitomycin C with an ophthalmic indication. Leiter's is ceasing production of mitomycin C, as it has been deemed an essential copy, and will instead become a supplier of Mitosol. This agreement is designed to limit supply disruption for Leiter's customers.

Phase 3 study begins for new dry eye treatment from ReGenTree

The Phase 3 study ARISE-3 is now underway to study RGN-259 (ReGenTree), a treatment for dry eye, according to a company press release. ARISE-3 is a randomized, double-masked, placebo-controlled trial that will enroll 700 patients. Treatment is expected to be completed by the first half of 2020. The company ReGenTree is a joint venture between GtreeBNT and RegeneRx Biopharmaceuticals. The study will begin under an agreement with Ora Inc.

Study: Diet soda associated with higher risk of proliferative diabetic retinopathy

The consumption of more than four cans of diet soda per week is associated with a more than two-fold risk for proliferative diabetic retinopathy (PDR) in patients with diabetes, according to Eva Fenwick, PhD, and coauthors, in their clinical, cross-sectional study. The study included 609 adult patients recruited from a tertiary eye hospital and who answered a Food Frequency Questionnaire. Among the 609, 46.8% consumed diet soda regularly, and 31.2% consumed non-diet soda regularly. Also among the 609 participants, 37.8%, 5.9%, 25.3%, 4.6%, and 24% had no DR, mild nonproliferative DR, moderate nonproliferative DR, severe nonproliferative DR, and PDR, respectively. High diet soft drink consumption was independently associated with a higher likelihood of having PDR (odds ratio=2.51, 95% confidence interval=1.05-5.98) compared to those with no consumption. Regular soft drink consumption was not associated with diabetic retinopathy or diabetic macular edema. The study is published in Clinical & Experimental Ophthalmology.

Study: Prevalence of dry eye increasing at a younger age

In a prevalence and incidence study, the overall dry eye disease prevalence was 5.28%, reported Reza Dana, MD, and coauthors in their retrospective analysis. Researchers used data from the Department of Defense Military Health System beneficiary medical claims from 2003 to 2015. Researchers tracked overall dry eye disease prevalence, annual prevalence, and annual incidence grouped by age, sex, and ICD-9 diagnosis code grouping. The overall prevalence was 7.78% among females and 2.96% among males. The prevalence increased with age, from 0.20% for those age 2 to 17 years to 11.66% among those age 50 or over. The annual prevalence increased from 0.8% to 3.0% overall; there also was an increased annual prevalence across age groups starting in the age 18 to 39 category. The findings highlight the importance of continued research and therapeutic development for dry eye, the researchers concluded. The study is published in the American Journal of Ophthalmology.

Orphan Drug Designation granted for OCU400 gene therapy for retinal degenerative disease

The U.S. Food and Drug Administration (FDA) has granted an Orphan Drug Designation for OCU400 (Ocugen), a gene therapy to treat NR2E3 mutation-associated retinal degenerative disease, the company reported in a press release. OCU400 consists of adeno-associated virus serotype 5 capsid containing the gene for human nuclear hormone receptor NR2E3 and is the first program that Ocugen is advancing based on its modifier gene therapy platform, according to the press release.

Precizon Presbyopic IOL with Continuous Transitional Optics patented in the U.S.

The U.S. Patent Office has given a patent for the aspheric presbyopia-correcting Precizon Presbyopic IOL (Ophtec) for its Continuous Transitional Focus optical design. The lens currently has European CE mark approval and is available in South Korea and South Africa. It is not yet available in the U.S.

Fast Track Designation given for macular telangiectasia type 2 treatment

The U.S. FDA has granted a Fast Track Designation for NT-501 (Renexus, Neurotech Pharmaceuticals) for macular telangiectasia type 2. Two parallel Phase 3 studies with the drug are currently enrolling patients in the U.S., Australia, and Europe.

Research briefs

  • Sleep quality may have an important role in dry eye development, according to Mengliang Wu, MD, and coresearchers, based on the results of their recent study, which included 106 consecutive patients with dry eye and age- and sex-matched healthy controls (n=50). The study evaluated sleep and mood status and analyzed the association among sleep quality, mood status, and ocular surface characteristics. Tear fluid breakup time, corneal fluorescein staining, and Schirmer I tests were performed to analyze dry eye. The mean Pittsburgh Sleep Quality Index global score was significantly higher in patients with dry eye disease than in controls. Patients with dry eye also had higher depression and anxiety scores compared with controls. Those with poor sleep quality had more severe dry eye as indicated by shorter tear fluid breakup time and lower Schirmer I findings. More severe dry eye symptoms were significantly associated with higher anxiety levels in dry eye patients. Sleep quality may influence tear secretion and tear film stability and/or by indirectly aggravating anxiety and depression, which could lead to higher self-reported symptom scores, the researchers included. The study is published in Cornea.
  • A higher consumption of certain vitamins and carotenoids was associated with a significantly lower risk of age-related cataract in cohort studies, but evidence from randomized controlled trials was less clear, reported Hong Jiang and coresearchers. Their meta-analysis looked at both types of studies, for a total of eight randomized controlled trials and 12 cohort studies. Vitamin A, vitamin C, vitamin E, beta carotene, and lutein or zeaxanthin were associated with a reduced risk of age-related cataract in the cohort studies. In the randomized controlled trials, vitamin E and beta carotene did not significantly lower the risk of age-related cataract compared with placebo. Further dose-response analysis showed that the risk of age-related cataract significantly lowered by 26% for every 10 mg/d increase in lutein or zeaxanthin intake in the cohort studies. Similar effects were seen with other vitamins, although to a lesser percentage. The study appears in the American Journal of Clinical Nutrition.
  • In mild to moderate myopia, small incision lenticule extraction (SMILE, Carl Zeiss Meditec) offers predictable correction of spherical equivalent refractive error, according to Alper Ağca and coresearchers in their retrospective case series focusing on long-term efficacy and safety of SMILE. Patients with a preop spherical equivalent of manifest refraction of 6 D or less and a 5-year follow up were included in the study. Uncorrected and corrected distance visual acuities and spherical equivalent were analyzed preoperatively and at 1, 3, and 5 years postop. Among 54 eyes (34 patients), the mean spherical equivalent of the intended correction was -4.11 D and ranged from -1.38 to -5.88 D. The mean preop uncorrected distance visual acuity and corrected distance visual acuity were 1.08 logMAR and 0.02 logMAR, respectively. The mean difference between the intended and achieved spherical equivalent was -0.13 D at the 5-year follow up; also at 5 years, the spherical equivalent was within ±0.50 D of the intended correction in 93% of patients and within ±1 D of the intended correction in all patients. No patient lost corrected distance visual acuity or had vision-threatening events. The study is published in the Journal of Cataract & Refractive Surgery.

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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