Vitamin B2

Pregnant women eating modern diets are missing key nutrients needed for them and their babies, and this could get worse with the move to plant-based foods. Scientists surveying more than 1,700 women found most were missing vitamins usually found in meat and dairy, including B12, B6 and D, folic acid and riboflavin which are essential for the development of fetuses in the womb. Pregnant women are not getting the essential nutrients they and their babies need from modern diets say scientists, who have warned that the situation will likely worsen as more people turn to plant-based foods. A study looking at the health of expecting mothers from high-income countries, including the UK, New Zealand and Singapore, found that 90 per cent were lacking key vitamins necessary for healthy pregnancies and the wellbeing of unborn infants. Scientists from the University of Southampton, working with experts worldwide, surveyed more than 1,700 women and found most were missing essential nutrients found in abundance in meat and dairy products. These included vitamins B12, B6 and D, folic acid and riboflavin which are essential for the development of foetuses in the womb. Lead author and Professor of Epidemiology Keith Godfrey, from the University of Southampton, said the prevalence of vitamin deficiencies among women attempting to become pregnant in wealthy countries is a serious concern. He added: "The push to reduce our dependence on meat and dairy to achieve net-zero carbon emissions is likely to further deplete expecting mothers of vital nutrients, which could have lasting effects on unborn children. "Our study shows that almost every woman trying to conceive had insufficient levels of one or more vitamin, and this figure is only going to get worse as the world moves towards plant-based diets. "People think that nutrient deficiency only affects people in underdeveloped countries -- but it is also affecting the majority of women living in high-income nations." The study, which was published in PLOS Medicine, assessed 1,729 women between the ages of 18 and 38 at conception and followed many during subsequent pregnancies. It was undertaken by researchers from Southampton and its National Institute for Health and Care Research (NIHR) Biomedical Research Centre, the University of Auckland, National University of Singapore, and Agency for Science, Research and Technology, Singapore. Results showed that nine out of ten women had marginal or low levels of folate, riboflavin, vitamins B12 and D around the time of conception, and that many developed vitamin B6 deficiency in late pregnancy. Co-author Professor of Paediatric Endocrinology Wayne Cutfield, from the University of Auckland, said while folic acid is recommended for women planning conception and during pregnancy, expecting mothers should be given over-the-counter multivitamins to reduce nutrient deficiencies. He added: "The wellbeing of a mother ahead of conceiving and during a pregnancy has a direct influence on the health of the infant, their lifelong physical development, and ability to learn." The PLOS Medicine trial was the first to show that supplements, available over the counter, can reduce vitamin insufficiencies during the preconception, pregnancy and lactational periods. Associate Professor Shiao-Yng Chan at the National University of Singapore said: "If we continue to move towards diets with less meat and dairy products, reducing intakes of micronutrients essential for a child's development, vitamin deficiencies will continue to grow unless women start taking more supplements or are supported with specific advice about nutrient-rich foods."

Enrollment Completion Achieved in Less Than Six Months from Trial Commencement, Ahead of Original Timing Expectations Phase 3 Confirmatory Trial Results Together with Already-Completed First Phase 3 Trial Expected to Support Glaukos’ Targeted NDA Submission for Epioxa by the End of 2024 ALISO VIEJO, Calif.--(BUSINESS WIRE)-- Glaukos Corporation (NYSE: GKOS), an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases, today announced the completion of enrollment and randomization in its second Phase 3 confirmatory pivotal trial for Epioxa™ (Epi-on), its next-generation corneal cross-linking therapy for the treatment of keratoconus. “The expeditious enrollment completion in the Epioxa Phase 3 confirmatory trial, which only commenced earlier this year, is a testament to the favorable risk-benefit pro this next-generation therapy as well as our team’s hard work in bringing this important therapy one step closer to patients suffering from keratoconus, a sight-threatening corneal disease,” said Thomas Burns, Glaukos chairman and chief executive officer. “We appreciate the commitment and dedication of the clinical investigators, who played a vital role in helping to achieve this enrollment milestone ahead of our original timing expectations. We look forward to following these patients’ outcomes as we target a U.S. New Drug Application (NDA) submission for Epioxa by the end of 2024.” The Epioxa multi-center, randomized, placebo and sham procedure controlled, Phase 3 confirmatory pivotal trial randomized 312 eyes and was designed to evaluate the safety and efficacy of Glaukos’ Epioxa therapy in impeding the progression of, and/or reducing maximum corneal curvature (Kmax) in eyes with progressive keratoconus. Kmax is an objective measurement of the steepest corneal curvature based on corneal topography, where an increasing Kmax denotes corneal steepening and keratoconus disease progression. The study eyes were randomized in a 2:1 ratio to receive Epioxa therapy or placebo and sham procedure control treatment. The study’s primary efficacy endpoint is the mean change in Kmax from baseline to Month 12. Based on an agreement with the U.S. Food and Drug Administration (FDA), the study will be considered a success if the difference between the treatment and control arm in the primary efficacy endpoint is statistically significant and the difference is ≥ 1.0 diopter (D). Results from this second Phase 3 confirmatory pivotal trial together with the already-completed first Phase 3 pivotal trial are expected to support Glaukos’ targeted NDA submission for Epioxa by the end of 2024. As a reminder, the U.S. FDA has confirmed Glaukos’ first Phase 3 pivotal trial for Epioxa, which met the pre-specified primary efficacy endpoint, would be adequate to support the submission and review of an eventual NDA, in conjunction with this second Phase 3 trial. As Glaukos continues to advance its clinical plans for Epioxa, it remains well-positioned to serve keratoconus patients with its first-generation corneal cross-linking therapy, Photrexa®, or Epi-off, which remains the only FDA-approved treatment shown to slow and halt the progression of keratoconus. About Glaukos Glaukos ( ) is an ophthalmic medical technology and pharmaceutical company focused on developing and commercializing novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases. Glaukos first developed Micro-Invasive Glaucoma Surgery (MIGS) as an alternative to the traditional glaucoma treatment paradigm, launching its first MIGS device commercially in 2012, and continues to develop a portfolio of technologically distinct and leverageable platforms to support ongoing pharmaceutical and medical device innovations. Products or product candidates for each of these platforms are designed to advance the standard of care through better treatment options across the areas of glaucoma, corneal disorders and retinal diseases. Forward-Looking Statements All statements other than statements of historical facts included in this press release that address activities, events or developments that we expect, believe or anticipate will or may occur in the future are forward-looking statements. Although we believe that we have a reasonable basis for forward-looking statements contained herein, we caution you that they are based on current expectations about future events affecting us and are subject to risks, uncertainties and factors relating to our operations and business environment, all of which are difficult to predict and many of which are beyond our control, that may cause our actual results to differ materially from those expressed or implied by forward-looking statements in this press release. These potential risks and uncertainties include, without limitation, the timing and extent to which we obtain regulatory approval for investigational products such as Epioxa, our ability to successfully commercialize such products, the ability to obtain and maintain adequate financial coverage and reimbursement for this product, and the continued efficacy and safety pro this product as reported in the pivotal trials and other clinical studies. These and other risks, uncertainties and factors related to Glaukos, and our business are described in detail under the caption “Risk Factors” and elsewhere in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2023, which was filed with the Securities and Exchange Commission (SEC) on May 4, 2023. Our filings with the SEC are available in the Investor Section of our website at or at . In addition, information about the risks and benefits of our products is available on our website at . 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