This randomized clinical trial will assess corneal astigmatism and visual outcomes in participants who have undergone corneal transplantation for keratoconus with ex vivo cross-linked donor corneal tissue versus participants who have undergone corneal transplantation for keratoconus with non-cross-linked donor corneas. Crosslinking is a procedure that stabilizes the biomechanical properties of the cornea; as a result, the cornea stiffens. It has been shown that this procedure stabilizes the cornea of patients with keratoconus or corneal ectasias. The FDA currently approves crosslinking for patients with progressive keratoconus and corneal ectasia following refractive surgery. Ex vivo crosslinking of donor corneal tissue for patients with keratoconus undergoing PK or DALK could stabilize the cornea and reduce the risk of high astigmatism and improve vision in patient with keratoconus.

Start Date01 Dec 2023

Sponsor / Collaborator

Massachusetts Eye & Ear Infirmary, Inc.

NCT04481841

/ Unknown statusEarly Phase 1IIT

Head Yuanshi Dian Therapy in the Treatment of Burning Mouth Syndrome: a Randomized Controlled Trial

Burning mouth syndrome is one of the most common oral mucosal diseases in clinic. It is a chronic pain syndrome with extensive burning pain of oral mucosa as its main symptoms. There are no pathological changes in oral mucosa and no characteristic histopathological changes. Patients often have accompanying symptoms such as depression and xerostomia. Although the patient does not have obvious oral lesions, the pain symptoms are more serious and the mental pressure is greater.
BMS, as a complex clinical syndrome associated with multiple factors, mainly occurs in people aged 27-87, with an average age of 61. BMS is rare among people under 30 years old. BMS is predominant in women, the ratio of male to female is 1:5 to 1:7, the incidence is 0.7%-15%, and increases with age. Up to 90% of female patients are in perimenopausal period. Symptoms occur from 3 years before menopause to 12 years after menopause.
The causes of BMS are complex, and the treatment is difficult, easy to relapse and protracted. Studies have confirmed that the occurrence and development of BMS are directly related to mental factors. Therefore, psychosocial factors are the most important pathogenic factors of BMS. If we intervene in these factors, it is hopeful to improve the curative effect of BMS.
Traditional psychotherapy methods include drug treatment, psychotherapy, surgical treatment, traditional Chinese medicine treatment, etc. Drug treatment is mainly based on different types of mental and psychological diseases, choose different pharmacological effects of drugs, so as to effectively control the disease. However, these drugs are prone to adverse reactions such as sleepiness, weight gain, headache, physical weakness, etc. The basic principle of psychotherapy is to let patients fully expose symptoms, listen to their complaints patiently, carry out explanatory psychotherapy according to their medical history or take other psychological training, so as to relieve patients' mental stress and alleviate symptoms. But this method has a long course of treatment and needs the cooperation of the patients' family members; the basic principle of surgical treatment is to resect the corresponding areas of the brain or adopt endoscopy and micro-current to treat them, but the risks and injuries caused by the operation are greater, and the adverse reactions after the operation are larger; the treatment of traditional Chinese medicine needs a long course of treatment, and the treatment of some patients. The effect is not stable enough.
The causes of BMS are complex, there is no objective disease in clinic, and the patients suffer from abnormal pain, but the treatment methods are not uniform, and the curative effect is not good, which makes the patients unable to get effective treatment in the early stage of the disease, and easy to relapse, resulting in the aggravation and development of BMS into intractable sensory abnormalities, and protracted! Literature reports confirm that the tri-drug of oryzanol-riboflavin-vitamin E (oryzanol-riboflavin-vitamin E) is a classic treatment for BMS and has been included in the classic book in China, Pharmacotherapy for oral mucosal disease . However, its long-term clinical application has found that its efficacy is unstable, and clinical symptoms after drug withdrawal. The symptoms are prone to recurrence or even aggravation. Therefore, it is necessary to use the classical program on the basis of a combination of interventions to promote the efficacy of stable and safe.
Over the past two years, the investigators has treated nearly 100 cases of BMS with head yuanshi dian therapy, and achieved satisfactory results. It can obviously relieve burning pain of BMS oral mucosa, promote saliva secretion, improve dry mouth and bitter mouth, and improve sleep to a certain extent. However, due to the limited number of cases treated, the classification of BMS is not meticulous enough, and there are still vague areas in the classification of BMS, which affects the rigorous evaluation of the therapeutic effect of BMS.
Therefore, the investigators propose a hypothesis: can the head yuanshi dian therapy be used as the main adjuvant therapy for BMS? By consulting Pubmed, OVID, CNKI, Wanfang and other major databases at home and abroad, the investigators found that there is no relevant report at home and abroad. In view of this, the investigators intend to design this randomized positive controlled clinical trial, using conventional valley-nucleus-E triple drug therapy as the positive control group, to observe the efficacy and safety of head yuanshi dian therapy for BMS, in order to find a safe and effective green non-invasive therapy, effectively alleviate or eliminate oral mucosal pain, dry mouth, etc.

Start Date27 Jul 2020

Sponsor / Collaborator

Second Affiliated Hospital Zhejiang University College of

[+1]

NCT03245853

/ CompletedPhase 4

Epithelium-On Corneal Collagen Crosslinking for Keratoconus

Epithelium-On Corneal Crosslinking for Keratoconus.

Start Date18 Jul 2017

Sponsor / Collaborator

Eyecare Specialties of Ohio

[+1]

100 Clinical Results associated with Riboflavin 5'-Phosphate Sodium

100 Translational Medicine associated with Riboflavin 5'-Phosphate Sodium

100 Patents (Medical) associated with Riboflavin 5'-Phosphate Sodium

1,201

Literatures (Medical) associated with Riboflavin 5'-Phosphate Sodium

01 Mar 2025·New Biotechnology

Strategic improvement of Shewanella oneidensis for biocatalysis: Approach to media refinement and scalable application in a microbial electrochemical system

Article

Author: Edel, Miriam ; Knoll, Melanie T ; Gescher, Johannes ; Weiler, Janek R ; Juergensen, Nikolai

Microbial electrochemical systems offer a sustainable method for the conversion of chemical energy into electrical energy or hydrogen and the production of valuable compounds, contributing to the development of a bio-based economy. This study aimed to enhance the performance of anodic bioelectrochemical systems by improving the current density of Shewanella oneidensis as a biocatalyst through strain modification and medium refinement. The genetic modification, combining the prophage deletion and overexpression of the speC gene, resulted in a 4.2-fold increase in current density compared to the wild type. Furthermore, medium refinement and incorporating riboflavin, led to an additional 5.7-fold increase in current density. The application of the modified strain and medium in a scalable microbial electrolysis cell resulted in a current density of 1.2 A m^-², similar to what was achieved previously with an S. oneidensis and Geobacter sulfurreducens co-culture, substantiating the substantial performance increase for a pure culture of S. oneidensis. Furthermore, S. oneidensis was shown to grow in medium containing up to 500 mM sodium chloride and increasing the salt concentration to 400 mM had a minor influence on growth but significantly lowered the cell voltage of the MEC system.

01 Mar 2025·Brain Research

Effect of electroacupuncture on metabolic alterations in the hippocampus and dorsal raphe nucleus of Wistar Kyoto rats

Article

Author: Li, Xiang ; Zhang, Wei ; Zeng, Xiaoling ; Xu, Wenqing ; Li, Wei ; Xu, Shifen ; Cui, Kaiyu ; Yin, Xuan

Depression is underpinned by a complex pathogenesis that involves the hippocampus and dorsal raphe nucleus (DRN) of the central nervous system. Although electroacupuncture (EA) is proven to be safe and effective for alleviating depression symptoms and causes minimal side effects, its underlying therapeutic mechanism remains unclear. In this study, we performed targeted metabolomics to identify metabolite alterations in the hippocampus and DRN of Wistar Kyoto (WKY) rats and elucidate the role and potential mechanism of action of EA. Our results indicated that 3 weeks of consecutive EA significantly ameliorated depression-like behaviors in WKY rats. Targeted metabolomics revealed 42 differentially expressed metabolites (DEMs) in the hippocampus and 97 DEMs in the DRN between Wistar and WKY rats. In addition, we observed 19 hippocampal DEMs and 41 DRN DEMs between WKY and EA-treated rats. Subsequent pathway analyses indicated that these DEMs were primarily enriched in amino acid-related metabolic pathways. Moreover, six DEMs were found to be significantly associated with at least one depression-like behavior, indicating their involvement in the pathogenesis of depression. EA intervention modulated the levels of 1-methylhistidine, 3-methylhistidine, carnosine, and riboflavin in depressed rats. Collectively, these findings demonstrate that disturbances in cerebral metabolites, especially amino acids, may be one of the causes underlying depression in WKY rats, and the therapeutic effect of EA is potentially mediated through the modulation of the levels of these metabolites.

01 Feb 2025·Nutrition Reviews

Effects of deficiency or supplementation of riboflavin on energy metabolism: a systematic review with preclinical studies

Review

Author: da Silva-Araújo, Eulália Rebeca ; de Freitas Silva, Sebastião Rogério ; Souza, Vanessa da Silva ; Gouveia, Henrique José Cavalcanti Bezerra ; Toscano, Ana Elisa ; Silva, Paula Brielle Pontes ; da Silva, Márcia Maria ; Pereira dos Santos Junior, Joaci ; Manhães-de-Castro, Raul

AbstractContextRiboflavin (vitamin B2) is a water-soluble micronutrient considered to be a precursor of the nucleotides flavin adenine dinucleotide and flavin mononucleotide. This vitamin makes up mitochondrial complexes and participates as an enzymatic cofactor in several mechanisms associated with energy metabolism.ObjectiveThis systematic review collected and discussed the most relevant results on the role of riboflavin in the energy metabolism of lipids, proteins, and carbohydrates.Data SourcesA systematic search was carried out in the PubMed-Medline, Scopus, Embase, and Web of Science databases using the PICOS (Population, Intervention, Comparison, Outcome, Study design) strategy.Data ExtractionThe screening of studies went through 2 stages following predefined eligibility criteria. The information extracted covered reference details, study design, population characteristics, experimental model, treatment parameters and dosage, route of administration, duration of treatment, and results found.Data AnalysisThe risk of bias was assessed using the SYRCLE Risk of Bias (RoB) tool for in vivo studies and the QUIN tool adapted for in vitro studies, utilizing 10 domains, including selection bias, performance bias, detection bias, attrition bias, reporting bias, and other biases, to evaluate the methodological quality of the included studies.ConclusionThis review concludes that riboflavin regulates energy metabolism by activating primary metabolic pathways and is involved in energy balance homeostasis.

News (Medical) associated with Riboflavin 5'-Phosphate Sodium

23 Dec 2024

·www.businesswire.com

Glaukos Submits New Drug Application to U.S. FDA for Epioxa™

ALISO VIEJO, Calif.--( BUSINESS WIRE )--Glaukos Corporation (NYSE: GKOS), an ophthalmic pharmaceutical and medical technology company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases, today announced the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Epioxa™ ( Epi-on ), its next-generation corneal cross-linking iLink therapy for the treatment of keratoconus, a progressive, sight-threatening corneal disease. “The NDA submission for Epioxa represents an important milestone for our company as it brings us one step closer in being able to provide keratoconus patients and the ophthalmic community with the first FDA-approved, non-invasive corneal cross-linking drug therapy that does not require removal of the corneal epithelium, the outermost layer of the front of the eye,” said Thomas Burns, Glaukos chairman and chief executive officer. “We look forward to working closely with the FDA in their pending review process and continue to believe Epioxa , which is designed to reduce procedure times, improve patient comfort and shorten recovery time, represents a potentially meaningful advancement in the treatment paradigm for patients suffering from keratoconus.” The NDA submission includes data from two Phase 3 pivotal trials of Epioxa, which both successfully achieved the pre-specified primary efficacy endpoints and demonstrated favorable tolerability and safety profiles. Glaukos’ corneal cross-linking iLink therapies use proprietary, bio-activated drug formulations designed to strengthen corneal tissue and halt progression of keratoconus. Typically diagnosed in a patient’s teenage years, keratoconus is a debilitating eye condition characterized by progressive thinning and weakening of the cornea. If left untreated, keratoconus can lead to loss of vision and even blindness and is one of the leading causes of corneal transplant (penetrating keratoplasty) in the United States. Approximately 90% of cases of keratoconus are bilateral and as many as 20% of patients ultimately require a corneal transplant. Conventional keratoconus treatments such as eyeglasses or contact lenses address symptoms but Glaukos’ first-generation iLink therapy, known as Photrexa ® , or Epi-off , is the first and only FDA-approved therapy that has been shown to slow or halt disease progression. There are more than 300 peer-reviewed publications supporting the performance and safety of Glaukos’ iLink therapy. Epioxa, which is designed to preserve the corneal epithelium, reduce procedure times, improve patient comfort and shorten recovery time, utilizes a proprietary, novel drug formulation designed to penetrate the epithelial layer of the cornea, a stronger UV-A irradiation protocol and supplemental oxygen to enhance cross-linking. If approved, the company anticipates Epioxa would be the first FDA-approved, non-invasive corneal cross-linking therapy that does not require removal of the corneal epithelium, the outermost layer of the front of the eye. About Glaukos Glaukos ( www.glaukos.com ) is an ophthalmic pharmaceutical and medical technology 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. In 2024, Glaukos commenced commercial launch activities for iDose ® TR , a first-of-its-kind, long-duration, intracameral procedural pharmaceutical designed to deliver 24/7 glaucoma drug therapy inside the eye for extended periods of time. Glaukos also markets the only FDA-approved corneal cross-linking therapy utilizing a proprietary bio-activated pharmaceutical for the treatment of keratoconus, a rare corneal disorder. Glaukos continues to successfully develop and advance a robust pipeline of novel, dropless platform technologies designed to meaningfully advance the standard of care and improve outcomes for patients suffering from chronic eye 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 extent to which we may obtain regulatory approval for Epioxa or other investigational products, our ability to successfully commercialize such products, and the continued efficacy and safety profile of our products when commercially marketed as compared to their pre-approval clinical trial results. Historical, current and forward-looking sustainability-related statements may be based on standards for measuring progress that are still developing, internal controls and process that continue to evolve, and assumptions that are subject to change in the future. The information included in, and any issues identified as material for purposes of this document may not be considered material for SEC reporting purposes. In the context of this disclosure, the term “material” is distinct from, and should not be confused with, such term as defined for SEC reporting purposes. 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 Annual Report on Form 10-Q for the quarter ended September 30, 2024, which was filed with the Securities and Exchange Commission (SEC) on November 5, 2024. Our filings with the SEC are available in the Investor Section of our website at www.glaukos.com or at www.sec.gov . In addition, information about the risks and benefits of our products is available on our website at www.glaukos.com . All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on the forward-looking statements in this press release, which speak only as of the date hereof. We do not undertake any obligation to update, amend or clarify these forward-looking statements whether as a result of new information, future events or otherwise, except as may be required under applicable securities law.

Phase 3Clinical ResultNDADrug Approval

05 Jun 2023

·www.biospace.com

Glaukos Achieves Pipeline Milestone with Enrollment Completion in Phase 3 Confirmatory Trial for Epioxa (Epi-on)

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 . All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on the forward-looking statements in this press release, which speak only as of the date hereof. We do not undertake any obligation to update, amend or clarify these forward-looking statements whether as a result of new information, future events or otherwise, except as may be required under applicable securities law.

Phase 3NDAClinical Result

10 Jan 2023

·www.biospace.com

Glaukos Announces Positive Clinical Updates for Several Corneal Health Pipeline Programs

Commencement of Subject Enrollment in Epioxa™ Phase 3 Confirmatory Trial Promising Phase 2a Results for GLK-301 (iLution – Dry Eye Disease) Support Planned Phase 2b Study to Commence in 2023 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 positive clinical updates for several of its Corneal Health pipeline programs, including the commencement of subject enrollment in a second Phase 3 confirmatory trial for Epioxa™ (Epi-on™), and promising initial results from the company’s Phase 2a clinical trial for GLK-301 (iLution - Dry Eye Disease). “These clinical updates represent meaningful milestones for two of our key Corneal Health pipeline programs and we look forward to continuing to advance both of these important programs forward in 2023,” said Thomas Burns, Glaukos chairman and chief executive officer. “We continue to successfully invest in and advance our robust pipeline of novel, dropless platform technologies designed to meaningfully advance the standard of care and improve outcomes for patients suffering from chronic eye diseases.” Glaukos commenced subject enrollment in its second Phase 3 confirmatory pivotal trial for Epioxa (Epi-on), its next-generation corneal cross-linking therapy for the treatment of keratoconus. Glaukos plans to randomize approximately 290 subjects in this trial and is targeting enrollment completion by the end of 2023. As a reminder, the U.S. Food and Drug Administration (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 New Drug Application (NDA), in conjunction with this second 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. Glaukos also announced promising topline results from its Phase 2a first-in-human clinical trial for GLK-301 (iLution – Dry Eye Disease (DED)) for the signs and symptoms of DED. GLK-301 is a sterile ophthalmic topical cream to be applied to the eyelids for the treatment of signs and symptoms of DED. The trial’s endpoints included the evaluation of multiple signs and symptoms characteristic of DED. Topline Phase 2a outcomes for GLK-301 demonstrated improvement in the quality of tear film (tear break-up time) with corresponding improvement in quality of vision (reduction in blurred vision). Based on these encouraging observations, Glaukos plans to advance GLK-301 into a Phase 2b clinical trial targeted to begin in 2023. The Phase 2a multi-center, randomized, double-masked, placebo-controlled trial enrolled 218 subjects across clinical sites in the United States and was designed to evaluate the safety and efficacy of three different dose levels of GLK-301 administered twice daily (BID) to the eyelids versus placebo over 28 days, followed by a 14-day safety follow-up period, in subjects diagnosed with DED. GLK-301 is the first investigational drug candidate utilizing Glaukos’ iLution platform’s patented cream-based drug formulations that are applied to the outer surface of the eyelid for dropless transdermal delivery of pharmaceutically active compounds for the treatment of eye disorders. The cream formulation acts as a depot allowing pilocarpine to be delivered through the dermis of the eyelid to the eye. 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 or GLK-301, 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 September 30, 2022, which was filed with the Securities and Exchange Commission (SEC) on November 4, 2022. 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 . All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on the forward-looking statements in this press release, which speak only as of the date hereof. We do not undertake any obligation to update, amend or clarify these forward-looking statements whether as a result of new information, future events or otherwise, except as may be required under applicable securities law.

Clinical ResultPhase 2Phase 3NDA

100 Deals associated with Riboflavin 5'-Phosphate Sodium

External Link

KEGG	Wiki	ATC	Drug Bank
-	Riboflavin 5'-Phosphate Sodium	S01XA26	DB03247

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Corneal Diseases	US	Glaukos Corp.	15 Apr 2016
Keratoconus	US	Glaukos Corp.	15 Apr 2016
Riboflavin Deficiency	JP	TOA Eiyo Ltd.	20 Oct 1971

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Corneal Neovascularization	Discovery	US	Price Vision Group	15 Apr 2021

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ARVO2023	Not Applicable	-	-	Enhanced Riboflavin Stromal Delivery Using Microchannel-assisted Iontophoresis (Iontophoresis alone)	wibnwbjkxp(edppgbciux) = ethptjldwz wemzohzqpr (vymxopggjk )	-	23 Apr 2023
ARVO2023	Not Applicable	-	-	Enhanced Riboflavin Stromal Delivery Using Microchannel-assisted Iontophoresis (Iontophoresis with Microchannels)	wibnwbjkxp(edppgbciux) = cpujsfiifg wemzohzqpr (vymxopggjk )	-	23 Apr 2023
APAO2018	Not Applicable	Corneal ectasia	-	Riboflavin (OCT-guided femtosecond laser-assisted ICRS implantation)	vwmlshsols(uchisthfyi) = okgnwsiays xlqjfnnzdh (wydsexbxvu, 5.07)	-	08 Feb 2018
APAO2018	Not Applicable	Corneal ectasia	-	Corneal collagen crosslinking with intracorneal riboflavin injection	vwmlshsols(uchisthfyi) = agzrvasqrl xlqjfnnzdh (wydsexbxvu, 6.33)	-	08 Feb 2018
ARVO2016	Not Applicable	Corneal ectasia	129	riboflavin ultraviolet-A (Conventional corneal collagen cross-linking (CXL))	(lxkjbcdczq) = n=3 lgohsyfrvn (glvywrnikx ) View more	-	01 May 2016
Pubmed \| J Cataract Refract Surg	Not Applicable	Keratoconus	24	Corneal collagen crosslinking with riboflavin and ultraviolet-A light	elrgjqhdho(tlvuoucurk) = fymssujjxt xrkomqfbjt (mpmjulmvbc ) View more	-	01 Jan 2015
ARVO2013	Not Applicable	Corneal thinning	-	ISOSMOLAR RIBOFLAVIN (Control (no treatment))	qphqijlcia(jdpcyeadbt) = uechalwfuf ucodjsbctm (ounzgodetq )	-	01 Jun 2013
2D Flap-Extensiometry (ARVO2012)	Not Applicable	-	-	Corneal UV-Riboflavin Cross-linkingRiboflavinboflavin Cross-linking (UV-Riboflavin Cross-linking (CXL))	rcouszrccs(nohrqiqagl) = jsjljlwoqk apcglzdfon (yoiqirhnlo )	Positive	01 Mar 2012
2D Flap-Extensiometry (ARVO2012)	Not Applicable	-	-	Corneal UV-Riboflavin Cross-linking (Untreated corneas)	rcouszrccs(nohrqiqagl) = cktguswpbs apcglzdfon (yoiqirhnlo )	Positive	01 Mar 2012
Siena Eye Cross Study (Pubmed \| Am J Ophthalmol)	Phase 2	Keratoconus	363	Riboflavin Ultraviolet A Corneal Collagen Cross-linking	alcrahaifd(duablfhfey) = ybyfisotid qntltpcrkt (wcmhkombgs )	-	01 Apr 2010
ARVO2009	Not Applicable	-	-	5 minutes application of riboflavin	(pzehitvvno) = eykjpvoqxh kjybjxpsxh (bzldohoufd )	-	01 Apr 2009
ARVO2009	Not Applicable	-	-	10 minutes application of riboflavin	(pzehitvvno) = hgpfzsuryu kjybjxpsxh (bzldohoufd )	-	01 Apr 2009
NCT05516004 \| NCT00841386 \| NCT01325298 (Pubmed \| J Cataract Refract Surg)	Phase 2/3	Keratoconus	10	Riboflavin-ultraviolet type A rays induced cross-linking of corneal collagen	tficrpiohr(zbbygrhvrp) = bpnbblzwqo bcdgztzoea (lfywfayzyr ) View more	-	01 May 2006

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Understand key drug designations in just a few clicks with Synapse.

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Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis