The objective of this study is to evaluate the safety and image quality of the investigational dye, MB-102, compared to the control dye (fluorescein sodium) in healthy and diseased eyes using fluorescent angiography for retinal vascular disease diagnosis and monitoring.

Start Date01 Dec 2024

Sponsor / Collaborator

MediBeacon, Inc.

NCT06054178 / Enrolling by invitationPhase 2IIT

Intraoperative Nerve Identification With Fluorescein Sodium

The purpose of this study is to see if there is benefit in using an IV contrast (sodium fluorescein) to identify nerves during head and neck surgery.

Start Date07 Nov 2024

Sponsor / Collaborator

Stanford University

NCT05664555 / CompletedPhase 4IIT

Low Dose Fluorescein Angiography Comparing 1mL and 3mL of 10% Fluorescein: A Randomized Controlled Trial

This study aims to compare the efficacy and safety of fluorescein angiography using 1mL versus 3mL of 10% fluorescein dye.

Start Date01 Feb 2023

Sponsor / Collaborator

Seoul National University Bundang Hospital

100 Clinical Results associated with Fluorescein Sodium

100 Translational Medicine associated with Fluorescein Sodium

100 Patents (Medical) associated with Fluorescein Sodium

1,160

Literatures (Medical) associated with Fluorescein Sodium

01 Jan 2025·METHODS

Optimizing Retinal Imaging: Evaluation of ultrasmall TiO2 nanoparticle- fluorescein conjugates for improved Fundus Fluorescein Angiography

Article

Author: Ligorio Fialho, Sílvia ; Ligório Fialho, Sílvia ; Amaral de Melo, Lutiana ; Araki, Koiti ; Ken Kawassaki, Rodrigo ; França Dias, Marina ; Raphael Guimarães, Robson

Fundus Fluorescein Angiography (FFA) has been extensively used for the identification, management, and diagnosis of various retinal and choroidal diseases, such as age-related macular degeneration, diabetic retinopathy, retinopathy of prematurity, among others. This exam enables clinicians to evaluate retinal morphology and the pathophysiology of retinal vasculature. However, adverse events, including from mild to severe reactions to sodium fluorescein, have been reported. Titanium dioxide nanoparticles (NPTiO₂) have shown significant potential in numerous biological applications. Coating or conjugating these nanoparticles with small molecules can enhance their stability, photochemical properties, and biocompatibility, as well as increase the hydrophilicity of the nanoparticles, making them more suitable for biomedical applications. This work demonstrates the potential use of ultrasmall titanium dioxide nanoparticles conjugated with sodium fluorescein to improve the quality of angiography exams. The strategy of conjugating fluorescein with NPTiO₂ successfully enhanced the fluorescence photostability of the contrast agent and increased its retention time in the retina. Preliminary in vivo and in vitro safety tests suggest that these nanoparticles are safe for the intended application demonstrating low tendency to hemolysis, and no significant changes in the retina thickness or in the electroretinography a-wave and b-wave amplitudes. Overall, the conjugation of fluorescein to NPTiO₂ has produced a nanomaterial with favorable properties for use as an innovative contrast agent in FFA examinations. By providing a clear description of our methodology of analysis, we also aim to offer better perspectives and reproducible conditions for future research.

01 Dec 2024·VETERINARY JOURNAL

Real-time in vivo confocal laser endomicroscopic imaging of equine endometrium: Preliminary observations and feasibility study

Article

Author: Len, J ; Woolford, L ; Kind, K L ; Gilbert, R O ; Santos, L C ; Serpa, P B S ; Gallacher, K

Endometrial health is vital for the reproductive efficiency of broodmares and accurate diagnostic testing is crucial for directing the best treatment options and outcomes. Confocal laser endomicroscopy (CLE) is an endoscopic technique for obtaining in-vivo, real-time microscopic imaging of tissues using a fiber optic probe. CLE relies on induced tissue fluorescence and fluorescein sodium, given intravenously, is the contrast agent most used in human medicine. This study aimed to determine the feasibility of CLE for imaging equine endometrium and determine a standard dose of fluorescein sodium to achieve optimal cellular imaging. In-vivo CLE was performed on 44 mares, and the images were compared with routine histopathological analysis of endometrial biopsies. No adverse reactions occurred after IV fluorescein sodium administration and a dose of 4 mg/kg was established (0.04 mL/kg of 10 % fluorescein sodium solution) to achieve optimal image contrast. CLE enabled multiple regions of the endometrium to be assessed quickly. Distinct tissue architecture patterns could be appreciated using CLE, and the luminal epithelium could be assessed for integrity (ulceration) and exocytosed inflammatory cells. Endometrial gland distribution, density, shape, and epithelial height were evaluated. Blood vessels were clearly outlined, and inflammatory cells and fibrosis were discernable within the interstitium. Image quality varied between mares, and the stage of oestrous cycle may have been a factor of influence. This novel imaging modality enables collection of "virtual" biopsies and facilitates critical assessment of multiple regions of the uterus compared with the standard histopathologic assessment of a single random tissue biopsy.

01 Dec 2024·Indian Journal of Surgical Oncology

Combined Fluorescein and Methylene Blue Dye for Sentinel Lymph Node Biopsy in Patients of Early Carcinoma Breast: A Promising Technique

Article

Author: Hussaini, Syed Shujatulla ; Sethi, Rajandeep Singh ; Patni, Sanjeev ; Kaur, Navjot ; Sharma, Anjali ; Sharma, Prashant

Sentinel lymph node biopsy is currently the gold standard for clinically node-negative patients of carcinoma breast. Fluorescein is a safe, low-cost agent, and easily available. Fluorescein has shown a promising role in sentinel lymph node evaluation in carcinoma breast in combination with methylene blue dye with a detection rate of more than 90% and a false-negative rate of less than 10% in previous studies. This study aims to determine the detection rate and diagnostic accuracy of fluorescein and methylene blue dye in early breast cancer. The identification rate and false-negative rate of the combined blue and fluorescent dye method were 100% and 7.14% respectively. The accuracy of the combined blue and fluorescein dye method was 98.3%. The sensitivity, specificity, negative predictive value, and positive predictive value of the combined blue dye and fluorescein dye method were 92.8%, 100%, 97.8%, and 100% respectively. Thus, the combined blue and fluorescein dye method is an easy, safe, cost-effective, and reliable method of sentinel lymph node biopsy in early breast cancer patients.

News (Medical) associated with Fluorescein Sodium

12 Aug 2024

·www.prnewswire.com

OcuMension acquires rights to Alcon eye drops in exchange for a 16.7% equity stake, signaling the commencement of comprehensive strategic relationship

SHANGHAI, Aug. 12, 2024 /PRNewswire/ -- On August 13th 2024, Ocumension Therapeutics (" OcuMension") announced an agreement with Alcon Inc. (" Alcon", and collectively with OcuMension, the " Parties") where OcuMension will acquire or secure commercialization rights in China to a portfolio of Alcon dry eye treatments and procedural drops, including several commercially available products and one development-stage product. The scope of the agreement will also cover areas of R&D, manufacturing and commercialization in China. In connection with the transfer of these rights, OcuMension will issue 139,161,120 shares to Alcon, accounting for 16.71% of the total share capital (post-issuance). Consequently, Alcon becomes one of the largest shareholders of OcuMension. Under the terms of the arrangement, each company has granted the other company a right of first negotiation over future products. OcuMension, as a leading Chinese ophthalmic pharmaceutical platform company, focuses on integrating comprehensive capabilities across the entire lifecycle of ophthalmic drug development—from research and development to commercialization. OcuMension possesses a portfolio of 25 pharmaceutical assets. Alcon, the global leader in eye care, offers a broad portfolio of products to enhance sight and improve lives for patients in more than 140 countries. Under this arrangement, OcuMension will acquire outright, Tears Natural® Forte, Bion Tears, Alcaine®, Fluorescite, and Cyclogyl, in the Chinese market and the commercialization rights in China to Systane® Ultra and AR-15512, a novel topical drug candidate for dry eye. Under the terms of this agreement, OcuMension will manufacture those products acquired outright for China after a transition period. OcuMension will also develop, manufacture and commercialize AR-15512 in China. The addition of these seven mature products and AR-15512 to OcuMension's portfolio is expected to further enhance OcuMension's leadership in the ophthalmology field in the China market. Through the acquisition of these products, OcuMension expects to be capable of providing more comprehensive and advanced treatment solutions, further meeting patient needs and expanding market share. The Parties expect that the framework of this agreement will allow both Parties to further promote technological advancements and innovations in the field of ophthalmology. Ophthalmic diseases are internationally recognized as one of the highly focused medical sub-sectors, with innovative treatment solutions for ophthalmology still awaiting development. Based on this, OcuMension will continue to focus on bringing safer, more efficient, and cutting-edge treatment solutions to global ophthalmic patients, meeting the growing medical needs of patients. About Alcon Alcon helps people see brilliantly. As the global leader in eye care with a heritage spanning over 75 years, Alcon offers the broadest portfolio of products to enhance sight and improve people's lives. Alcon's Surgical and Vision Care products touch the lives of more than 260 million people in over 140 countries each year living with conditions like cataracts, glaucoma, retinal diseases and refractive errors. Alcon's more than 25,000 associates are enhancing the quality of life through innovative products, partnerships with Eye Care Professionals and programs that advance access to quality eye care. Learn more at . About OcuMension OcuMension is a China-based ophthalmic pharmaceutical platform company dedicated to identifying, developing and commercializing first- or best-in-class ophthalmic therapies. OcuMension's vision is to provide a world-class pharmaceutical total solution to address significant unmet ophthalmic medical needs in China. Since its inception, OcuMension has focused on building a platform integrating specialized capabilities in each major functionality involved in an ophthalmic drug's development cycle, from research and development, manufacturing to commercialization. OcuMension believes its platform positions it well to achieve leadership in China ophthalmology, with a first-mover advantage over future competitors. Advisors Morrison Foerster acted as legal advisor to OcuMension in this transaction. Lazard acted as financial advisor to Alcon and Gibson Dunn as its legal advisor. SOURCE OcuMension

AcquisitionLicense out/in

03 Mar 2023

·www.biospace.com

Clinical Study Demonstrates Bentrio's Superior Nasal Residence Time and Rheological Properties

Bentrio® remained detectable by fluorescence for up to 210 minutes in subjects' nasal passages vs. 60 minutes with saline nasal spray control Long nasal residence time supports extended protective effects against airborne allergens and other potentially harmful particles HAMILTON, BERMUDA / ACCESSWIRE / March 3, 2023 / Altamira Therapeutics Ltd. (NASDAQ:CYTO), a company dedicated to developing therapeutics that address important unmet medical needs, today reported that data from a recent peer-reviewed clinical study involving Bentrio nasal spray's residence time and other rheological properties demonstrated superiority vs. a saline control. The study results are published in Drug Development and Industrial Pharmacy (Taylor & Francis) and its full text is publicly available at: Study excerpts: "The data presented in this study indicate that AM-301 (Bentrio) has a prolonged nasal residence time of up to 3.5 h compared to a saline control. AM-301 is a safe and well-tolerable medical device with features suitable for intranasal administration. Its nasal residence time and distribution encourage its use to protect nasopharyngeal areas. Two nasal spray applications per nostril provide no substantial benefit over a single spray with regards to coverage of the mucosal surface or nasal retention time." "Importantly, the formulation also reached the oropharynx, remaining in place for up to 240 min compared with 60 min in the control group. This feature is particularly important, since airborne viruses and allergens come into contact with both the nasal mucosa and oropharyngeal cavity." Study Highlights The study was performed on eight healthy volunteers that were administered Bentrio or a classic saline nasal spray marked with a fluorescent agent (fluoresceine 0.1%) to track the distribution within the nasal cavity and the nasal residence time for up to 240 minutes. Participants were administered a single dose or, in case of Bentrio, also a repeated dose at a different spray angle. Bentrio was found to be widely distributed in the lower to middle parts of the nasal cavity (in particular inferior turbinate and septum, to a lesser extent also on the middle turbinate), which is where airborne allergen particles typically collect. The thin protective film was present for 210 minutes. There were no meaningful differences between single and repeated dose application of Bentrio, confirming that one puff is sufficient. In contrast, saline nasal spray showed a shorter nasal residence time of 60 minutes only. Bentrio's extended presence within the nasal cavity is achieved thanks to its special thixotropic properties: the formulation is a gel designed to adhere to the nasal mucosa for an extended time, whereas a saline solution is prone to rapid run-off. Bentrio's gel formulation becomes sprayable upon shaking it briefly prior to application. Bentrio's long nasal residence time is supporting the extended protective effect of the nasal spray as it could be observed in other studies, including grass pollen and house dust mite challenge studies. Images In the single dose saline spray control group, fluorescence disappeared within 60 minutes from the nose, whereas the groups using a single dose of Bentrio retained a detectable amount of fluorescence for up to 210 minutes on the middle and inferior turbinates. As shown in Figure 1- Anterior Rhinoscopy below, images were taken at different time points to track the amount of fluorescence still visible after a single application of Bentrio or saline nasal spray. Figure 1 While nasal residence time was the main focus of the study, the presence of the fluorescence in the oropharynx was monitored for 240 minutes as well. The image below, Figure 2- Oropharyngeal Endoscopy, shows that fluorescence for all three groups started to appear in the throat five to ten minutes after administration. The finding that Bentrio does not slow down discharge from the nasal cavity to the throat, suggests that the protective film established by Bentrio within the nasal cavity does not interfere with mucociliary clearance, a normal, physiological process that helps the body to clear particles out of the nose for discharge via the digestive tract. The saline control group's fluorescence disappeared after 90-120 minutes versus the Bentrio groups which showed fluorescence for up to 240 minutes. Figure 2 The results of the study show that the rheological properties of the AM-301 formulation allow it to be sprayed once and effectively provide extended coverage and protection of the nasal mucosa without interfering with natural nasal clearance. The study was conducted and examinations performed at the Department of Otorhinolaryngology, Head and Neck Surgery of the University Medical Center of the Eberhard-Karls University Tübingen, Germany. About Drug Development and Industrial Pharmacy The aim of Drug Development and Industrial Pharmacy is to publish novel, original, peer-reviewed research and review manuscripts related to pharmaceutical science research, specifically in the fields of nanomedicines, formulation, development and delivery technologies, biopharmaceuticals, new material development and processing technology advancement. Research papers must be hypothesis driven and emphasize innovative breakthrough topics. Timely critical review papers within the journal scope are also welcomed. About Altamira Therapeutics Altamira Therapeutics (Nasdaq:CYTO) is dedicated to developing RNA-based therapeutics for extrahepatic targets (OligoPhore™ / SemaPhore™ delivery platforms). The Company currently has two flagship siRNA programs in preclinical development beyond in vivo proof of concept: AM-401 for KRAS driven cancer and AM-411 for rheumatoid arthritis. The versatile delivery platform is also suited for mRNA and other types of RNA therapeutics and shall be leveraged via out-licensing to pharma or biotech companies. In addition, Altamira is in the process of divesting and/or licensing-out its legacy assets in allergology and viral infection (Bentrio® OTC nasal spray; commercial) and inner ear therapeutics (AM-125 nasal spray for vertigo; post Phase 2; Keyzilen® and Sonsuvi® for tinnitus and hearing loss; Phase 3). Founded in 2003, Altamira is headquartered in Hamilton, Bermuda, with its main operations in Basel, Switzerland. For more information, visit: Forward-Looking Statements This press release may contain statements that constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are statements other than historical facts and may include statements that address future operating, financial or business performance or Altamira Therapeutics' strategies or expectations. In some cases, you can identify these statements by forward-looking words such as "may", "might", "will", "should", "expects", "plans", "anticipates", "believes", "estimates", "predicts", "projects", "potential", "outlook" or "continue", or the negative of these terms or other comparable terminology. Forward-looking statements are based on management's current expectations and beliefs and involve significant risks and uncertainties that could cause actual results, developments and business decisions to differ materially from those contemplated by these statements. These risks and uncertainties include, but are not limited to, the success of the continued commercialization of Bentrio and success of strategic transactions, including licensing or partnering, with respect to Bentrio or any other legacy assets, Altamira Therapeutics' need for and ability to raise substantial additional funding to continue the development of its product candidates, the timing and conduct of clinical trials of Altamira Therapeutics' product candidates, the clinical utility of Altamira Therapeutics' product candidates, the timing or likelihood of regulatory filings and approvals, Altamira Therapeutics' intellectual property position and Altamira Therapeutics' financial position, including the impact of any future acquisitions, dispositions, partnerships, license transactions or changes to Altamira Therapeutics' capital structure, including future securities offerings. These risks and uncertainties also include, but are not limited to, those described under the caption "Risk Factors" in Altamira Therapeutics' Annual Report on Form 20-F for the year ended December 31, 2021, and in Altamira Therapeutics' other filings with the SEC, which are available free of charge on the Securities Exchange Commission's website at: . Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those indicated. All forward-looking statements and all subsequent written and oral forward-looking statements attributable to Altamira Therapeutics or to persons acting on behalf of Altamira Therapeutics are expressly qualified in their entirety by reference to these risks and uncertainties. You should not place undue reliance on forward-looking statements. Forward-looking statements speak only as of the date they are made, and Altamira Therapeutics does not undertake any obligation to update them in light of new information, future developments or otherwise, except as may be required under applicable law. CONTACT Hear@altamiratherapeutics.com 800-460-0183 SOURCE: Altamira Therapeutics Ltd. View source version on accesswire.com:

Clinical ResultPhase 2Phase 3

100 Deals associated with Fluorescein Sodium

External Link

KEGG	Wiki	ATC	Drug Bank
D02024	Fluorescein Sodium	S01JA01	DB00693

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Contrast agents	US	Alcon Laboratories, Inc.	28 Mar 2006
Diagnostic agents	US	Novartis Pharmaceuticals Corp.	10 Nov 1976
Optic Nerve Diseases	JP	Novartis Pharma KK	29 Sep 1976
Retinal Diseases	JP	Novartis Pharma KK	29 Sep 1976
Uveal Diseases	JP	Novartis Pharma KK	29 Sep 1976

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Breast Cancer	Phase 2	US	Vestan Ltd.	01 Jun 2014
Node-positive breast cancer	Phase 2	US	Vestan Ltd.	01 Jun 2014

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03752203 (CTgov)	Not Applicable	-	2	Microscopic Resection+Sodium Fluorescein	jstjqxahgr(lzetirdahl) = rouqruawbv usfukjwlyj (dbydakaiyc, cjfiuqcyoi - wkhntismwb) View more	-	14 Feb 2024
NCT04351373 (CTgov)	Phase 2	Acoustic Neuroma \| Paraganglioma \| Meningioma	12	YELLOW560 filter+Fluorescein Sodium	xlbkorbeha(kyehensmqe) = mjkmafwpet dopzhbcjok (pvgwkoutqn, ljlotxszhf - pkdddzqlao) View more	-	01 Aug 2023
NCT03189134 (CTgov)	Phase 1	Heart Septal Defects, Atrial	6	Cellvizio 100 Series System+Fluorescite	pvjyoicqzm(sknjsmdiqq) = poeptjgbld ibbrvpomgv (gzmbivjsel, jsdgqjlirt - zxnkeblyrv) View more	-	07 Jul 2020
NCT02476448 (JET, CTgov)	Not Applicable	Ureteral Diseases	176	normal saline (Normal Saline)	ansaudzpqy(ciwchktonj) = zplblozimb pjjqydliof (vfgwvnylhb, dlazpbaezx - oirnxrfnei) View more	-	23 Oct 2019
NCT02476448 (JET, CTgov)	Not Applicable	Ureteral Diseases	176	Dextrose 10% (Dextrose 10%)	ansaudzpqy(ciwchktonj) = psuzceuagb pjjqydliof (vfgwvnylhb, qeletyomiy - xyueswklfk) View more	-	23 Oct 2019
ARVO Annual Meeting 2019 (ARVO2019)	Not Applicable	Dry Eye Syndromes	-	fluorescein breakup time test (Dry Eye Test (DET))	xiroaddvmv(mfqipphdby) = flnebtvxrt xgcwggrtsi (iezacognkb )	Positive	01 Jul 2019
ARVO Annual Meeting 2019 (ARVO2019)	Not Applicable	Dry Eye Syndromes	-	fluorescein breakup time test (Standard Strip (SS))	xiroaddvmv(mfqipphdby) = oafetyaqbr xgcwggrtsi (iezacognkb )	Positive	01 Jul 2019
NCT02677623 (CTgov)	Phase 4	Ureteral Obstruction	140	Pyridium (A- Pyridium)	ddnmeddukk(pfrojubbyl) = ezakpjovhg xpfyhvbqhi (rjbcgeqash, vhmblfenvu - vkcjjisiyr) View more	-	30 May 2019
NCT02677623 (CTgov)	Phase 4	Ureteral Obstruction	140	Sodium Fluorescein (B- Sodium Fluorescein)	ddnmeddukk(pfrojubbyl) = zxrmzsuyno xpfyhvbqhi (rjbcgeqash, cuunuwynfp - yucxygoiws) View more	-	30 May 2019
NCT01886235 (CTgov)	Not Applicable	Melanoma, Cutaneous Malignant \| Melanoma recurrent	10	Diagnostic Microscopy+Fluorescein Sodium Injection	lebwfwibdg(bqnvludlpd) = qvxbqhzjlo dmfjjonvkq (llqfxsuaqb, gvptlfqavz - ychteotjmd) View more	-	06 Jun 2017
NCT02028325 (Fluorescein, CTgov)	Phase 4	Cerebrovascular Disorders \| Brain Cancer	136	Fluorescein Sodium	lgtrylrqzc(vhrlzgnvuz) = mmnwgmxiru esnrjyblzb (geqvzspkzr, lhjhvxepjz - qwltjebleg) View more	-	29 Sep 2016

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