RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-MASKED STUDY OF THE SAFETY AND EFFICACY OF POS (0.75% PHENTOLAMINE OPHTHALMIC SOLUTION) IN PARTICIPANTS WITH PREVIOUS KERATOREFRACTIVE SURGERY WITH DECREASED VISUAL ACUITY UNDER MESOPIC CONDITIONS

The goal of this clinical trial is to learn if Phentolamine Ophthalmic Solution works to treat adults that have had keratorefractive surgery and have decreased visual acuity under mesopic conditions. It will also learn about the safety of Phentolamine Ophthalmic Solution. The main questions it aims to answer are:
Researchers will compare Phentolamine Ophthalmic Solution to a placebo (a look-alike substance that contains no drug) to see if Phentolamine Ophthalmic Solution works to improve vision in low light conditions.
Participants will:
Take Phentolamine Ophthalmic Solution or a placebo drop every day for 2 weeks Visit the clinic once every week for 2 weeks for checkups and tests Keep a diary of when they instill the study medication each evening

Start Date02 Sep 2025

Sponsor / Collaborator

Opus Genetics, Inc.

NCT05448807

/ RecruitingPhase 3IIT

A Randomized Effectiveness of Phentolamine Mesylate as a Reversing Agent for Local Anesthesia in Decreasing Self- Inflicted Soft Tissue Trauma Following Local Anaesthesia Injection for Dental Procedure in Children: Randomized Clinical Trial

Local anaesthesia is considered one of the most alarming and non-comfortable dental procedures for children. This goes back to the persisting effect of the local anaesthesia after finishing dental procedures. The effect of Local anaesthesia can last from 3 to 5 hours due to the presence of vasoconstrictor. The U.S Food and Drug Administration (FDA approved the use of phentolamine mesylate (Oraverse) in May 2008 to be used as a drug in reversing the numbing effect of Local anaesthesia by decreasing the time needed to restore the normal functions of the mouth

Start Date05 Jul 2025

Sponsor / Collaborator

Cairo University

NCT07012512

/ Not yet recruitingNot ApplicableIIT

Adjusted Study Protocol: Within-Subject Paired-Eye Design Comparing Pilocarpine 0.1%, Phentolamine 0.75%, and Combination Therapy for Cyclopentolate Reversal in Children

The study aims at reversing pupillary dilatation. and cycloplegia in children undergoing cycloplegic refraction for eyeglasses prescription and ocular examination. This will be achieved using pilocarpine , phentolamine or a combination. This may help decrease the glare and improve near vision early to decrease unwanted effects of cycloplegic drops.

Start Date01 Jun 2025

Sponsor / Collaborator

Mansoura University

100 Clinical Results associated with Phentolamine Mesylate

100 Translational Medicine associated with Phentolamine Mesylate

100 Patents (Medical) associated with Phentolamine Mesylate

12,091

Literatures (Medical) associated with Phentolamine Mesylate

01 Nov 2025·POULTRY SCIENCE

Effects of pectic oligosaccharide on growth performance, organ indexes and intestinal health in broilers exposed to aflatoxin B1

Article

Author: Ye, Hui ; Zhang, Changming ; Wang, Weiwei ; Zuo, Jianjun ; Qin, Yongzhi ; Dong, Zemin ; Ye, Zhengqi ; Zhang, Haijun ; Cao, Qingyun ; Xian, Meitian

This study aimed at investigating the influences of pectic oligosaccharide (POS) on growth performance, organ indexes and intestinal health in broilers exposed to aflatoxin B₁ (AFB₁). In vitro experiment was conducted to assess reactive oxygen species (ROS)-scavenging ability of POS. In vivo experiment was then implemented by allocating 320 one-day-old yellow-feathered broilers to 4 groups (8 replicates/group), according to a 2 × 2 factorial arrangement with POS addition (0 or 400 mg/kg) and AFB₁ exposure (with or without) as the two factors. All parameters were determined on d 21. The results revealed an in vitro ability of POS to scavenge ROS. AFB₁ exposure tended to decrease (P < 0.10) average daily gain (ADG) and average daily feed intake (ADFI), as well as caused abnormities in liver, thymus and bursal indexes. It also elevated (P < 0.05) intestinal ROS and malondialdehyde contents but reduced (P < 0.05) intestinal catalase and glutathione peroxidase activities, as well as caused intestinal injuries including the decreasing trends (P < 0.10) of ileal villus height:crypt depth ratio and the relative mRNA expression of claudin-1 together with the increasing trend (P < 0.10) of serum diamine oxidase (DAO) activity. POS addition tended to elevate (P < 0.10) ADG and ADFI, as well as mitigated AFB₁-induced elevation (P < 0.10) in spleen index and reduction (P < 0.05) of bursal index. Moreover, POS addition tended to enhance (P < 0.10) ileal total antioxidant capacity in AFB₁-exposed broilers. Besides, POS addition lowered (P < 0.05) ROS level and increased (P < 0.05) glutathione content in ileum, as well as showed a tendency (P < 0.10) to elevate ileal claudin-1 expression and decrease serum DAO activity of broilers regardless of AFB₁ exposure. Collectively, supplemental POS benefited growth performance and organ indexes of broilers exposed to AFB₁, which could attribute to its ability to ameliorate intestinal redox state and integrity. These findings underscore a potential of POS to attenuate the detriments of AFB₁ contamination in diets.

02 Sep 2025·PEST MANAGEMENT SCIENCE

Biogenic amines modulate cannibalistic behaviors in the fall armyworm, Spodoptera frugiperda.

Article

Author: Qi, Yi-Xiang ; Zhou, Chuan-Zhi ; Li, Zi-Yuan ; Lu, Yong-Yue

BACKGROUND:

Cannibalism, defined as the ingestion of an individual by another individual from the same species, is a phenomenon prevalent across various animal groups, particularly among the larvae of the fall armyworm, Spodoptera frugiperda. These larvae exhibit cannibalistic tendencies under specific environmental conditions.

RESULTS:

This study demonstrates that cannibalism is rarely observed during the first- and second-instar stages in S. frugiperda. The highest proportion of cannibalism was recorded among fifth- and sixth-instar larvae, with a clear increasing trend observed from the fourth- to fifth-instar stages. Starvation and high-density rearing conditions are some factors that significantly enhance the frequency of cannibalism. Among the biogenic amines tested, only octopamine and the expression of its rate-limiting enzyme gene TβH were significantly elevated under starvation and crowded conditions. Furthermore, treatment with octopamine, a neuroactive compound, substantially increased the frequency of cannibalistic attacks in the fifth-instar larvae. Conversely, supplementation with phentolamine, an octopamine receptor antagonist, effectively suppressed starvation-induced cannibalism.

CONCLUSION:

These findings indicate that octopamine is a critical mediator of cannibalistic behavior in S. frugiperda. This insight may offer a foundation for developing novel pest control strategies targeting behavioral modulation in S. frugiperda. © 2025 Society of Chemical Industry.

01 Sep 2025·Journal of Infusion Nursing

Nursing Care in the Management of Injuries Due to Vasoactive Drug Extravasation: Scoping Review

Article

Author: de Oliveira E Araújo, Rhayssa ; Bispo, Monise de Melo ; Sena, Bárbara de Oliveira ; Barros Ribeiro, Katia Regina ; de Lima, Camila Almeida ; das Chagas, Ana Larysa Galdino

Objective: The aim of this study was to map nursing care in the treatment of lesions due to vasoactive drug extravasation. This scoping review is built according to the recommendations of the Joanna Briggs Institute and PRISMA-ScR. Methods: The review was carried out from July to August 2022, across 12 data sources. The evidence was evaluated using PAGER. Results: Initially, 2124 studies were found. After screening and complete analysis, 12 were left, which were used for a reverse search in the literature, which resulted in 20 studies, for a total of 32 studies. The main types of care found included interruption of vasoactive drug infusion, drainage of the extravasated solution, removal of the catheter, hot or cold compresses, elevation of the limb, phentolamine, topical nitroglycerin 2%, infusion of hyaluronidase, flush-out or salt washing technique, and autolytic debridement. Conclusion: The interventions demonstrated repetitions in several studies, low variety in treatment, and low methodological rigor.

157

News (Medical) associated with Phentolamine Mesylate

04 Sep 2025

·www.globenewswire.com

Opus Genetics Doses First Patient in Pivotal LYNX-3 Phase 3 Trial Evaluating Phentolamine Ophthalmic Solution 0.75% in Keratorefractive Patients With Visual Disturbances Under Mesopic, Low-Contrast Conditions

RESEARCH TRIANGLE PARK, N.C., Sept. 04, 2025 (GLOBE NEWSWIRE) -- Opus Genetics, Inc. (Nasdaq: IRD), a clinical-stage biopharmaceutical company developing gene therapies for inherited retinal diseases (IRDs) and small-molecule therapies for other ophthalmic disorders, today announced that the first patient has been dosed in LYNX-3, the Company’s pivotal Phase 3 clinical trial evaluating Phentolamine Ophthalmic Solution 0.75% in treating significant, chronic night driving impairment in keratorefractive patients with reduced mesopic vision. LYNX-3 is the second Phase 3 trial for this indication with Fast Track designation from the U.S. Food and Drug Administration (FDA) and is being conducted under a Special Protocol Assessment (SPA). Positive topline results from the first Phase 3 trial, LYNX-2, were announced in June 2025. Night-vision disturbances, which can include glare, halos, and starbursts, are common in some patients after keratorefractive procedures such as LASIK and currently have no FDA-approved treatment options. Phentolamine Ophthalmic Solution 0.75%, a non-selective α1/α2 adrenergic antagonist, is designed to moderately reduce pupil size in low-light conditions to potentially decrease the impact of aberrant peripheral light rays entering the pupil while maintaining retinal contrast sensitivity. “Dosing the first patient in LYNX-3 is a significant milestone for our Phentolamine program, which already has one approved indication for the reversal of drug-induced mydriasis, positive Phase 3 data in potentially treating presbyopia, and now an ongoing Phase 3 trial for keratorefractive patients with visual disturbances under mesopic, low-contrast conditions,” said George Magrath, M.D., Chief Executive Officer, Opus Genetics. “These positive Phase 3 data represent the opportunity to address a critical need for millions of patients affected by these symptoms.” “Even after otherwise successful refractive surgery, such as LASIK, some patients can experience visual quality challenges in low-light conditions,” said Jay Pepose, M.D., Ph.D., Chief Medical Advisor, Opus Genetics. “Following the positive results from LYNX-2, the LYNX-3 study is the second pivotal Phase 3 study designed to further evaluate whether Phentolamine Ophthalmic Solution 0.75% can meaningfully improve functional dim light vision and reduce patient-reported glare, starburst and halos, which could represent a significant advance in post-refractive surgical care.” About LYNX-3 LYNX-3 is a multicenter, randomized, double-masked, placebo-controlled Phase 3 trial that will enroll approximately 200 adults with documented decreased visual acuity in mesopic (low-light) conditions following keratorefractive surgery, including Laser-Assisted In Situ Keratomileusis (LASIK), Photorefractive Keratectomy (PRK), Small-Incision Lenticule Extraction (SMILE), Radial Keratotomy (RK). Participants will be randomized 1:1 to receive once-daily evening dosing of Phentolamine Ophthalmic Solution 0.75% or placebo for approximately two weeks. LYNX-3 is the second of two, pivotal Phase 3 studies and follows the same study design and patient population as the first study, LYNX-2. The primary endpoint is the percentage of participants achieving a ≥15-letter Early Treatment Diabetic Retinopathy Study (ETDRS) (≥3-line) improvement from baseline in mesopic low-contrast visual acuity (mLCVA) in the study eye at Day 15. Key secondary endpoints include patient-reported outcomes related to night driving, glare, halos, and starbursts, as well as binocular visual function measures. Safety assessments will include ocular and systemic evaluations. About Phentolamine Ophthalmic Solution 0.75% Phentolamine Ophthalmic Solution 0.75% is a relatively non-selective alpha-1 and alpha-2 adrenergic antagonist to reduce pupil size, administered as an eye drop. It works by blocking the alpha-1 receptors found on the radial iris dilator muscles, which are activated by the alpha-1 adrenergic receptors. Phentolamine Ophthalmic Solution 0.75% is designed to reduce pupil diameter through a sympatholytic mechanism of action that avoids engaging the ciliary muscle, potentially reducing risks such as retinal tears or detachment associated with older parasympathomimetic agents. Phentolamine Ophthalmic Solution 0.75% has successfully completed a Phase 3 program for presbyopia (VEGA clinical program) and is being evaluated in a Phase 3 program for the treatment of dim (mesopic) light vision disturbances (sometimes referred to as DLD) after keratorefractive surgery (LYNX clinical program). The U.S. FDA granted Fast Track designation to Phentolamine Ophthalmic Solution 0.75% for the treatment of significant, chronic night driving impairment with concomitant increased risk of motor vehicle accidents and debilitating loss of best spectacle corrected mesopic vision in keratorefractive patients with photic phenomena (i.e., glare, halos, starburst). About Opus Genetics Opus Genetics is a clinical-stage biopharmaceutical company developing gene therapies for the treatment of inherited retinal diseases (IRDs) and small molecule therapies for other ophthalmic disorders. The Company’s pipeline features AAV-based gene therapies targeting inherited retinal diseases including Leber congenital amaurosis (LCA), bestrophinopathy, and retinitis pigmentosa. Its lead gene therapy candidates are OPGx-LCA5, which is in an ongoing Phase 1/2 trial for LCA5-related mutations, and OPGx-BEST1, a gene therapy targeting BEST1-related retinal degeneration. Opus Genetics is also advancing Phentolamine Ophthalmic Solution 0.75%, a partnered therapy currently approved in one indication and being studied in two Phase 3 programs for presbyopia and reduced low light vision and nighttime visual disturbances. The Company is based in Research Triangle Park, NC. For more information, visit www.opusgtx.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, expectations regarding us, our business prospects and our results of operations and are subject to certain risks and uncertainties posed by many factors and events that could cause our actual business, prospects and results of operations to differ materially from those anticipated by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those described under the heading “Risk Factors” included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2025 and June 30, 2025, and our other filings with the U.S. Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. These forward-looking statements are based upon our current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties. In some cases, you can identify forward-looking statements by the following words: “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “aim,” “may,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. We undertake no obligation to revise any forward-looking statements in order to reflect events or circumstances that might subsequently arise. Contacts: InvestorsJenny KobinRemy BernardaIR Advisory Solutionsir@opusgtx.com MediaKimberly HaKKH Advisors917-291-5744kimberly.ha@kkhadvisors.com Source: Opus Genetics, Inc.

Phase 3Fast TrackGene Therapy

03 Sep 2025

·www.globenewswire.com

Opus Genetics to Participate in the H.C. Wainwright 27th Annual Global Investment Conference

RESEARCH TRIANGLE PARK, N.C., Sept. 03, 2025 (GLOBE NEWSWIRE) -- Opus Genetics, Inc. (Nasdaq: IRD) (the “Company” or “Opus Genetics”), a clinical-stage biopharmaceutical company developing gene therapies for the treatment of inherited retinal diseases (IRDs) and small molecule therapies for other ophthalmic disorders, announced today that George Magrath, MD, Chief Executive Officer, and Ash Jayagopal, Ph.D., MBA, Chief Scientific and Development Officer, will deliver a corporate update at the H.C. Wainwright 27th Annual Global Investment Conference being held September 8-10, 2025. The presentation will be available on demand on Monday, September 8, 2025 at 7:00 a.m. ET. In addition, replays from other recent investor events are available on the Opus Genetics’ website, including: Nasdaq Spotlight interviewChardan Virtual Ophthalmology Summit Series on Rare Ophthalmic Diseases Fireside ChatJones Trading Virtual Presbyopia Expert Panel Links to these webcasts may be accessed on the Opus Genetics website under the Investors section: Events. About Opus Genetics Opus Genetics is a clinical-stage biopharmaceutical company developing gene therapies for the treatment of inherited retinal diseases (IRDs) and small molecule therapies for other ophthalmic disorders. The Company’s pipeline features AAV-based gene therapies targeting inherited retinal diseases including Leber congenital amaurosis (LCA), bestrophinopathy, and retinitis pigmentosa. Its lead gene therapy candidates are OPGx-LCA5, which is in an ongoing Phase 1/2 trial for LCA5-related mutations, and OPGx-BEST1, a gene therapy targeting BEST1-related retinal degeneration. Opus Genetics is also advancing Phentolamine Ophthalmic Solution 0.75%, a partnered therapy currently approved in one indication and being studied in two Phase 3 programs for presbyopia and reduced low light vision and nighttime visual disturbances. The Company is based in Research Triangle Park, NC. For more information, visit www.opusgtx.com. Contacts: InvestorsJenny KobinRemy BernardaIR Advisory Solutionsir@opusgtx.com MediaKimberly HaKKH Advisors917-291-5744kimberly.ha@kkhadvisors.com Source: Opus Genetics, Inc.

Phase 3Gene Therapy

27 Aug 2025

·www.prnewswire.com

American Regent® Launches Gvoke VialDx™ (glucagon injection)

First concentrated, ready-to-dilute liquid glucagon available for diagnostic procedures SHIRLEY, N.Y., Aug. 27, 2025 /PRNewswire/ -- American Regent, Inc.® is pleased to announce the commercial launch and availability of Gvoke VialDx™ (glucagon injection). Gvoke VialDx (glucagon injection) is a gastrointestinal motility inhibitor indicated for intravenous use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients. Gvoke VialDx (glucagon injection) vial The launch of Gvoke VialDx is the result of a partnership between American Regent and Xeris Pharmaceuticals, Inc. Under the terms of the agreement, Xeris will be responsible for product supply, and American Regent will be responsible for the commercialization of Gvoke VialDx in the U.S. Joann Gioia, Vice President and Chief Commercial Officer at American Regent, said, "We are eager to bring our commercial expertise in the hospital and acute care setting to our partnership with Xeris and contribute to the success of Gvoke VialDx. The addition of Gvoke VialDx to our portfolio aligns perfectly with our mission to provide patients with the essential medicines they need." "We're proud to mark the commercial launch of Gvoke VialDx in partnership with American Regent. Gvoke VialDx is the first liquid glucagon available for use as a diagnostic aid and provides an important new option for hospitals and clinics. American Regent is a natural partner to commercialize Gvoke VialDx given their longstanding reputation as a leading provider of high-quality sterile injectable products," said Kevin McCulloch, President and COO of Xeris. Gvoke VialDx will be available as a 1-count, or 10-count package of 1 mg per 0.2 mL single-dose vials and is available for immediate shipment. Customers can order the product through their wholesaler, distributor, or by contacting the American Regent Customer Support Group at 1-800-645-1706. Please see the Important Safety Information below. To view the Full Prescribing Information, please click here. For additional information on Gvoke VialDx, please visit . IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS GVOKE VialDx is contraindicated in patients with: Pheochromocytoma, because of the risk of substantial increase in blood pressure Insulinoma, because of the risk of hypoglycemia Prior hypersensitivity reaction to glucagon or to any of the excipients in GVOKE VialDx. Serious hypersensitivity reactions have been reported with glucagon and include anaphylactic shock with breathing difficulties and hypotension Glucagonoma, because of risk of hypoglycemia. WARNINGS AND PRECAUTIONS Substantial Increase in Blood Pressure in Patients with Pheochromocytoma GVOKE VialDx is contraindicated in patients with pheochromocytoma because glucagon may stimulate the release of catecholamines from the tumor. If the patient develops a substantial increase in blood pressure and a previously undiagnosed pheochromocytoma is suspected, 5 to 10 mg of phentolamine mesylate, administered intravenously, has been shown to be effective in lowering blood pressure. Hypoglycemia in Patients with Insulinoma In patients with insulinoma, administration of glucagon may produce an initial increase in blood glucose; however, glucagon administration may directly or indirectly (through an initial rise in blood glucose) stimulate exaggerated insulin release from an insulinoma and cause hypoglycemia. GVOKE VialDx is contraindicated in patients with insulinoma. If a patient develops symptoms of hypoglycemia after a dose of GVOKE VialDx, give glucose orally or intravenously. Serious Hypersensitivity Reactions Serious hypersensitivity reactions have been reported with glucagon products, including generalized rash, and in some cases anaphylactic shock with breathing difficulties and hypotension. Discontinue GVOKE VialDx if symptoms of serious hypersensitivity reactions occur. Advise patients and/or caregivers to seek immediate medical attention if the patient experiences any symptoms of serious hypersensitivity reactions. GVOKE VialDx is contraindicated in patients with a prior hypersensitivity reaction to glucagon, or any of the excipients in GVOKE VialDx. Necrolytic Migratory Erythema (NME) NME, a skin rash commonly associated with glucagonomas (glucagon-producing tumors) and characterized by scaly, pruritic erythematous plaques, bullae, and erosions, has been reported post marketing following continuous glucagon infusion. GVOKE VialDx is not approved for continuous infusion. NME lesions may affect the face, groin, perineum, and legs or be more widespread. In the reported cases, NME resolved with discontinuation of the glucagon, and treatment with corticosteroids was not effective. Should NME occur, consider whether the benefits of continuous glucagon infusion outweigh the risks. Hyperglycemia With Intravenous Use as a Diagnostic Aid in Patients with Diabetes Mellitus GVOKE VialDx in patients with diabetes mellitus may cause hyperglycemia. Monitor patients with diabetes for changes in blood glucose levels during treatment with GVOKE VialDx and treat hyperglycemia, if indicated. Blood Pressure and Heart Rate Increase in Patients with Cardiac Disease When Used as a Diagnostic Aid GVOKE VialDx may increase myocardial oxygen demand, blood pressure, and pulse rate, which may be life-threatening in patients with cardiac disease. Cardiac monitoring is recommended in patients with cardiac disease during use of GVOKE VialDx as a diagnostic aid, and an increase in blood pressure and pulse rate may require therapy. Hypoglycemia in Patients with Glucagonoma GVOKE VialDx administered to patients with glucagonoma may cause secondary hypoglycemia. GVOKE VialDx is contraindicated in patients with glucagonoma when used as a diagnostic aid. Test patients suspected of having glucagonoma for blood levels of glucagon prior to treatment and monitor for changes in blood glucose levels during treatment. If a patient develops symptoms of hypoglycemia after a dose of GVOKE VialDx, give glucose orally or intravenously. ADVERSE REACTIONS Clinical Trials Experience The most common adverse reactions occurring in ≥5% of adult healthy volunteers who received 0.75 mg GVOKE VialDx intravenously were nausea, dysgeusia, headache, hot flush, and dizziness. Postmarketing Experience The following reactions have been identified during post-approval use of glucagon. Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Necrolytic migratory erythema (NME) cases have been reported postmarketing in patients receiving continuous infusion of glucagon Hypoglycemia and hypoglycemic coma. Patients taking indomethacin may be more likely to experience hypoglycemia following glucagon administration DRUG INTERACTIONS Patients taking beta-blockers may have a transient increase in pulse and blood pressure when given GVOKE VialDx. Insulin acts antagonistically to glucagon. The concomitant use of anticholinergic drugs and GVOKE VialDx increases the risk of gastrointestinal adverse reactions due to additive effects on inhibition of gastrointestinal motility. GVOKE VialDx may increase the anticoagulant effect of warfarin. USE IN SPECIFIC POPULATIONS Pediatric Use Safety and effectiveness of GVOKE VialDx for use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in pediatric patients have not been established. Geriatric Use Clinical studies of GVOKE VialDx did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger adult patients. OVERDOSAGE If overdosage occurs, the patient may experience nausea, vomiting, inhibition of GI tract motility, increase in blood pressure, and pulse rate. In case of suspected overdosing, serum potassium may decrease and should be monitored and corrected if needed. If the patient develops a dramatic increase in blood pressure, phentolamine mesylate has been shown to be effective in lowering blood pressure for the short time that control would be needed. INDICATIONS AND USAGE GVOKE VialDx is indicated for intravenous use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients. Please see Full Prescribing Information. You are encouraged to report Adverse Drug Events to Xeris Pharmaceuticals, Inc. at 1-877-937-4737, or to the FDA by visiting , or by calling 1-800-FDA-1088. About American Regent American Regent, Inc.®, a Daiichi Sankyo Group company, is an industry-leading injectable manufacturer. For over 50 years, American Regent has been developing, manufacturing, and supplying quality generic and branded injectables for healthcare providers. For more than 20 years, we have been a leader in IV iron therapy. American Regent is committed to US-based manufacturing. To that end, over the last several years we have made significant investments in expanding and modernizing our manufacturing facilities in Ohio and New York. This expansion will nearly double our capacity and allow us to better serve our customers now and in the future. Speed counts. Flexibility matters. Reliability and quality are paramount. Because patients should never have to wait for the medications they need. For more information, please visit About Xeris Xeris Pharmaceuticals, Inc., a wholly owned subsidiary of Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), is a fast-growing biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapies. Xeris has three commercially available products: Recorlev®, for the treatment of endogenous hypercortisolemia in patients with Cushing's syndrome; Gvoke®, a ready-to-use liquid glucagon for the treatment of severe hypoglycemia, and a gastrointestinal motility inhibitor when used during radiology exams as a diagnostic aid; and Keveyis®, a proven therapy for primary periodic paralysis. Xeris also has a pipeline of development programs led by XP-8121, a Phase 3-ready, once-weekly subcutaneous injection for hypothyroidism, as well as multiple early-stage programs leveraging Xeris' technology platforms, XeriSol® and XeriJect®, for its partners. Xeris Biopharma Holdings, Inc. is headquartered in Chicago, IL. For more information, visit , or follow on X, LinkedIn, or Instagram. All trademarks are the property of their respective owners.© 2025 American Regent, Inc. All rights reserved. PP-GL-US-0005 SOURCE American Regent, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

License out/inDrug Approval

100 Deals associated with Phentolamine Mesylate

External Link

KEGG	Wiki	ATC	Drug Bank
D00509	Phentolamine Mesylate	V03AB36 C04AB01	DB00692

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Mydriasis	United States	Famy Life Sciences Pvt Ltd.	25 Sep 2023
Erectile Dysfunction	China	Shanghai Fudan Forward Pharmaceutical Co. Ltd.	01 Jan 1989
Anesthesia	United States	Novartis Pharmaceuticals Corp.	30 Jan 1952

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Night Blindness	Phase 3	United States	Opus Genetics, Inc.	27 Apr 2023
Presbyopia	Phase 3	United States	Opus Genetics, Inc.	22 Dec 2022
Vision, Low	Phase 3	United States	Opus Genetics, Inc.	30 Dec 2020
Glaucoma, Open-Angle	Phase 2	United States	Opus Genetics, Inc.	28 May 2019
Blindness	Phase 2	United States	Opus Genetics, Inc.	09 Sep 2011

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06542497 (VEGA-3, Company_Website) Manual	Phase 3	Presbyopia	545	Phentolamine Ophthalmic Solution 0.75%	edflnukngh(ghdipebblc) = pmwooafjgb zgcdajcigs (ublyblvvdi ) Met View more	Positive	26 Jun 2025
				Placebo	edflnukngh(ghdipebblc) = oorurlyxwn zgcdajcigs (ublyblvvdi ) Met View more
NCT05646719 (VEGA-2, CTgov)	Phase 3	Presbyopia	333	Phentolamine Opthalmic Solution 0.75%+Low dose pilocarpine (Nyxol + Low Dose Pilocarpine)	lfhqyfwlro = mmyksvljmw zavjpvomis (yiczannuhh, hwwblqhvtk - ordbsduief) View more	-	03 Jun 2025
				Low dose pilocarpine vehicle+Phentolamine Opthalmic Solution 0.75% (Nyxol + Low Dose Pilocarpine Vehicle)	lfhqyfwlro = agxefclpcz zavjpvomis (yiczannuhh, zctbuazgwz - ayirbulsuq) View more
NCT04620213 \| NCT05134974 (MIRA-3, Literature) Manual	Phase 3	Mydriasis	553	phentolamine	tvrzfcobfo(jsgmfjwwto) = bgifktlmqc mlqijsvchi (cnuprzfrnp )	Positive	16 Sep 2024
				placebo	tvrzfcobfo(jsgmfjwwto) = iwcsaaxtea mlqijsvchi (cnuprzfrnp )
NCT04004507 (SNV, CTgov)	Phase 2	Night Blindness \| Blindness	24	Phentolamine Mesylate Ophthalmic Solution 1% (Phentolamine Mesylate Ophthalmic Solution 1%)	rdcaedjsjl(ecopxpucih) = zhfiqlemef jmisgdkxxr (yvdykucqpj, 1.8) View more	-	15 Feb 2024
				Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo) (Phentolamine Mesylate Ophthalmic Solution Vehicle)	rdcaedjsjl(ecopxpucih) = lmiwhewmvc jmisgdkxxr (yvdykucqpj, 1.5) View more
NCT04620213 \| NCT05134974 (MIRA-3, FDA) Manual	Phase 3	Mydriasis	553	Ryzumvi (MIRA-2)	pvsrzlmtzc(ckfpjzmatw) = mneplbbhvr fjawjfvlum (eusmacadzo )	Positive	25 Sep 2023
				Placebo (MIRA-2)	pvsrzlmtzc(ckfpjzmatw) = ywcnqyhjxz fjawjfvlum (eusmacadzo )
NCT04620213 (MIRA-2, CTgov)	Phase 3	Mydriasis	185	Phentolamine Ophthalmic Solution 0.75% (Phentolamine Ophthalmic Solution 0.75%)	jrmrxwjkhj = hwglvvxzfn jhkkgilsnk (kbebcfojcd, elrjtdblyj - gkasgfkscw) View more	-	14 Aug 2023
				Phentolamine Ophthalmic Solution Vehicle (Placebo) (Phentolamine Ophthalmic Solution Vehicle)	jrmrxwjkhj = vgzesidvbz jhkkgilsnk (kbebcfojcd, whnryqimcv - vqrjtbvlya) View more
NCT04638660 (LYNX-1, CTgov)	Phase 3	Vision, Low	144	Phentolamine Ophthalmic Solution 0.75% (Phentolamine Ophthalmic Solution 0.75%)	xdiomhbbvb = vswskfmxgc berfxolhob (oulxncykcq, olgeyypyba - chbfmaeser) View more	-	09 Aug 2023
				Phentolamine Ophthalmic Solution Vehicle (Placebo) (Phentolamine Ophthalmic Solution Vehicle)	xdiomhbbvb = qbiovyverh berfxolhob (oulxncykcq, jgdlrfmckd - ejgjruksvi) View more
NCT04675151 (CTgov)	Phase 2	Presbyopia	150	LDP+POS (POS 0.75% First, Then LDP 0.4%)	bbncppcjjd = uyhyhqpnxk nsngdzxicn (aewfhfvzps, jikruzdpff - muhluqayju) View more	-	02 Aug 2023
				LDP+POS (POS 0.75% First, Then LDP Vehicle)	bbncppcjjd = vlkelemkze nsngdzxicn (aewfhfvzps, capeaaacel - rmxftnphey) View more
NCT05223478 (MIRA-4, CTgov)	Phase 3	Mydriasis	23	Phentolamine Ophthalmic Solution 0.75% (Phentolamine Ophthalmic Solution 0.75%)	kntiutncir(krszesiyfb) = kbjhnpotuy luxtgtxhuu (utsbqovfjh, 0.65) View more	-	02 Aug 2023
				Phentolamine Ophthalmic Solution Vehicle (Phentolamine Ophthalmic Solution Vehicle)	kntiutncir(krszesiyfb) = fqanaorrnz luxtgtxhuu (utsbqovfjh, 0.58) View more
NCT05134974 (MIRA-3, CTgov)	Phase 3	Mydriasis	368	Phentolamine Ophthalmic Solution 0.75% (Phentolamine Ophthalmic Solution 0.75%)	coomymskez(ogiyojhule) = brawfzcoab ukixriuvhk (iiywuuvxzp, 0.7104) View more	-	01 Aug 2023
				Phentolamine Ophthalmic Solution Vehicle (Phentolamine Ophthalmic Solution Vehicle)	coomymskez(ogiyojhule) = owoguzwtsn ukixriuvhk (iiywuuvxzp, 0.5335) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

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

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

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