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.

NCT06787066

/ RecruitingEarly Phase 1IIT

Sympathetic Vascular Transduction Across the Menopause Transition: Contributing Mechanisms

The investigators aim to assess the interactions between the sympathetic nervous system and the vasculature in women across the menopause transition to better understand why aging women have a higher risk of cardiovascular disease.

Start Date10 Jul 2025

Sponsor / Collaborator

University of Missouri

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

100 Clinical Results associated with Phentolamine Mesylate

100 Translational Medicine associated with Phentolamine Mesylate

100 Patents (Medical) associated with Phentolamine Mesylate

12,065

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.

12 Sep 2025·JOURNAL OF ORGANIC CHEMISTRY

One-Pot Metal-Free Synthesis of Diarylamines from Aromatic Aldehydes and Anilines

Article

Author: Furman, Bartłomiej ; Szcześniak, Piotr

A novel and environmentally friendly method has been developed for the synthesis of a broad range of diarylamines from inexpensive and readily available starting materials, such as aromatic aldehydes and amines. The process follows a one-pot strategy in which imine formation is succeeded by an oxidative rearrangement analogous to the Meinwald reaction and concludes with a light-induced deformylation step. This efficient transformation proceeds in a single vessel with a high atom economy under mild, metal-free conditions. The methodology was further demonstrated as a key step in the synthesis of phentolamine, a reversible, nonselective α-adrenergic blocker used in the treatment of hypertensive emergencies.

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.

159

News (Medical) associated with Phentolamine Mesylate

30 Sep 2025

·www.globenewswire.com

Opus Genetics Reports Positive Pediatric Data from OPGx-LCA5 Phase 1/2 Trial in Leber Congenital Amaurosis Type 5 (LCA5)

Pediatric participants demonstrated large gains in cone-mediated vision; therapy remains well tolerated with no ocular serious adverse events or dose-limiting toxicitiesLasting, durable responses observed out to 18 months in adult participantsExpected FDA Meeting in Q4 2025Management to Host Webcast and Conference Call Today at 8:30 A.M. ET RESEARCH TRIANGLE PARK, N.C., Sept. 30, 2025 (GLOBE NEWSWIRE) -- Opus Genetics, Inc. (Nasdaq: IRD), a clinical-stage biopharmaceutical company developing gene therapies for the treatment of inherited retinal diseases (IRDs) and small molecule therapies for other ophthalmic disorders, today announced positive three-month data from the pediatric cohort of its ongoing Phase 1/2 clinical trial (OPGx-LCA5-1001) evaluating OPGx-LCA5, an investigational gene augmentation therapy for Leber congenital amaurosis type 5 (LCA5). “These pediatric results are particularly exciting, as they provide evidence that OPGx-LCA5 can potentially restore cone-mediated vision in teenagers who had already experienced profound vision loss,” said George Magrath, M.D., Chief Executive Officer, Opus Genetics. “These outcomes, alongside observed durable improvements observed in adults out to 18 months, give us confidence in the potential for OPGx-LCA5 to deliver meaningful and lasting benefit to patients. We expect to meet with the U.S. Food and Drug Administration (FDA) in the fourth quarter of this year to discuss these results and the next steps for our LCA5 program targeting this ultra-rare disease.” Three pediatric participants aged 16-17 with severe baseline vision impairment received a single subretinal injection of OPGx-LCA5. All three participants had improvements across multiple measures of visual function, as described below: Visual Acuity (VA):For the pediatric cohort, early data showed a group average of a 0.3 logMAR improvement which is greater than was observed in the adult cohort. Participant 01-05 had a baseline visual acuity of 2.2 logMAR with an improvement of 0.5 logMAR reported at one month.Participant 01-06 had a baseline visual acuity of 0.96 logMAR with an improvement of 0.2 logMAR reported at three months. They reported perceiving a clear difference in brightness between their treated and untreated eyes.Participant 01-07 had a baseline visual acuity of 2.3 logMAR with an improvement of 0.7 logMAR reported at one month, which was maintained through three months. Full-Field Stimulus Testing (FST):All three participants showed improvements in the treated eyes from one month. Participants showed greater than one (>1) log unit improvement in cone sensitivity to both red and blue light. These changes provide evidence of recovery in retinal sensitivity.Multi-Luminance Orientation and Mobility Test (MLoMT):All participants identified more objects through three-months compared to baseline. Two out of the three participants had greater improvement in the treated eye compared to the control eye.Microperimetry:Two of the three pediatric participants could not conduct a microperimetry test due to their poor visual acuity and nystagmus at screening. However, microperimetry data was obtained on one participant, for whom early signs of improved fixation stability were observed, consistent with functional retinal recovery. In addition, combined adult data support that improvements in visual acuity were sustained through 18 months, both in terms of mean change from baseline and mean interocular difference, underscoring the potential durability of the treatment response. OPGx-LCA5 has been well-tolerated in all six participants treated to date (three adults and three pediatric participants). No ocular serious adverse events or dose-limiting toxicities have been observed. All ocular adverse events were mild in severity and were anticipated. No events were related to the study drug. One pediatric participant had a pre-existing cataract that worsened at three months, which was attributed to the surgical procedure itself and did not obscure improvements in retinal sensitivity. “Seeing pediatric participants achieve measurable improvements in visual acuity, retinal sensitivity, and real-world navigation tasks within three months and adult participants maintaining those improvements is a remarkable step forward,” said Tomas S. Aleman, M.D., of the Scheie Eye Institute, University of Pennsylvania and principal investigator of the study. “This is important evidence supporting that gene augmentation therapy can potentially restore cone function in patients with LCA5.” Conference Call & Webcast Details Opus Genetics management will host a webcast and conference call today at 8:30 a.m. Eastern Time to discuss the OPGx-LCA5 clinical trial data. The live and archived webcast may be accessed on the Opus Genetics website under the Investors section: Events. The live call can be accessed by dialing 888-506-0062 (domestic) or 973-528-0011 (international) and entering conference code: 906168. Opus Genetics suggests participants join 15 minutes in advance of the event. About the OPGx-LCA5-1001 Phase 1/2 Clinical Trial The OPGx-LCA5-1001 trial is a Phase 1/2 open-label, ascending-dose study evaluating the safety and preliminary efficacy of OPGx-LCA5 administered via subretinal injection in participants with inherited retinal degeneration due to biallelic mutations in the LCA5 gene. The trial has enrolled a total of six participants: three adults and three pediatric participants. Efficacy evaluations include measurements of visual acuity; Full-Field Stimulus Testing (FST), which measures the retina's sensitivity to light; performance outcomes on the Multi-Luminance orientation and Mobility Test (MLoMT); and microperimetry, which measures point-wise sensitivity to light. For more information, visit clinicaltrials.gov (NCT05616793). About OPGx-LCA5 OPGx-LCA5 is designed to address a form of Leber congenital amaurosis (LCA) due to biallelic mutations in the LCA5 gene (LCA5), which encodes the lebercilin protein. LCA5-associated inherited retinal disease is an early-onset severe inherited retinal dystrophy. Studies in patients with this mutation have reported evidence for the dissociation of retinal architecture and visual function in this disease, suggesting an opportunity for therapeutic intervention through gene augmentation. OPGx-LCA5 uses an adeno-associated virus 8 (AAV8) vector to precisely deliver a functional LCA5 gene to the outer retina. OPGx-LCA5 is currently being evaluated in a Phase 1/2 clinical trial at the University of Pennsylvania. Data from pediatric participants demonstrated large gains in cone-mediated vision, and the therapy remains well tolerated with no ocular serious adverse events or dose-limiting toxicities. The adult cohort showed durable improvements in cone sensitivity and visual function out to 18 months. OPGx-LCA5 has received Rare Pediatric Disease, Orphan Drug and Regenerative Medicine Advanced Therapy (RMAT) designations from the FDA. About Leber Congenital Amaurosis (LCA) and LCA5 Leber congenital amaurosis (LCA) is a group of inherited retinal diseases characterized by severe impaired vision or blindness at birth. Some retinal experts consider LCA to be a severe form of retinitis pigmentosa (RP). The condition is caused by degeneration and/or dysfunction of photoreceptors, the cells in the retina that make vision possible. Mutations in one of more than two dozen genes can cause LCA. LCA5 is an ultra-rare disease caused by mutations in the LCA5 gene, which encodes lebercilin, a protein essential for photoreceptor structure and function. LCA5 accounts for roughly 2% of all LCA cases, or approximately 200 patients. There are currently no approved therapies for LCA5-related inherited retinal degeneration, making gene therapy a potentially transformative approach. 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, please 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 the clinical development of, and clinical results and future plans for, OPGx-LCA5, potential meetings with the FDA regarding our OPGx-LCA5 program, and 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 in 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 of this press release. 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.

Clinical ResultOrphan DrugPhase 3Gene TherapyClinical Study

23 Sep 2025

·www.prnewswire.com

Endo Expands ADRENALIN® Ready-to-Use Premixed Bag Line with Three New Concentrations

Endo adds ADRENALIN® premixed IV bags in concentrations of 2 mg, 5 mg, and 10 mg per 250 mL. Endo now offers ADRENALIN® premixed IV bags in five of the most used concentrations, including the 5 mg and 10 mg which align with ASHP's Standardize 4 Safety Initiative Endo's products are the first FDA-approved, commercially available manufacturer-prepared epinephrine premixed intravenous (IV) bag. MALVERN, Pa., Sept. 23, 2025 /PRNewswire/ -- Endo, a wholly-owned subsidiary of Mallinckrodt plc, announced today the launch of ADRENALIN® (epinephrine in 0.9% sodium chloride injection) premixed IV bags in three new concentrations: 2 mg/250 mL, 5 mg/250 mL (20 mcg/mL), and 10 mg/250 mL (40 mcg/mL). With this launch, Endo expands its ADRENALIN® portfolio to include premixed IV bags in five concentrations: 2 mg, 4 mg, 5 mg, 8 mg, and 10 mg per 250 mL. The portfolio also includes ADRENALIN® (epinephrine injection, USP) in 1 mL single-dose and 30 mL multi-dose vials. The 5 mg/250 mL and 10 mg/250 mL concentrations align with the American Society of Health-System Pharmacists (ASHP) Standardize 4 Safety Initiative, supporting efforts to reduce medication errors and enhance patient safety. ADRENALIN® is the first FDA-approved, commercially available manufacturer-prepared epinephrine premixed IV bag, offering healthcare providers a ready-to-use solution that supports streamlined care delivery. "We're proud to support hospital teams with ready-to-use medicines that help make care easier and more efficient," said Scott Sims, Senior Vice President and General Manager, Endo Injectable Solutions and Generics. "We're excited to grow our TruDelivery® portfolio and give providers more options to focus on what matters most–caring for patients." Key product benefits include: No compounding or preparation required Single-port IV tubing to reduce the risk of inadvertent mixture 24-month shelf life at room temperature ADRENALIN® premixed IV bag is indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. The ADRENALIN® premixed IV bag is part of Endo's TruDelivery® product line and platform. Ready-to-use products streamline operations for hospitals by eliminating the need to prepare or transfer the product before patient administration. This may reduce waste and costs, optimize convenience and workflow, and reduce the chance for preparation error—all of which support quality patient care. About ASHP and Standardize 4 Safety Initiative ASHP, the largest association of pharmacy professionals in the U.S., received funding from the FDA's Safe Use Initiative to develop and implement national standardized concentrations for intravenous (IV) and oral liquid medications. This effort led to the creation of Standardize 4 Safety, the first national, interprofessional initiative aimed at reducing medication errors—especially during transitions of care. Developed in collaboration with pharmacists, nurses, and physicians across the care continuum, the initiative provides standardized concentration lists for patients of all ages in settings from hospital to home. Hospitals and health systems are encouraged to adopt these lists to enhance safety and reduce errors. Additional lists are forthcoming, and professionals can register with ASHP to receive updates. For more information, visit ashp.org. IMPORTANT SAFETY INFORMATION WARNINGS AND PRECAUTIONS Hypertension: Because individual response to epinephrine may vary significantly, monitor blood pressure frequently and titrate to avoid excessive increases in blood pressure. Patients receiving monoamine oxidase inhibitors (MAOI) or antidepressants of the triptyline or imipramine types may experience severe, prolonged hypertension when given epinephrine. Pulmonary Edema: Epinephrine increases cardiac output and causes peripheral vasoconstriction, which may result in pulmonary edema. Cardiac Arrhythmias and Ischemia: Epinephrine may induce cardiac arrhythmias and myocardial ischemia in patients, especially patients suffering from coronary artery disease, or cardiomyopathy. Extravasation and Tissue Necrosis with Intravenous Infusion: Avoid extravasation of epinephrine into the tissues, to prevent local necrosis. When ADRENALIN® premixed IV bag is administered intravenously, check the infusion site frequently for free flow. Blanching along the course of the infused vein, sometimes without obvious extravasation, may be attributed to vasa vasorum constriction with increased permeability of the vein wall, permitting some leakage. This also may progress on rare occasions to superficial slough. Hence, if blanching occurs, consider changing the infusion site at intervals to allow the effects of local vasoconstriction to subside. There is potential for gangrene in a lower extremity when infusions of catecholamine are given in an ankle vein. Antidote for Extravasation Ischemia: To prevent sloughing and necrosis in areas in which extravasation has taken place, infiltrate the area with 10 mL to 15 mL of saline solution containing from 5 mg to 10 mg of phentolamine, an adrenergic blocking agent. Use a syringe with a fine hypodermic needle, with the solution being infiltrated liberally throughout the area, which is easily identified by its cold, hard, and pallid appearance. Sympathetic blockade with phentolamine causes immediate and conspicuous local hyperemic changes if the area is infiltrated within 12 hours. Renal Impairment: Epinephrine constricts renal blood vessels, which may result in oliguria or renal impairment. ADVERSE REACTIONS: Most common adverse reactions to systemically administered epinephrine are headache; anxiety; apprehensiveness; restlessness; tremor; weakness; dizziness; sweating; palpitations; pallor; peripheral coldness; nausea/vomiting; and/or respiratory difficulties. Arrhythmias, including fatal ventricular fibrillation, rapid rises in blood pressure producing cerebral hemorrhage, and angina have occurred. DRUG INTERACTIONS: Drugs that counter the pressor effects of epinephrine include alpha blockers, vasodilators such as nitrates, diuretics, antihypertensives, and ergot alkaloids. Drugs that potentiate the effects of epinephrine include sympathomimetics, beta blockers, tricyclic antidepressants, MAO inhibitors, catechol-O-methyltransferase (COMT) inhibitors, clonidine, doxapram, oxytocin, levothyroxine sodium, and certain antihistamines. Drugs that increase the arrhythmogenic potential of epinephrine include beta blockers, cyclopropane and halogenated hydrocarbon anesthetics, antihistamines, exogenous thyroid hormones, diuretics, cardiac glycosides, and quinidine. Observe for development of cardiac arrhythmias. Potassium-depleting drugs, including corticosteroids, diuretics, and theophylline, potentiate the hypokalemic effects of epinephrine. USE IN SPECIFIC POPULATIONS: Elderly patients and pregnant women may be at greater risk of developing adverse reactions when epinephrine is administered parenterally. Click for Full Prescribing Information. About Endo Endo, a wholly owned subsidiary of Mallinckrodt plc, is a diversified therapeutics manufacturer boldly transforming insights into life-enhancing therapies. Our passionate team members collaborate to develop and deliver these essential medicines. Together, we are committed to helping everyone we serve live their best life. Learn more at or connect with us on LinkedIn. Cautionary Note Regarding Forward-Looking Statements This release contains forward-looking statements, including with regard to product efficacy, potential treatments or indications, therapeutic outcomes or treatment responses, and any statements that refer to expected, estimated or anticipated future results or that do not relate solely to historical facts. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: the effects of each of Endo's and Mallinckrodt's recent emergences from bankruptcy; satisfaction of, and compliance with, regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; changes in market demand; issues with product quality, manufacturing or supply, or patient safety issues or adverse side effects or adverse reactions associated with our products; and other risks identified and described in more detail in the "Risk Factors" and the "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Endo's and Mallinckrodt's most recent Annual Reports on Form 10-K, Mallinckrodt's Registration Statement on Form S-4, as amended, and other filings with the Securities and Exchange Commission (SEC), all of which are available from the SEC's website () and Mallinckrodt's website (). The forward-looking statements made herein speak only as of the date hereof and we do not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise, except as required by law. SOURCE Endo USA, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug Approval

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

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.

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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.

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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

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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%	rjeewoadkr(mawloglisa) = lmzrpihlcp lymtkfiant (yqyrawyuwq ) Met View more	Positive	26 Jun 2025
				Placebo	rjeewoadkr(mawloglisa) = odjagzxcst lymtkfiant (yqyrawyuwq ) Met View more
NCT05646719 (VEGA-2, CTgov)	Phase 3	Presbyopia	333	Phentolamine Opthalmic Solution 0.75%+Low dose pilocarpine (Nyxol + Low Dose Pilocarpine)	peqrzrawzy = qktyjmxaao sckbszajqd (uigzfovarr, tfiydyrhhn - hzoqjqyfnm) View more	-	03 Jun 2025
				Low dose pilocarpine vehicle+Phentolamine Opthalmic Solution 0.75% (Nyxol + Low Dose Pilocarpine Vehicle)	peqrzrawzy = fvmfzvkbrk sckbszajqd (uigzfovarr, nkcfubkjos - eyiywgwwgv) View more
NCT04620213 \| NCT05134974 (MIRA-3, Literature) Manual	Phase 3	Mydriasis	553	phentolamine	ztmslvdtgw(dlnspaqrzw) = yeypxnfvrb eqtgohhply (zknzwatxuw )	Positive	16 Sep 2024
				placebo	ztmslvdtgw(dlnspaqrzw) = kjxzjwwywj eqtgohhply (zknzwatxuw )
NCT04004507 (SNV, CTgov)	Phase 2	Night Blindness \| Blindness	24	Phentolamine Mesylate Ophthalmic Solution 1% (Phentolamine Mesylate Ophthalmic Solution 1%)	voahfbmzpj(iiwqysvtvt) = wmgtolxwdd qqorfxnrfa (wctbvdhoza, 1.8) View more	-	15 Feb 2024
				Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo) (Phentolamine Mesylate Ophthalmic Solution Vehicle)	voahfbmzpj(iiwqysvtvt) = pramojfxyh qqorfxnrfa (wctbvdhoza, 1.5) View more
NCT04620213 \| NCT05134974 (MIRA-3, FDA) Manual	Phase 3	Mydriasis	553	Ryzumvi (MIRA-2)	alvfarxjvz(sksjhrjlde) = ycbjexjagr anrcvnfkpm (zqaugkwlhq )	Positive	25 Sep 2023
				Placebo (MIRA-2)	alvfarxjvz(sksjhrjlde) = wjpoplhboj anrcvnfkpm (zqaugkwlhq )
NCT04620213 (MIRA-2, CTgov)	Phase 3	Mydriasis	185	Phentolamine Ophthalmic Solution 0.75% (Phentolamine Ophthalmic Solution 0.75%)	ymnjrpsfey = mmwqxgbvib wudlofjobu (tprbyrzspk, unswrzvwkd - lippfyzfgk) View more	-	14 Aug 2023
				Phentolamine Ophthalmic Solution Vehicle (Placebo) (Phentolamine Ophthalmic Solution Vehicle)	ymnjrpsfey = kudfvtqhga wudlofjobu (tprbyrzspk, sdagsaibng - qwyolsfunp) View more
NCT04638660 (LYNX-1, CTgov)	Phase 3	Vision, Low	144	Phentolamine Ophthalmic Solution 0.75% (Phentolamine Ophthalmic Solution 0.75%)	ggtyrgknsc = ymgjnlquoy hqggrrivzo (buowzubghf, epddvlpofo - pmfjlajuoy) View more	-	09 Aug 2023
				Phentolamine Ophthalmic Solution Vehicle (Placebo) (Phentolamine Ophthalmic Solution Vehicle)	ggtyrgknsc = bgwvszczwg hqggrrivzo (buowzubghf, ygsemrxwqr - yguperenzt) View more
NCT05223478 (MIRA-4, CTgov)	Phase 3	Mydriasis	23	Phentolamine Ophthalmic Solution 0.75% (Phentolamine Ophthalmic Solution 0.75%)	szpqackhbp(zqkjohwzwj) = shljtmmebf jxpejkteol (zdurapnosf, 0.65) View more	-	02 Aug 2023
				Phentolamine Ophthalmic Solution Vehicle (Phentolamine Ophthalmic Solution Vehicle)	szpqackhbp(zqkjohwzwj) = teyvjvdrtj jxpejkteol (zdurapnosf, 0.58) View more
NCT04675151 (CTgov)	Phase 2	Presbyopia	150	LDP+POS (POS 0.75% First, Then LDP 0.4%)	pfxetrzujw = fekefhdrol sctrzgzyqw (wjsmnpnnwd, tfytosvkhh - apngehcqoc) View more	-	02 Aug 2023
				LDP+POS (POS 0.75% First, Then LDP Vehicle)	pfxetrzujw = kmechylrgc sctrzgzyqw (wjsmnpnnwd, ugrvvkuukt - qlrolfaiee) View more
NCT05134974 (MIRA-3, CTgov)	Phase 3	Mydriasis	368	Phentolamine Ophthalmic Solution 0.75% (Phentolamine Ophthalmic Solution 0.75%)	vbtabkkfut(tptridqroo) = jvdprlqlfo zlifdrbmjh (mckxvmygao, 0.7104) View more	-	01 Aug 2023
				Phentolamine Ophthalmic Solution Vehicle (Phentolamine Ophthalmic Solution Vehicle)	vbtabkkfut(tptridqroo) = yqxjwdhaiw zlifdrbmjh (mckxvmygao, 0.5335) View more

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