Tropicamide

Viatris Announces the Launch of RYZUMVl™ (Phentolamine Ophthalmic Solution) 0.75% in the United States

Retrieved on: 
Monday, April 1, 2024
Glaucoma, Agonist, Rheumatoid arthritis, Phenylephrine, Diabetes, Inflammation, Patient, Ageing, American Optometric Association, Eye injury, American Academy, Mydriasis, United, Viatris, Eye, Parasympatholytic, Uveitis, Lens, Pupil, Tropicamide, FDA, Cataract, Diabetic retinopathy, Food, Pharmaceutical industry

PITTSBURGH, April 1, 2024 /PRNewswire/ -- Viatris Inc. (NASDAQ: VTRS), a global healthcare company, today announced the U.S. commercial launch of RYZUMVI™ (phentolamine ophthalmic solution) 0.75% for the treatment of pharmacologically-induced mydriasis produced by adrenergic agonists (e.g., phenylephrine) or parasympatholytic (e.g., tropicamide) agents in the United States.

Key Points: 
  • PITTSBURGH, April 1, 2024 /PRNewswire/ -- Viatris Inc. (NASDAQ: VTRS), a global healthcare company, today announced the U.S. commercial launch of RYZUMVI™ (phentolamine ophthalmic solution) 0.75% for the treatment of pharmacologically-induced mydriasis produced by adrenergic agonists (e.g., phenylephrine) or parasympatholytic (e.g., tropicamide) agents in the United States.
  • The onset of action of RYZUMVI generally occurs in 30 minutes.
  • In the MIRA-2 trials' placebo group, 34% of patients were still dilated (had not returned to ≤ 0.2 mm of baseline pupil diameter) at 24 hours.
  • To avoid the potential for eye injury or contamination, care should be taken to avoid touching the vial tip to the eye or to any other surface.

Eyenovia Announces FDA Approval of Redwood City as Commercial Manufacturing Facility

Retrieved on: 
Tuesday, February 13, 2024
FDA, Phenylephrine, Engineering, Tropicamide, Pharmaceutical industry

NEW YORK, Feb. 13, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), a commercial-stage ophthalmic company, today announced that the company’s facility in Redwood City, California successfully completed FDA inspection for approval as a commercial manufacturing facility. The Redwood City facility will primarily be used for final assembly, packaging and labeling activities in support of Mydcombi, the first and only fixed combination of tropicamide and phenylephrine for in-office and pre-surgical pupil dilation utilizing Optejet™ technology.

Key Points: 
  • Redwood City, California to complement Eyenovia’s facility in Reno, Nevada as well as its contract manufacturer, Coastline International, to produce commercial supply of Mydcombi
    NEW YORK, Feb. 13, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), a commercial-stage ophthalmic company, today announced that the company’s facility in Redwood City, California successfully completed FDA inspection for approval as a commercial manufacturing facility.
  • The Redwood City facility will primarily be used for final assembly, packaging and labeling activities in support of Mydcombi, the first and only fixed combination of tropicamide and phenylephrine for in-office and pre-surgical pupil dilation utilizing Optejet™ technology.
  • Redwood City complements Eyenovia’s manufacturing capabilities in Reno, as well as its contract manufacturer, Coastline International, to produce commercial supply of Mydcombi in the Company’s proprietary Optejet dispensing platform.
  • “The team had been working tirelessly in preparation for this key milestone and their efforts bore out in the result.”

Eyenovia Reports Third Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Monday, November 13, 2023
CNS, Acquisition, Mydriasis, Audit committee, Telecanthus, Visual acuity, CFO, Headache, Net, Patient, Presbyopia, Research, Element, Tropicamide, Lomb, Growth, Inflammation, Vomiting, Intraocular pressure, ACE, ADT Inc., American Academy, Abnormal psychology, New Drug Application, Nausea, Tachycardia, Mouth, Hypersensitivity, NDA, Allied health professions, International Joint Commission, Photophobia, Psychotic Reaction, Cholinergic, Pilocarpine, Pallor, Reader's Digest, Blood pressure, Bausch, Carbachol, Near-sightedness, Allergy, FDA, Contact, Central nervous system, PDUFA, Hypertonia, Pharmaceutical industry, Management, Nursing, Telescopic sight, Video game, Euronext, Ophthalmology

NEW YORK, Nov. 13, 2023 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), a commercial-stage, topical ophthalmic company leveraging its Optejet® dispensing technology for both internally developed and acquired programs as well as out-licensing for additional indications, today announced its financial and operating results for the third quarter ended September 30, 2023.

Key Points: 
  • Advanced its Gen-2 Optejet device and anticipates shipping to MicroPine partners Bausch and Lomb and Arctic Vision by year-end 2023.
  • Research and development expenses totaled approximately $3.6 million for the third quarter of 2023 as compared to $3.9 million for the third quarter of 2022.
  • For the third quarter of 2023, general and administrative expenses were approximately $2.9 million, compared to $3.4 million for the third quarter of 2022.
  • Total operating expenses for the third quarter of 2023 were approximately $6.5 million compared to $7.2 million for the third quarter of 2022.

Ocuphire Pharma Announces Financial Results for Third Quarter 2023 and Provides Corporate Update

Retrieved on: 
Monday, November 13, 2023
Eye, Food and Drug Administration, Research, Food, Security (finance), Woman, End-user license agreement, American Academy, Patient, Phenylephrine, Presbyopia, FDA, Agonist, Tropicamide, License, Conference, Night vision, OCUP, Met, SPA, Mydriasis, Congress, Diabetic retinopathy, LPC, Pharmaceutical industry, Medical imaging, Cryptocurrency, Viatris, Ophthalmology

FARMINGTON HILLS, Mich., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing small-molecule therapies for the treatment of retinal and refractive eye disorders, today announced financial results for the third quarter ended September 30, 2023 and provided a corporate update.

Key Points: 
  • Named as CEO; Conference Call Scheduled for December 5th, 2023, at 10 AM ET
    FARMINGTON HILLS, Mich., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing small-molecule therapies for the treatment of retinal and refractive eye disorders, today announced financial results for the third quarter ended September 30, 2023 and provided a corporate update.
  • On August 10, 2023, Ocuphire entered into a common share purchase agreement with Lincoln Park Capital Fund, LLC (“LPC”).
  • Third Quarter ended September 30, 2023, Financial Highlights
    As of September 30, 2023, Ocuphire had cash and cash equivalents of approximately $42.4 million.
  • For further details on Ocuphire’s financial results, refer to the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2023, to be filed with the Securities and Exchange Commission.

Eyenovia Announces FDA Approval of Coastline International as Contract Manufacturer to Initiate Mydcombi Commercial Production

Retrieved on: 
Thursday, November 2, 2023
FDA, Phenylephrine, Mydriasis, Pain, Surgeon, Risk, Tropicamide, Inflammation, Shanda, Presbyopia, Pharmaceutical industry, Medical device

Coastline will manufacture cartridge subassemblies for Mydcombi, the only FDA-approved tropicamide and phenylephrine hydrochloride fixed combination for mydriasis (office-based pupil dilation).

Key Points: 
  • Coastline will manufacture cartridge subassemblies for Mydcombi, the only FDA-approved tropicamide and phenylephrine hydrochloride fixed combination for mydriasis (office-based pupil dilation).
  • “One of the many benefits of Mydcombi is that, unlike eye droppers, there is no protruding tip that can come in contact with the patient’s eye.
  • “We believe Mydcombi, because of its design, addresses this challenge and can provide significant cost savings to doctors and surgical centers.
  • With FDA approval of Coastline, our manufacturing capabilities are in place, and we anticipate initiating Mydcombi commercial production imminently with the goal of having product available to ship in January of 2024.”

Eyenovia to Sponsor Course on Drug Delivery Innovation at IJCAHPO’s 51st Annual Continuing Education (ACE) Program

Retrieved on: 
Monday, October 30, 2023
FDA, Refractive surgery, Optometry, Tropicamide, Joint Commission on Allied Health Personnel in Ophthalmology, Presbyopia, ACE, Inflammation, Phenylephrine, American Academy, International Joint Commission, American Academy of Ophthalmology, American Academy of Optometry, Allied health professions, Somatosensory system, Mydriasis, Pain, Pharmaceutical industry, Ophthalmology

NEW YORK, Oct. 30, 2023 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), an ophthalmic technology company commercializing Mydcombi™ for mydriasis, preparing for regulatory approval of APP130007 for relief of pain and inflammation post ocular surgery, and incorporating its advanced Optejet® device for use both in connection with its own drug-device therapeutic product candidates for presbyopia and pediatric progressive myopia as well as out-licensing for additional indications, today announced that it is sponsoring a course during the International Joint Commission on Allied Health Personnel in Ophthalmology (IJCAHPO) 51st Annual Continuing Education (ACE) program, which is being held November 3-5 in San Francisco.

Key Points: 
  • The course, Topical Pharmaceutical Drug Delivery Innovations: The Potential Role for the New Ophthalmic Spray, will offer ophthalmic technicians background on Eyenovia’s Optejet dispensing technology and training on the use of Mydcombi in daily practice.
  • “We continue to ramp our internal manufacturing capabilities, staff our sales management team and obtain additional key state licenses of which we now have eight either completed or in process.
  • We look forward to transitioning to a broader commercial launch of Mydcombi in early 2024.”
    Topical Pharmaceutical Drug Delivery Innovations: The Potential Role for the New Ophthalmic Spray
    Francis Mah, M.D., Director of Cornea and External Disease and the Co-Director, Refractive Surgery at Scripps Clinic.
  • In addition, Mydcombi was featured in a white paper on Touch Ophthalmology, Pharmacologic Mydriasis and Cycloplegia: A Review of Novel Delivery Devices, which can be accessed here .

Viatris and Ocuphire Pharma Announce FDA Approval of RYZUMVl™ (Phentolamine Ophthalmic Solution) 0.75% Eye Drops for the Treatment of Pharmacologically-Induced Mydriasis Produced by Adrenergic Agonists (e.g., Phenylephrine) or Parasympatholytic (e.g., Tro

Retrieved on: 
Wednesday, September 27, 2023
Conjunctivitis, Interim, Dysgeusia, The First Half of My Life, Light, Tropicamide, MBA, Comprehensive, Tropicamide/hydroxyamfetamine, Mydriasis, Pain, Stinger, Patient, Combustion, MIRA, Ageing, Agonist, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Parasympatholytic, Phenylephrine, Pupil, Pharmaceutical industry, Viatris

PITTSBURGH, and FARMINGTON HILLS, Mich., Sept. 27, 2023 /PRNewswire/ -- Viatris Inc. (NASDAQ: VTRS), a global healthcare company, and Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing small-molecule therapies for the treatment of retinal and refractive eye disorders, today announced that the U.S. Food and Drug Administration (FDA) has approved RYZUMVI™ (phentolamine ophthalmic solution) 0.75% for the treatment of pharmacologically-induced mydriasis produced by adrenergic agonists (e.g., phenylephrine) or parasympatholytic (e.g., tropicamide) agents.  RYZUMVl is expected to be commercially available in the U.S. in the first half of 2024.

Key Points: 
  • RYZUMVl is expected to be commercially available in the U.S. in the first half of 2024.
  • Our hope is that by addressing patient dilation barriers, we're empowering eye care professionals to broaden exam availability, leading to enhanced eye health outcomes.
  • Two drops (study eye) or one drop (fellow eye) of RYZUMVI or placebo (vehicle) were administered one hour after instillation of the mydriatic agent.
  • The efficacy of RYZUMVI was similar for all age ranges including pediatric subjects aged 3 to 17 years.

Ocuphire Pharma and Viatris Announce FDA Approval of RYZUMVI™ (Phentolamine Ophthalmic Solution) 0.75% Eye Drops for the Treatment of Pharmacologically-Induced Mydriasis Produced by Adrenergic Agonists (e.g., Phenylephrine) or Parasympatholytic (e.g., Tro

Retrieved on: 
Wednesday, September 27, 2023
Conjunctivitis, Interim, Dysgeusia, Viatris, Light, Hope, Tropicamide, MBA, Tropicamide/hydroxyamfetamine, Mydriasis, OCUP, Pain, Stinger, Patient, Combustion, MIRA, Ageing, Agonist, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Parasympatholytic, Phenylephrine, Pupil, Pharmaceutical industry

RYZUMVI is expected to be commercially available in the U.S. in the first half of 2024.

Key Points: 
  • RYZUMVI is expected to be commercially available in the U.S. in the first half of 2024.
  • Our hope is that by addressing patient dilation barriers, we’re empowering eye care professionals to broaden exam availability, leading to enhanced eye health outcomes.
  • Two drops (study eye) or one drop (fellow eye) of RYZUMVI or placebo (vehicle) were administered one hour after instillation of the mydriatic agent.
  • The efficacy of RYZUMVI was similar for all age ranges including pediatric subjects aged 3 to 17 years.

Eyenovia Acquires U.S. Commercial Rights to APP13007 (Clobetasol Propionate Ophthalmic Nanosuspension, 0.05%) from Formosa Pharmaceuticals

Retrieved on: 
Wednesday, August 16, 2023
Pharma, Partnership, Complementarity, Presbyopia, Eye, NDA, Ophthalmology, Tropicamide, Inflammation, Sale, Mydriasis, Pain, Clobetasol, Geography of Taiwan, Acquisition, Patient, PDUFA, Particle size, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Phenylephrine, Pharmaceutical industry

NEW YORK, Aug. 16, 2023 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), an ophthalmic technology company commercializing Mydcombi™ (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5% for mydriasis and developing the Optejet® device for use both in connection with its own drug-device therapeutic product candidates for presbyopia and pediatric progressive myopia as well as out-licensing for additional indications, today announced that it has entered into an agreement with Taiwan-based Formosa Pharmaceuticals (TWO:6838) whereby Eyenovia has acquired the exclusive U.S. rights to distribute and sell APP13007 (clobetasol propionate ophthalmic nanosuspension, 0.05%), which is currently under review by the U.S. Food and Drug Administration (FDA). The agency has assigned a Prescription Drug User Fee Act (PDUFA) action date for APP13007 of March 4, 2024.

Key Points: 
  • The agency has assigned a Prescription Drug User Fee Act (PDUFA) action date for APP13007 of March 4, 2024.
  • Additionally, Formosa will be eligible for payments related to the attainment of sales milestones by Eyenovia.
  • “We are pleased to have entered into this agreement with our development partner, Formosa Pharmaceuticals, to acquire the U.S. commercial rights to APP13007.
  • This agreement ushers in an exciting new chapter in Eyenovia’s emergence as a commercial ophthalmic company,” Mr. Rowe concluded.

Eyenovia Reports Second Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Thursday, August 10, 2023
Hypersensitivity, Blood pressure, Contact, Pallor, Central nervous system, Allergy, Mydriasis, Presbyopia, Cholinergic, Abnormal psychology, Tropicamide, Optometry, Pilocarpine, CNS, Sale, Tachycardia, Hypertonia, Intraocular pressure, Vomiting, ET, Photophobia, Russell, Patient, Physician, Psychotic Reaction, PDUFA, Nausea, Research, FDA, Headache, Visual acuity, Carbachol, Mouth, Cryptocurrency, Pharmaceutical industry, Property management, Medical device, Video game, Telescopic sight

NEW YORK, Aug. 10, 2023 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), an ophthalmic technology company commercializing Mydcombi™ (tropicamide+phenylephrine ophthalmic spray) for mydriasis and developing the Optejet® device for use both in connection with its own drug-device therapeutic product candidates for presbyopia and pediatric progressive myopia as well as out-licensing for additional indications, today announced its financial and operating results for the second quarter ended June 30, 2023.

Key Points: 
  • Advanced its pre-NDA presbyopia program, Apersure (Microline), and anticipates commencing the manufacture of registration batches in the fourth quarter of 2023.
  • Research and development expenses totaled approximately $2.8 million for the second quarter of 2023 as compared to $3.6 million for the second quarter of 2022.
  • For the second quarter of 2023, general and administrative expenses were approximately $3.1 million, compared to $3.5 million for the second quarter of 2022.
  • Total operating expenses for the second quarter of 2023 were approximately $6.0 million compared to $7.1 million for the second quarter of 2022.