Parasympatholytic

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.

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.

Ocuphire Pharma Announces Submission of New Drug Application to FDA for Nyxol® Eye Drops for Reversal of Mydriasis

Retrieved on: 
Tuesday, December 6, 2022
Acquisition, Ophthalmology, MIRA, Pupil, Partnership, NVD, Food, FDA, Light, OCUP, Maintenance, Sept, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Tropicamide, Risk, DR, DME, Diabetic retinopathy, Phenylephrine, Ageing, NDA, Growth, MBA, Ciliary muscle, Presbyopia, Parasympatholytic, COVID-19, Patient, Pilocarpine, Pharmaceutical industry, RM

If approved, Nyxol is expected to be the only commercially available treatment option indicated for the reversal of dilated eyes.

Key Points: 
  • If approved, Nyxol is expected to be the only commercially available treatment option indicated for the reversal of dilated eyes.
  • If Nyxol is approved for RM in the US, Ocuphire is eligible to receive a $10 million milestone payment.
  • Nyxol is being developed for reversal of pharmacologically-induced mydriasis (RM), presbyopia, and night (or dim light) vision disturbances (NVD) under the 505(b)(2) pathway.
  • All forward-looking statements contained in this press release speak only as of the date on which they were made.