Focal neurologic signs

Lecanemab named one of the world's best inventions in 2023 by TIME

Retrieved on: 
Tuesday, October 24, 2023
Risk, Aneurysm, Vomiting, Cerebral edema, Focal neurologic signs, Incidence, Dementia, Nausea, Disease, Intraparenchymal hemorrhage, Intracerebral hemorrhage, CET, Chills, AI, Paracetamol, Hypersensitivity, Memory, Lecanemab, Vascular malformation, MRI, Excipient, Neuroimaging, Fatal, Thought, Dizziness, Aspirin, Edema, Anticoagulant, Cerebral amyloid angiopathy, Magnetic resonance imaging, Patient, Bronchospasm, Alzheimer's disease, Anaphylaxis, Genetic testing, TIME, ARIA, Arthralgia, Research, Eisai, Fever, Hypotension, Amyloid, Headache, Siderosis, Behavior, Invention, Observation, Hypertension, Confusion, Seizure, Angioedema, Status epilepticus, Tissue plasminogen activator, Pharmaceutical industry, Lace, Medical imaging, Copper

"It is a great honor and tremendous recognition that lecanemab is included in TIME's list of the world's best inventions this year.

Key Points: 
  • "It is a great honor and tremendous recognition that lecanemab is included in TIME's list of the world's best inventions this year.
  • TIME's annual list of the best inventions includes "200 extraordinary innovations changing lives."
  • The information was released for public disclosure, through the agency of the contact persons below, on October 24, 2023, at 4.50 p.m. CET.
  • ARIA usually occurs early in treatment and is usually asymptomatic, although serious and life-threatening events rarely can occur.

LEQEMBI® Intravenous Infusion (Lecanemab) Approved for the Treatment of Alzheimer’s Disease in Japan

Retrieved on: 
Monday, September 25, 2023
Hypersensitivity, Status epilepticus, Intracerebral hemorrhage, Cerebral amyloid angiopathy, Arthralgia, Cerebral edema, Hypotension, Aneurysm, Risk, Focal neurologic signs, Chills, Fatal, Fever, Edema, Neuroimaging, AND, Angioedema, Siderosis, Tissue plasminogen activator, Aspirin, Hypertension, Vomiting, Incidence, Excipient, ARIA, Anticoagulant, MRI, Magnetic resonance imaging, Dizziness, Amyloid, Patient, Intraparenchymal hemorrhage, Anaphylaxis, Paracetamol, Seizure, Genetic testing, Confusion, Nausea, Observation, Lecanemab, Headache, Bronchospasm, Vascular malformation, Medical device, Pharmaceutical industry, Lace, Medical imaging, Copper

INDICATION, DOSAGE AND ADMINISTRATION, AND IMPORTANT SAFETY INFORMATION IN THE U.S.

Key Points: 
  • INDICATION, DOSAGE AND ADMINISTRATION, AND IMPORTANT SAFETY INFORMATION IN THE U.S.
    LEQEMBI is indicated for the treatment of Alzheimer’s disease.
  • Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.
  • ARIA usually occurs early in treatment and is usually asymptomatic, although serious and life-threatening events rarely can occur.
  • Testing for ApoE ε4 status should be performed prior to initiation of treatment to inform the risk of developing ARIA.

RVL Pharmaceuticals plc to Discuss Second Quarter 2023 Financial Results and Provide Commercial Update

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Wednesday, August 2, 2023
Blood pressure, Glaucoma, Blepharoplasty, Ptosis, Orthostatic hypotension, Hypotension, Conference call, Focal neurologic signs, Stroke, Cardiovascular disease, Eye, Orbit, Myasthenia gravis, Beta blocker, Hypertension, Telecanthus, Ophthalmoparesis, Metabolism, Patient, Xanthine oxidase inhibitor, Risk, Eye injury, Glycosidic bond, System, Aneurysm, Headache, Conference, Horner's syndrome, Phosphorus, Pharmaceutical industry

UPNEEQ® (oxymetazoline hydrochloride ophthalmic solution), 0.1% is indicated for the treatment of acquired blepharoptosis in adults.

Key Points: 
  • UPNEEQ® (oxymetazoline hydrochloride ophthalmic solution), 0.1% is indicated for the treatment of acquired blepharoptosis in adults.
  • Ptosis may be associated with neurologic or orbital diseases such as stroke and/or cerebral aneurysm, Horner syndrome, myasthenia gravis, external ophthalmoplegia, orbital infection and orbital masses.
  • Consideration should be given to these conditions in the presence of ptosis with decreased levator muscle function and/or other neurologic signs.
  • Caution is advised in patients taking monoamine oxidase inhibitors which can affect the metabolism and uptake of circulating amines.

RVL Pharmaceuticals plc to Discuss First Quarter 2023 Financial Results and Provide Commercial Update

Retrieved on: 
Thursday, May 4, 2023
Blood pressure, Glaucoma, Blepharoplasty, Ptosis, Orthostatic hypotension, Hypotension, Focal neurologic signs, Stroke, Cardiovascular disease, Eye, Orbit, Myasthenia gravis, Beta blocker, Hypertension, Telecanthus, Ophthalmoparesis, Metabolism, Patient, Xanthine oxidase inhibitor, Risk, Eye injury, Glycosidic bond, System, Aneurysm, Headache, Horner's syndrome, Phosphorus, Pharmaceutical industry

Ptosis may be associated with neurologic or orbital diseases such as stroke and/or cerebral aneurysm, Horner syndrome, myasthenia gravis, external ophthalmoplegia, orbital infection and orbital masses.

Key Points: 
  • Ptosis may be associated with neurologic or orbital diseases such as stroke and/or cerebral aneurysm, Horner syndrome, myasthenia gravis, external ophthalmoplegia, orbital infection and orbital masses.
  • Consideration should be given to these conditions in the presence of ptosis with decreased levator muscle function and/or other neurologic signs.
  • Advise UPNEEQ patients with cardiovascular disease, orthostatic hypotension, and/or uncontrolled hypertension or hypotension to seek medical care if their condition worsens.
  • Caution is advised in patients taking monoamine oxidase inhibitors which can affect the metabolism and uptake of circulating amines.

RVL Pharmaceuticals plc to Discuss Fourth Quarter and Full Year 2022 Financial Results and Provide Commercial Update

Retrieved on: 
Wednesday, March 15, 2023
Ophthalmoparesis, Conference, Myasthenia gravis, Hypotension, Glaucoma, Eye, International, Patient, Blood pressure, Horner's syndrome, Risk, URL, Telecanthus, Focal neurologic signs, Aneurysm, Hypertension, Metabolism, Beta blocker, Orthostatic hypotension, Ptosis, Eye injury, Glycosidic bond, Blepharoplasty, Cardiovascular disease, ID, Conference call, Headache, System, Orbit, Stroke, Xanthine oxidase inhibitor, Phosphorus, Pharmaceutical industry

UPNEEQ® (oxymetazoline hydrochloride ophthalmic solution), 0.1% is indicated for the treatment of acquired blepharoptosis in adults.

Key Points: 
  • UPNEEQ® (oxymetazoline hydrochloride ophthalmic solution), 0.1% is indicated for the treatment of acquired blepharoptosis in adults.
  • Consideration should be given to these conditions in the presence of ptosis with decreased levator muscle function and/or other neurologic signs.
  • Advise UPNEEQ patients with cardiovascular disease, orthostatic hypotension, and/or uncontrolled hypertension or hypotension to seek medical care if their condition worsens.
  • Caution is advised in patients taking monoamine oxidase inhibitors which can affect the metabolism and uptake of circulating amines.

RVL Pharmaceuticals plc Announces Preliminary Fourth Quarter Sequential Growth of 21% and Full Year 2022 UPNEEQ® Net Product Sales

Retrieved on: 
Monday, January 9, 2023
Cardiovascular disease, Security (finance), Xanthine oxidase inhibitor, Hypertension, Orthostatic hypotension, Aneurysm, Eye injury, Glycosidic bond, Focal neurologic signs, Headache, Blood pressure, FDA, Risk, Food and Drug Administration, Ptosis, Hypotension, Glaucoma, Telehealth, Orbit, Blepharoplasty, Marketing, Patient, Food, Growth, Annual report, Metabolism, Horner's syndrome, Duane syndrome, Ophthalmoparesis, Stroke, RVL, Beta blocker, Nature, Eye, Myasthenia gravis, Pharmaceutical industry, Phosphorus

BRIDGEWATER, N.J., Jan. 09, 2023 (GLOBE NEWSWIRE) -- RVL Pharmaceuticals plc (Nasdaq: RVLP) (“RVL” or the “Company”), a specialty pharmaceutical company, today announced preliminary fourth quarter and full year 2022 net product sales of UPNEEQ® (oxymetazoline hydrochloride ophthalmic solution), 0.1%, the first and only U.S. Food and Drug Administration (“FDA”)-approved ophthalmic solution for blepharoptosis, or droopy eyelids, of approximately $12.1 million and $36.5 million, respectively. The preliminary fourth quarter 2022 net product sales of UPNEEQ represent a sequential increase of 21% from the third quarter 2022. The Company also announced that from February through year-end 2022 it had received orders from approximately 4,300 cumulative unique medical aesthetics practices.

Key Points: 
  • The preliminary fourth quarter 2022 net product sales of UPNEEQ represent a sequential increase of 21% from the third quarter 2022.
  • “We are proud of our progress in the fourth quarter, notably the continued upward trajectory of net product sales for UPNEEQ.
  • On a full-year basis, we expect our UPNEEQ revenues to exceed $36 million, representing nearly 400% growth over 2021.
  • The financial and operating data for the fourth quarter of 2022 and for the full year 2022 is preliminary and may change.

EISAI SUBMITS MARKETING AUTHORIZATION APPLICATION FOR LECANEMAB AS TREATMENT FOR EARLY ALZHEIMER'S DISEASE IN EUROPE

Retrieved on: 
Tuesday, January 10, 2023
Cerebral edema, Intracerebral hemorrhage, Anticoagulant, Arthralgia, Aspirin, Stroke, MRI, Dizziness, Cerebral contusion, Seizure, Hypotension, Effectiveness, Status epilepticus, Diarrhea, Clopidogrel, Alzheimer's disease, Aneurysm, Risk, Vomiting, ARIA, Chills, AND, Disease, Nausea, Patient, Intracranial hemorrhage, Vascular malformation, Cough, Paracetamol, Hypertension, Focal neurologic signs, Headache, Observation, Incidence, Tissue plasminogen activator, Confusion, Siderosis, Fever, Medical device, Pharmaceutical industry, Medical imaging, Clothing

Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.

Key Points: 
  • Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.
  • There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied.
  • Depending on ARIA severity, use clinical judgment in considering whether to continue dosing, temporarily discontinue treatment, or permanently discontinue LEQEMBI.
  • In Study 1, 15% of LEQEMBI-treated patients, compared to 6% of placebo-treated patients, stopped study treatment because of an adverse reaction.

RVL Pharmaceuticals plc to Present at the Cantor Medical & Aesthetic Dermatology, Ophthalmology & MedTech/Diagnostic Conference

Retrieved on: 
Thursday, December 1, 2022
Hypertension, Patient, Stroke, Orbit, Duane syndrome, Headache, Glycosidic bond, Glaucoma, Orthostatic hypotension, Risk, Cardiovascular disease, Myasthenia gravis, Horner's syndrome, Aneurysm, Beta blocker, Blood pressure, Hypotension, Focal neurologic signs, Ptosis, Eye injury, Xanthine oxidase inhibitor, Ophthalmoparesis, Eye, Metabolism, Blepharoplasty, Phosphorus, Pharmaceutical industry

Consideration should be given to these conditions in the presence of ptosis with decreased levator muscle function and/or other neurologic signs.

Key Points: 
  • Consideration should be given to these conditions in the presence of ptosis with decreased levator muscle function and/or other neurologic signs.
  • Advise UPNEEQ patients with cardiovascular disease, orthostatic hypotension, and/or uncontrolled hypertension or hypotension to seek medical care if their condition worsens.
  • Advise patients to seek medical care if signs and symptoms of potentiation of vascular insufficiency develop.
  • Caution is advised in patients taking monoamine oxidase inhibitors which can affect the metabolism and uptake of circulating amines.

RVL Pharmaceuticals plc to Discuss Third Quarter 2022 Financial Results and Provide Commercial Update

Retrieved on: 
Thursday, November 3, 2022
Patient, Ptosis, Blood pressure, Beta blocker, Glycosidic bond, Duane syndrome, Focal neurologic signs, International, Glaucoma, Hypotension, Eye injury, FDA, Hypertension, Blepharoplasty, Stroke, Xanthine oxidase inhibitor, ID, Horner's syndrome, Cardiovascular disease, Orthostatic hypotension, Risk, URL, Metabolism, Ophthalmoparesis, Headache, Orbit, Myasthenia gravis, Eye, Aneurysm, Phosphorus, Pharmaceutical industry

UPNEEQ (oxymetazoline hydrochloride ophthalmic solution), 0.1% is indicated for the treatment of acquired blepharoptosis in adults.

Key Points: 
  • UPNEEQ (oxymetazoline hydrochloride ophthalmic solution), 0.1% is indicated for the treatment of acquired blepharoptosis in adults.
  • Ptosis may be associated with neurologic or orbital diseases such as stroke and/or cerebral aneurysm, Horner syndrome, myasthenia gravis, external ophthalmoplegia, orbital infection and orbital masses.
  • Consideration should be given to these conditions in the presence of ptosis with decreased levator muscle function and/or other neurologic signs.
  • RVL Pharmaceuticals plc is a specialty pharmaceutical company focused on the commercialization of UPNEEQ (oxymetazoline hydrochloride ophthalmic solution), 0.1%, for the treatment of acquired blepharoptosis, or low-lying eyelid, in adults.

RVL Pharmaceuticals plc Announces Preliminary Third Quarter 2022 UPNEEQ® Net Product Sales

Retrieved on: 
Tuesday, October 18, 2022
U.S. Securities and Exchange Commission, Hypertension, Cardiovascular disease, Risk, Mission statement, RVL, Growth, Orthostatic hypotension, Stroke, Focal neurologic signs, Glycosidic bond, Horner's syndrome, Ptosis, Annual report, Patient, Beta blocker, Duane syndrome, Security (finance), Blood pressure, Nasdaq, Myasthenia gravis, Eye, Glaucoma, Xanthine oxidase inhibitor, Food, Company, Blepharoplasty, Food and Drug Administration, Marketing, Ophthalmoparesis, Headache, Eye injury, Nature, GLOBE, Metabolism, Hypotension, Terminology, FDA, Aneurysm, Orbit, Video game, Pharmaceutical industry, Phosphorus

BRIDGEWATER, N.J., Oct. 18, 2022 (GLOBE NEWSWIRE) -- RVL Pharmaceuticals plc (Nasdaq: RVLP) (“RVL” or the “Company”), a specialty pharmaceutical company, today announced preliminary third quarter 2022 net product sales of UPNEEQ® (oxymetazoline hydrochloride ophthalmic solution), 0.1%, the first and only U.S. Food and Drug Administration (“FDA”)-approved ophthalmic solution for blepharoptosis, or droopy eyelids, of approximately $10.0 million. The Company also announced that from February through September of 2022 it had received orders from approximately 3,500 cumulative unique medical aesthetics practices. RVL further revised its guidance for net product sales of UPNEEQ for the fourth quarter of 2022, indicating an expectation of $12 to $14 million, representing sequential growth of 20% to 40% compared to the third quarter of 2022.

Key Points: 
  • --Expects third quarter 2022 preliminary UPNEEQ net product sales of approximately $10.0 million, representing an increase of 19% over the second quarter 2022--
    --Third quarter 2022 net product sales growth contributed to approximately $24.4 million in sales for the nine months ended September 30, 2022--
    --Approximately 3,500 cumulative unique medical aesthetics practices placed orders for UPNEEQ through the end of the third quarter 2022, a 59% increase from the end of the second quarter 2022--
    --Anticipates fourth quarter 2022 UPNEEQ net product sales to grow approximately 20% - 40% over the third quarter 2022, representing sales of approximately $12 - $14 million--
    BRIDGEWATER, N.J., Oct. 18, 2022 (GLOBE NEWSWIRE) -- RVL Pharmaceuticals plc (Nasdaq: RVLP) (RVL or the Company), a specialty pharmaceutical company, today announced preliminary third quarter 2022 net product sales of UPNEEQ (oxymetazoline hydrochloride ophthalmic solution), 0.1%, the first and only U.S. Food and Drug Administration (FDA)-approved ophthalmic solution for blepharoptosis, or droopy eyelids, of approximately $10.0 million.
  • RVL further revised its guidance for net product sales of UPNEEQ for the fourth quarter of 2022, indicating an expectation of $12 to $14 million, representing sequential growth of 20% to 40% compared to the third quarter of 2022.
  • The financial and operating data for the third quarter of 2022 is preliminary and may change.
  • In addition, the Companys estimate of UPNEEQ net product sales for the third quarter of 2022 should not be viewed as a substitute for full financial statements for the third quarter of 2022 prepared in accordance with U.S. generally accepted accounting standards.