Hypertonia

AbbVie Launches PRODUODOPA® (foslevodopa/foscarbidopa) for People Living with Advanced Parkinson's Disease in the European Union

Retrieved on: 
Tuesday, January 9, 2024

NORTH CHICAGO, Ill., Jan. 9, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced the launch of PRODUODOPA® (foslevodopa/foscarbidopa) in the European Union for the treatment of advanced Parkinson's disease with severe motor fluctuations and hyperkinesia (excessive movement) or dyskinesia (involuntary movement), and when available combinations of Parkinson's medicinal products have not given satisfactory results.1

Key Points: 
  • The VYAFUSER™ pump for the subcutaneous delivery of PRODUODOPA received Conformité Européenne (CE) Mark in November of 2023.
  • Parkinson's disease is a chronic, progressive neurodegenerative disorder affecting approximately 6.1 million people globally3 and is expected to double by 2040.
  • "This approval is an example of our unwavering commitment to this community by developing new, transformative therapeutic options for people experiencing advanced Parkinson's disease, their families, and care partners."
  • "It is vital that the Parkinson's community have more options that can help them manage their symptoms."

Eyenovia Reports Third Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Monday, November 13, 2023

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.

Eyenovia Reports Second Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Thursday, August 10, 2023

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.

Eyenovia Announces First Commercial Sale of Mydcombi™

Retrieved on: 
Thursday, August 3, 2023

NEW YORK, Aug. 03, 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 the first commercial sale of Mydcombi. Mydcombi was approved by the US Food and Drug Administration on May 8, 2023. The initial sale was to world-renowned board-certified ophthalmologist Dr. Nathan M. Radcliffe, who has become the first physician in the U.S. to incorporate Mydcombi into his daily practice.

Key Points: 
  • Mydcombi was approved by the US Food and Drug Administration on May 8, 2023.
  • The initial sale was to world-renowned board-certified ophthalmologist Dr. Nathan M. Radcliffe, who has become the first physician in the U.S. to incorporate Mydcombi into his daily practice.
  • The product should not be used in patients with known hypersensitivity to any component of the formulation.
  • To report SUSPECTED ADVERSE REACTIONS, contact Eyenovia, Inc. At 1-833-393-6684 or FDA at 1-800-FDA-1088 (www.fda.gov/medwatch)

Eyenovia Announces Addition to Russell 2000® and Russell 3000® Indexes

Retrieved on: 
Monday, June 26, 2023

Annual Russell indexes reconstitution captures the 4,000 largest US stocks as of April 28, ranking them by total market capitalization.

Key Points: 
  • Annual Russell indexes reconstitution captures the 4,000 largest US stocks as of April 28, ranking them by total market capitalization.
  • FTSE Russell determines membership for its Russell indexes primarily by objective, market capitalization rankings and style attributes.
  • “Our addition into the widely followed Russell Indexes is another important milestone reflecting the significant progress we have made in advancing our ophthalmic delivery platform,” stated Michael Rowe, chief executive officer of Eyenovia.
  • For more information on the Russell 3000® Index and the Russell indexes reconstitution, go to the “Russell Reconstitution” section on the FTSE Russell website .

Eyenovia Announces Presentation at the OCTANE Ophthalmology Tech Forum 2023

Retrieved on: 
Thursday, June 1, 2023

NEW YORK, June 01, 2023 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), an ophthalmic technology company 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 the company will be delivering a presentation at the annual OCTANE Ophthalmology Tech Forum 2023, which is being held June 8-9 in Newport Beach, CA.

Key Points: 
  • The presentation is scheduled for Friday, June 9th at 5:00 p.m. PDT.
  • “The theme of this year’s OCTANE forum, ‘Future Focused,’ will highlight recent innovations that will shape the future of ophthalmology, and we believe our novel Optejet technology will do just that,” stated Michael Rowe, chief executive officer of Eyenovia.
  • Central Nervous System Disturbances: Caution in pediatric patients where rare incidences of central nervous system disturbances have been reported.
  • To report SUSPECTED ADVERSE REACTIONS, contact Eyenovia, Inc. At 1-833-393-6684 or FDA at 1-800-FDA-1088 (www.fda.gov/medwatch)

Eyenovia Announces FDA Approval of Mydcombi™, the First Ophthalmic Spray for Mydriasis, Which Also Leverages the Company’s Proprietary Optejet® Device Platform

Retrieved on: 
Monday, May 8, 2023

NEW YORK, May 08, 2023 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), an ophthalmic technology company 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 the U.S. Food and Drug Administration (FDA) has approved Mydcombi (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5% for inducing mydriasis for diagnostic procedures and in conditions where short term pupil dilation is desired. This represents the first approved fixed dose combination of tropicamide and phenylephrine in the United States and also the first product using Eyenovia’s proprietary Optejet device to be approved by any regulatory authority.

Key Points: 
  • The product is contraindicated and should not be used in patients with known hypersensitivity to any component of the formulation.
  • We see opportunities to unlock significant opportunities in the future treatment of other ophthalmic conditions including glaucoma and dry eye.
  • Most common ocular adverse reactions include transient blurred vision, reduced visual acuity, photophobia, superficial punctate keratitis, and mild eye discomfort.
  • To report SUSPECTED ADVERSE REACTIONS, contact Eyenovia, Inc. At 1-833-393-6684 or FDA at 1-800-FDA-1088 (www.fda.gov/medwatch)

When did you have your last tetanus vaccine? A booster dose may save your life

Retrieved on: 
Tuesday, April 18, 2023

In Australia, tetanus is rare because of high vaccination coverage, with around 14 cases reported to health authorities a year.

Key Points: 
  • In Australia, tetanus is rare because of high vaccination coverage, with around 14 cases reported to health authorities a year.
  • If you have a tetanus-prone wound and there is any doubt about your tetanus immunisation status, you should receive tetanus immunoglobulin as soon as possible.
  • If you’re overseas, it could be hard and expensive to get access to both tetanus immunoglobulin and tetanus vaccine.
  • If it has been more than ten years since your last dose, ask your GP about getting a booster.

Charles River and Cure AP-4 Announce Gene Therapy Manufacturing Collaboration

Retrieved on: 
Tuesday, September 6, 2022

Charles River Laboratories International, Inc. (NYSE: CRL) and Cure AP-4 , a non-profit foundation dedicated to raising funds and awareness about Adapter-Protein 4 Hereditary Spastic Paraplegia (AP-4 HSP), today announced a manufacturing collaboration.

Key Points: 
  • Charles River Laboratories International, Inc. (NYSE: CRL) and Cure AP-4 , a non-profit foundation dedicated to raising funds and awareness about Adapter-Protein 4 Hereditary Spastic Paraplegia (AP-4 HSP), today announced a manufacturing collaboration.
  • Charles River, a contract research and development manufacturing organization (CRO/CDMO), will provide High Quality (HQ) plasmid DNA for Cure AP-4s Phase I/II gene therapy trials against AP-4 HSP.
  • In response to this, Charles River recently announced the opening of a state-of-the-art HQ plasmid manufacturing center of excellence to address these supply shortages and support the growing needs of the cell and gene therapy field.
  • Our partnership with Charles River brings us closer to accomplishing that goal and we are excited to begin manufacturing our treatment with their experienced team.

Parkinson Canada to release the first Canadian edition of essential resource for Canadians living with Parkinson's

Retrieved on: 
Thursday, July 7, 2022

In partnership with the Davis Phinney Foundation, a long-standing resource, the Every Victory Counts manual, is getting a Canadian edition.

Key Points: 
  • In partnership with the Davis Phinney Foundation, a long-standing resource, the Every Victory Counts manual, is getting a Canadian edition.
  • The different treatments available in Canada and medications approved by Health Canada while respecting that availability can differ from province to province.
  • "They've thought of everything," said Joe van Koeverden, member of the Parkinson Advisory Council and Davis Phinney Foundation Ambassador.
  • We are grateful to Parkinson Canada for taking on this big project to localize and share this resource with their community."