Atropine

Zhaoke Ophthalmology Completed Patient Enrollments for the Phase III Clinical Trials of the Myopia Progression Treatment Drug NVK002

Retrieved on: 
Wednesday, August 3, 2022 - 2:16am

The primary objective of the China CHAMP and Mini-CHAMP trials is to evaluate the efficacy and safety of NVK002 for the treatment of myopia progression in children and adolescents.

Key Points: 
  • The primary objective of the China CHAMP and Mini-CHAMP trials is to evaluate the efficacy and safety of NVK002 for the treatment of myopia progression in children and adolescents.
  • These early completions of patient recruitment across both trials, gives the company a strong headstart in moving towards its goal to lead the market in launching a myopia progression treatment drug.
  • Following this, a New Drug Application ("NDA") submission to the US Food and Drug Administration (the "FDA") is expected in 2023.
  • Dr. Li Xiaoyi (Benjamin), Chairman of the Board of Directors, Executive Director and CEO of Zhaoke Ophthalmology, said, "The early completion of the patient recruitment of NVK002's Phase III clinical trials marks another huge and exciting milestone for Zhaoke Ophthalmology.

U.S. Department of Defense Awards $5.1 Million to Humanetics Corporation for Continued Development of Radiation Countermeasure

Retrieved on: 
Tuesday, June 21, 2022 - 3:36pm

Minneapolis-based Humanetics Corporation (Humanetics) has entered into a new $5.1 million cooperative research agreement with the U.S. Department of Defense (DOD) to continue advanced development of BIO 300, a medical countermeasure to protect military personnel and first responders from the harm caused by radiation exposure.

Key Points: 
  • Minneapolis-based Humanetics Corporation (Humanetics) has entered into a new $5.1 million cooperative research agreement with the U.S. Department of Defense (DOD) to continue advanced development of BIO 300, a medical countermeasure to protect military personnel and first responders from the harm caused by radiation exposure.
  • Auto injectors are commonly used by the military to deliver fast-acting drugs such as atropine and naloxone.
  • The drug was licensed to Humanetics Corporation, which is leading its advanced development toward FDA approval.
  • We are enthused and encouraged by the DODs continued investment in the development of BIO 300 as a medical countermeasure, said Zenk.

Eton Pharmaceuticals and XGen Pharmaceuticals DJB Announce Commercial Launch of Rezipres® (ephedrine hydrochloride), a Ready-to-Use Formulation of Injectable Ephedrine (4.7 mg/mL)

Retrieved on: 
Monday, March 14, 2022 - 11:00am

DEER PARK, Ill., March 14, 2022 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc. (Nasdaq: ETON) and XGen Pharmaceuticals DJB, Inc. today announced the commercial availability of Rezipres (ephedrine hydrochloride) injection.

Key Points: 
  • DEER PARK, Ill., March 14, 2022 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc. (Nasdaq: ETON) and XGen Pharmaceuticals DJB, Inc. today announced the commercial availability of Rezipres (ephedrine hydrochloride) injection.
  • Rezipres (4.7 mg/mL) is a ready-to-use1 formulation of injectable ephedrine hydrochloride that is approved for the treatment of clinically important hypotension occurring in the setting of anesthesia.
  • We look forward to partnering with XGen DJB given their extensive track record of successfully commercializing injectable products in the hospital setting, said Sean Brynjelsen, CEO of Eton Pharmaceuticals.
  • We are delighted to be teaming up with Eton as the commercial partner in introducing their ready-to-use Rezipres product, which is the first FDA-approved hydrochloride-based ephedrine injectable formulation, added Edmund Vanderbeck, President of XGen Pharmaceuticals DJB.

Amneal Expands Injectables Portfolio with 4 New Products

Retrieved on: 
Thursday, February 17, 2022 - 1:00pm

Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (Amneal or the Company) today announced the approval of four generic injectables products.

Key Points: 
  • Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (Amneal or the Company) today announced the approval of four generic injectables products.
  • An important element of Amneals long-term growth strategy is expanding our injectables business, and todays announcement of four new approvals is another key step.
  • The Company has a diverse portfolio of approximately 250 products in its Generics segment and is expanding across a broad range of complex products and therapeutic areas, including injectables and biosimilars.
  • In its Specialty segment, Amneal has a growing portfolio of branded pharmaceutical products focused primarily on central nervous system and endocrine disorders, with a pipeline focused on unmet needs.

Luminopia Announces FDA Approval of Digital Therapeutic that Uses TV Shows to Improve Vision in Children with Lazy Eye

Retrieved on: 
Wednesday, October 20, 2021 - 5:32pm

Luminopia One allows patients to watch therapeutically modified TV shows and movies to improve their vision within a virtual reality (VR) headset.

Key Points: 
  • Luminopia One allows patients to watch therapeutically modified TV shows and movies to improve their vision within a virtual reality (VR) headset.
  • The FDA approval of a new digital therapy with robust clinical evidence for children affected by amblyopia is a major development.
  • The idea of prescribing TV shows and movies to treat amblyopia in children instead of eye patches or eye drops is an exciting prospect.
  • Luminopia One is the first FDA-approved digital therapeutic for a neuro-visual disorder in children, indicated to improve vision in children with amblyopia.

Luminopia One, a Digital Therapeutic for Amblyopia, Demonstrates Safety and Efficacy in Phase 3 Pivotal Trial

Retrieved on: 
Tuesday, September 14, 2021 - 1:00pm

The published study was a Phase 3 multicenter, randomized controlled clinical trial designed to evaluate the safety and efficacy of Luminopia One to treat amblyopia in children aged 4-7.

Key Points: 
  • The published study was a Phase 3 multicenter, randomized controlled clinical trial designed to evaluate the safety and efficacy of Luminopia One to treat amblyopia in children aged 4-7.
  • A link to the publication, Randomized Controlled Trial of a Dichoptic Digital Therapeutic for Amblyopia, can be found here: https://www.aaojournal.org/article/S0161-6420(21)00682-5/fulltext .
  • Luminopia One has been validated in multiple clinical trials, including a Phase 3 pivotal trial that demonstrated its safety and efficacy in children aged 4-7 for the treatment of amblyopia.
  • Luminopia is committed to creating digital therapeutics that are both rigorously evaluated for FDA approval and genuinely engaging for patients.

Vyluma Inc. Launches With Robust Opthalmic Portfolio, Leading With A Pharmaceutical Treatment In Phase III For Myopia

Retrieved on: 
Tuesday, May 25, 2021 - 12:00pm

The robust pipeline of novel therapies is led by NVK002, a pharmaceutical atropine eyedrop to slow the progression of myopia in children.

Key Points: 
  • The robust pipeline of novel therapies is led by NVK002, a pharmaceutical atropine eyedrop to slow the progression of myopia in children.
  • NVK002 is currently in late Phase III CHAMP clinical trial in the United States and Europe, and Phase II in Asia.
  • If NVK002 stays on its current timeline it would potentially be the first approved treatment for myopia using atropine eyedrops to slow the progression of pediatric myopia, in the world.
  • Vyluma has a total of five pharmaceutical assets in its pipeline to address unmet treatment needs in the eyecare market.

HJF Receives Patent for Potential Treatment for Nerve Agent Exposure

Retrieved on: 
Tuesday, May 11, 2021 - 2:30pm

b"BETHESDA, Md., May 11, 2021 /PRNewswire/ --The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. (HJF) received notice of allowance for a patent from the United States Patent Office (USPO) for a medical countermeasure to organophosphate (OP) nerve agent exposure.

Key Points: 
  • b"BETHESDA, Md., May 11, 2021 /PRNewswire/ --The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. (HJF) received notice of allowance for a patent from the United States Patent Office (USPO) for a medical countermeasure to organophosphate (OP) nerve agent exposure.
  • The therapy was shown to be effective even with delayed use following nerve agent exposure.
  • Currently, treatment for OP exposure is with an anticholinergic agent administered immediately after exposure; thus, military personnel may receive kits containing atropine auto-injectors for use in the event of a nerve-gas attack.\nDr.
  • Importantly, this new combination therapy also extends the therapeutic window, as it is effective even when administered hours after OP exposure.

Zhaoke Ophthalmology Announced First Patient Completes Three Year Enrollment in Phase III CHAMP Study of NVK-002

Retrieved on: 
Thursday, November 12, 2020 - 6:38am

HONG KONG, Nov. 12, 2020 /PRNewswire/ --Zhaoke (Hong Kong) Ophthalmology Pharmaceutical Ltd. ("Zhaoke Hong Kong") is pleased to announce today that the first patient has completed three year enrollment in the Phase III CHAMP (Childhood Atropine for Myopia Progression) study carried out by its partner, Nevakar Inc.("Nevakar").

Key Points: 
  • HONG KONG, Nov. 12, 2020 /PRNewswire/ --Zhaoke (Hong Kong) Ophthalmology Pharmaceutical Ltd. ("Zhaoke Hong Kong") is pleased to announce today that the first patient has completed three year enrollment in the Phase III CHAMP (Childhood Atropine for Myopia Progression) study carried out by its partner, Nevakar Inc.("Nevakar").
  • It is currently under clinical evaluation in the CHAMP study and has entered Phase 3 clinical trial in the US and Europe.
  • CHAMP is a 576 subject, randomized, placebo-controlled, double-masked study evaluating the effects of NVK-002 on myopia progression in children.
  • Zhaoke (Hong Kong) Ophthalmology Pharmaceutical Ltd. is a wholly owned subsidiary of Zhaoke Ophthalmology Limited ("Zhaoke Ophthalmology"), which specializes in the development, manufacturing and marketing of ophthalmic drugs.

Bausch Health Licenses Eyenovia's Investigational Treatment For The Reduction Of Pediatric Myopia Progression In Children Ages 3-12

Retrieved on: 
Monday, October 12, 2020 - 12:00pm

"If approved, this product could potentially change the treatment paradigm for the reduction of myopia progression in children ages 3-12, thus helping to fulfill a significant unmet medical need."

Key Points: 
  • "If approved, this product could potentially change the treatment paradigm for the reduction of myopia progression in children ages 3-12, thus helping to fulfill a significant unmet medical need."
  • Atropine ophthalmic solution is Eyenovia's investigational, potentially first-in-class topical treatment for the reduction of pediatric myopia progression, also known as nearsightedness, in children ages 3-12.
  • Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc., is solely focused on helping people see.
  • Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global company whose mission is to improve people's lives with our health care products.