Cover My Eyes (Pain and Heaven)

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.

Evolus Launches New Campaign Inspiring Consumers to “Switch Your Tox and Love Evolus Forever”

Retrieved on: 
Tuesday, July 19, 2022 - 1:37pm

Evolus, Inc. (NASDAQ: EOLS), a performance beauty company with a customer-centric approach focused on delivering breakthrough products, today launched its Switch Your Tox and Love Evolus Forever campaign to encourage consumers to switch their toxin to Jeuveau (prabotulinumtoxinA-xvfs), its flagship neurotoxin product.

Key Points: 
  • Evolus, Inc. (NASDAQ: EOLS), a performance beauty company with a customer-centric approach focused on delivering breakthrough products, today launched its Switch Your Tox and Love Evolus Forever campaign to encourage consumers to switch their toxin to Jeuveau (prabotulinumtoxinA-xvfs), its flagship neurotoxin product.
  • Our Switch Your Tox and Love Evolus Forever program is designed to expand adoption and increase market share of Jeuveau by providing our customers with the tools and incentives needed to engage new patients.
  • We are confident that after two treatments, consumers will see and feel the benefits of Jeuveau and will make the switch.
  • Starting today, Evolus practices can begin participating in the program through the companys digital app platform, and consumers can enroll beginning September 1 at participating locations.

Bausch + Lomb Announces Scientific Data on XIPERE® (Triamcinolone Acetonide Injectable Suspension) to be Presented During the American Society of Retina Specialists Annual Scientific Meeting

Retrieved on: 
Wednesday, July 6, 2022 - 11:59am

VAUGHAN, ON, July 6, 2022 /PRNewswire/ -- Bausch + Lomb Corporation (NYSE/TSX: BLCO) ("Bausch + Lomb"), a leading global eye health company dedicated to helping people see better to live better, today announced that five presentations highlighting data from the XIPERE® (triamcinolone acetonide injectable suspension) pivotal Phase 3 program will be presented at the American Society of Retina Specialists (ASRS) 40th annual scientific meeting, which will take place in New York from July 13-16, 2022. The presentations will include a new post-hoc analysis of the pivotal Phase 3 trial (PEACHTREE) evaluating outcomes following treatment with XIPERE® in patients with macular edema associated with chronic uveitis.

Key Points: 
  • "At this year's ASRS annual meeting, we look forward to sharing these data with retina specialists on XIPERE, which we launched commercially in March," said Christina Ackermann, president, Ophthalmic Pharmaceuticals, Bausch + Lomb.
  • Suprachoroidal triamcinolone acetonide injectable suspension for macular edema associated with uveitis: Outcomes by anatomic subtypes in PEACHTREE.
  • Efficacy of suprachoroidal triamcinolone acetonide injectable suspension in the treatment of macular edema in patients with chronic uveitis.
  • XIPERE(triamcinolone acetonide injectable suspension) for suprachoroidal use is a corticosteroid indicated for the treatment of macular edema associated with uveitis.

Vyluma and Laboratoires Théa Enter into Licensing Agreement for the Registration and Commercialization of NVK002 in Canada, Mexico, and Select South American Countries

Retrieved on: 
Tuesday, June 14, 2022 - 12:30pm

This agreement represents an expansion of the previously announced exclusive licensing agreement for the commercialization of NVK002 in Europe and other select countries.

Key Points: 
  • This agreement represents an expansion of the previously announced exclusive licensing agreement for the commercialization of NVK002 in Europe and other select countries.
  • NVK002 is a proprietary, investigational, preservative-free eye drop administered nightly and intended for slowing the progression of myopia in children ages three to 17.
  • In addition, Vyluma will be entitled to tiered royalty payments, ranging from the mid to upper teens, on net sales of NVK002 under the expanded agreement.
  • To learn more about Tha, visit https://www.laboratoires-thea.com/en
    Investor Contact for Nevakar and Vyluma:

Horizon Therapeutics plc to Highlight Data and Education on Thyroid Eye Disease (TED) at the Endocrine Society (ENDO) 2022 Annual Conference

Retrieved on: 
Thursday, June 2, 2022 - 1:00pm

ET in ENDOExpo Theater 1, titled Evolution of Thyroid Eye Disease (TED) Treatment With Teprotumumab: Translating Bench to Bedside with Terry J. Smith, M.D., Michigan Medicine Eye Plastic, Facial Cosmetic & Orbital Surgery, Kellogg Eye Center, University of Michigan Medical School.

Key Points: 
  • ET in ENDOExpo Theater 1, titled Evolution of Thyroid Eye Disease (TED) Treatment With Teprotumumab: Translating Bench to Bedside with Terry J. Smith, M.D., Michigan Medicine Eye Plastic, Facial Cosmetic & Orbital Surgery, Kellogg Eye Center, University of Michigan Medical School.
  • The event, Achieving Gold in the Co-Management of Thyroid Eye Disease (TED), will be held in The Career and Communications Center in the Exhibit Hall on Saturday, June 11 at 11 a.m.
  • Gail will also be sharing her story between 11 a.m. and 4 p.m.
  • After a harrowing two-and-a-half-year quest for answers, she was diagnosed with Graves disease in 1990, just two years before winning her first Olympic gold medal.

Kala Announces Entry into Definitive Agreement to Sell EYSUVIS® and INVELTYS® to Alcon Inc.

Retrieved on: 
Monday, May 23, 2022 - 5:01am

ARLINGTON, Mass., May 23, 2022 (GLOBE NEWSWIRE) -- Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a commercial-stage biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies for diseases of the eye, today announced that it has entered into a definitive agreement to sell its commercial portfolio and related intellectual property assets to Alcon Inc. This includes EYSUVIS, the first and only U.S. Food and Drug Administration (FDA) approved medicine for the short-term (up to two weeks) treatment of the signs and symptoms of dry eye disease, and INVELTYS, a twice-a-day corticosteroid for the treatment of post-operative inflammation and pain following ocular surgery.

Key Points: 
  • Kala plans to focus on developing KPI-012, a novel cell-free secretome therapy that has the potential to address a number of rare and severe ocular diseases.
  • Under the terms of the asset purchase agreement, Kala will receive an upfront payment of $60 million and will be eligible to receive commercial-based sales milestone payments.
  • Piper Sandler acted as the exclusive financial advisor, and Wilmer Cutler Pickering Hale and Dorr LLP served as legal counsel to Kala.
  • Kala believes INVELTYS has a favorable profile for the treatment of inflammation and pain following ocular surgery, due to its twice-a-day dosing regimen.

Santen’s Verkazia® (Cyclosporine Ophthalmic Emulsion) 0.1% Now Available for the Treatment of Vernal Keratoconjunctivitis in Children and Adults in the United States

Retrieved on: 
Monday, May 2, 2022 - 12:05pm

We are proud to make Verkazia available for all those with VKC in the United States who have lacked optimal treatment options for this condition.

Key Points: 
  • We are proud to make Verkazia available for all those with VKC in the United States who have lacked optimal treatment options for this condition.
  • In addition, having a treatment option for the rare disease VKC will strengthen our existing product portfolio for ocular surface disease in the United States.
  • Worldwide, Verkazia is available for the treatment of VKC in the United States, Canada, and select countries across Asia and Europe.
  • Verkazia (cyclosporine ophthalmic emulsion) 0.1% is indicated for the treatment of vernal keratoconjunctivitis (VKC) in children and adults.

Allergan, an AbbVie Company, to Present New Data from its Leading Portfolio of Eye Care Treatments at the 2022 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting

Retrieved on: 
Thursday, April 28, 2022 - 1:30pm

NORTH CHICAGO, Ill., April 28, 2022 /PRNewswire/ -- Allergan, an AbbVie (NYSE: ABBV) company, announced that it will present new data on VUITY™ (pilocarpine HCl ophthalmic solution) 1.25%, the first and only FDA-approved eye drop for the treatment of presbyopia (age-related blurry near vision) in adults, and DURYSTA® (bimatoprost intracameral implant), a first-of-its-kind biodegradable implant to lower eye pressure for glaucoma patients, at the 2022 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting, May 1-4 in Denver, CO.

Key Points: 
  • VUITY is an optimized formulation of pilocarpine, an established eye care therapeutic, specifically designed to treat age-related blurry near vision.
  • VUITY uses the eye's own ability to reduce pupil size and improves near and intermediate vision without compromising distance vision.
  • VUITY(pilocarpine hydrochloride ophthalmic solution) 1.25% is aprescription eye drop used to treat age-related blurry near vision (presbyopia) in adults.
  • If more than one topical eye medication is being used, the medicines must be administered at least 5 minutes apart.

Neuromyelitis Optica Linked to Antibody Exposure During Fetal Development, Feinstein Institutes Study Finds

Retrieved on: 
Wednesday, April 20, 2022 - 8:00pm

Neuromyelitis optica spectrum disorders (NMOSD) are inflammatory diseases of the central nervous system (CNS) leading to eye pain, blindness and even paralysis.

Key Points: 
  • Neuromyelitis optica spectrum disorders (NMOSD) are inflammatory diseases of the central nervous system (CNS) leading to eye pain, blindness and even paralysis.
  • View the full release here: https://www.businesswire.com/news/home/20220420006046/en/
    Dr. Lior Brimberg is co-lead author on the study of the rare condition.
  • Recognizing the presence of this particular antibody may lead to an earlier diagnosis and treatment interventions to improve pregnancy outcomes.
  • The Feinstein Institutes for Medical Research is the home of the research institutes of Northwell Health, the largest health care provider and private employer in New York State.

ValenzaBio Announces FDA Clearance of Investigational New Drug Application for VB421, an Anti-IGF-1R Monoclonal Antibody for the Treatment of Thyroid Eye Disease

Retrieved on: 
Thursday, March 31, 2022 - 9:21pm

ValenzaBio, Inc., a biopharmaceutical company developing monoclonal antibody (mAb) therapeutics for autoimmune and inflammatory indications, today announced that its investigational new drug (IND) application for its lead drug candidate, VB421, for the treatment of thyroid eye disease (TED), has been cleared by the U.S. Food and Drug Administration (FDA) for clinical evaluation.

Key Points: 
  • ValenzaBio, Inc., a biopharmaceutical company developing monoclonal antibody (mAb) therapeutics for autoimmune and inflammatory indications, today announced that its investigational new drug (IND) application for its lead drug candidate, VB421, for the treatment of thyroid eye disease (TED), has been cleared by the U.S. Food and Drug Administration (FDA) for clinical evaluation.
  • VB421 is a potential best-in-class mAb targeting IGF-1R, which plays a central role in the pathogenesis of TED.
  • VB421 binds to IGF-1R with sub-50 pM potency and possesses favorable biophysical properties that may provide a differentiated product profile relative to other anti-IGF-1R antibodies.
  • These advantages may enable a patient-friendly, rapid, and small-volume subcutaneous injection that could expand settings of care for TED patients.