ASEAN countries in sporting events

Clearside Biomedical Enters into Non-Dilutive Financing Agreement with HealthCare Royalty Partners for up to $65 Million

Retrieved on: 
Monday, August 8, 2022
Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Diabetic retinopathy, U.S. Securities and Exchange Commission, ASEAN countries in sporting events, GLOBE, Form, Private Securities Litigation Reform Act, Growth, SEC, Macular edema, LLC, Bausch & Lomb, SCS, Annual report, Patient, 8-K, COVID-19, Periodic Report of the United States of America to the United Nations Committee Against Torture, Eye, Axitinib, AMD, VEGF, TKI, Uveitis, Ophthalmology, Secretary General of the ASEAN, Nasdaq, Pharming, Retina, Squamous cell carcinoma, Food, Choroid, Pharmaceutical industry, Clearside

Under the terms of the agreement, Clearside will receive an initial payment of $32.5 million, less certain expenses.

Key Points: 
  • Under the terms of the agreement, Clearside will receive an initial payment of $32.5 million, less certain expenses.
  • The terms of the agreement also provide for an additional milestone payment of $20 million to Clearside upon attainment of a second pre-specified 2024 sales milestone for XIPERE.
  • The arrangement with HealthCare Royalty specifically excludes all Clearsides internal development programs, including CLS-AX, as well as any future in-licensed assets.
  • HEALTHCARE ROYALTY PARTNERS is a registered trademark of HealthCare Royalty Management, LLC in the U.S. and a trademark in other countries.

AffaMed Therapeutics, licensee of DEXTENZA® in Certain Asian Markets, Doses Their First Patient in Clinical Trial Evaluating the Safety and Efficacy of DEXTENZA® in China in Cataract Surgery Patients

Retrieved on: 
Tuesday, January 18, 2022
Health, Surgery, Clinical Trials, Pharmaceutical, Optical, Biotechnology, Ophthalmology, IQVIA, Patient, Eye, Inflammation, Private Securities Litigation Reform Act, Clinical trial, Dexamethasone, COVID-19, AMD, Safety, Growth, NASDAQ, ASEAN, ASEAN countries in sporting events, Axitinib, U.S. Securities and Exchange Commission, Duane syndrome, Pain, Therapy, Allergic conjunctivitis, Company, Retina, FDA, Intraocular pressure, Compliance, Security (finance), Ocular hypertension, Pharmaceutical industry, Ocular Therapeutix, Inc., AffaMed Therapeutics, DEXTENZA®, OCULAR THERAPEUTIX, INC., AFFAMED THERAPEUTICS, DEXTENZA®

In 2020, Ocular entered into a licensing agreement with AffaMed Therapeutics for the development and commercialization of DEXTENZA in Greater China, South Korea, and the ASEAN markets.

Key Points: 
  • In 2020, Ocular entered into a licensing agreement with AffaMed Therapeutics for the development and commercialization of DEXTENZA in Greater China, South Korea, and the ASEAN markets.
  • This prospective, single-arm, real-world trial is designed to assess the safety and efficacy of DEXTENZA for the treatment of ocular inflammation and pain following cataract surgery in approximately 120 patients at the Boao Super Hospital.
  • Ocular Therapeutix's first product, ReSure Sealant, is an FDA-approved device to prevent wound leaks in corneal incisions following cataract surgery.
  • DEXTENZA is FDA approved for the treatment of ocular inflammation and pain following ophthalmic surgery and ocular itching associated with allergic conjunctivitis.

Clearside Biomedical Features FDA-Approved XIPERE™ in Multiple Presentations at the American Academy of Ophthalmology 2021 and American Uveitis Society Meetings

Retrieved on: 
Tuesday, November 16, 2021
American Academy of Ophthalmology, Suprachoroidal drug delivery, Clinical trial, Particle-size distribution, SCS, Safety, Clearside, Triamcinolone, Food, Acral lentiginous melanoma, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, American Journal, Visual acuity, Macular edema, MBA, Rescue, Secretary General of the ASEAN, GLOBE, Patient, FDA, Choroid, Bausch & Lomb, BHC, NASDAQ, Eye, Diabetic retinopathy, Cataract, Sclera, American Academy, CST, AZALEA, JAMA Ophthalmology, Retina, Manuscript, Cohort, ASEAN countries in sporting events, Uveitis, AAO, MEDLINE, AMD, Incidence, Clinical, NYSE, Intravitreal injection, Physician, OCT, Animal, Pharmaceutical industry, Medical imaging

This study assessed these relationships, focusing on baseline anatomic features with potential prognostic value for visual response.

Key Points: 
  • This study assessed these relationships, focusing on baseline anatomic features with potential prognostic value for visual response.
  • This post hoc analysis of 198 eyes evaluated two Phase 3, 24-week UME clinical trials with CLS-TA (PEACHTREE and AZALEA).
  • A manuscript describing these results is in press at the American Journal of Ophthalmology, a peer-reviewed Medline-indexed journal.
  • Clearside American Uveitis Society Presentations:
    In conjunction with the AAO meeting, Clearside participated in the American Uveitis Society Fall Meeting on Sunday, November 14, 2021.

Clearside Biomedical Expands XIPERE™ License Agreement with Arctic Vision to Include Australia, New Zealand, India and ASEAN Countries

Retrieved on: 
Thursday, September 9, 2021

If approved, XIPERE will be the first therapy for macular edema associated with uveitis and will be the first approved therapeutic delivered into the suprachoroidal space.

Key Points: 
  • If approved, XIPERE will be the first therapy for macular edema associated with uveitis and will be the first approved therapeutic delivered into the suprachoroidal space.
  • XIPERE, referred to as ARVN001 by Arctic Vision, is a proprietary suspension of the corticosteroid triamcinolone acetonide formulated for administration to the suprachoroidal space (SCS) using Clearsides patented SCS Microinjector.
  • In China, Arctic Vision is planning to initiate a Phase 3 clinical trial of ARVN001 in the second half of 2021.
  • Clearside Biomedical, Inc. is a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases.