Ophthalmic drug administration

Azura Ophthalmics Expands Broad Intellectual Property Portfolio to 12 U.S. and European Patents

Retrieved on: 
Wednesday, October 19, 2022

The expansion of Azuras IP portfolio to 12 U.S. and European patents, and at least 104 patents and patent applications worldwide, validates our novel approach to harness and develop first-in-class treatments that have the potential to completely change the treatment and outcomes of lid margin and ocular surface diseases, said Marc Gleeson, Chief Executive Officer of Azura Ophthalmics.

Key Points: 
  • The expansion of Azuras IP portfolio to 12 U.S. and European patents, and at least 104 patents and patent applications worldwide, validates our novel approach to harness and develop first-in-class treatments that have the potential to completely change the treatment and outcomes of lid margin and ocular surface diseases, said Marc Gleeson, Chief Executive Officer of Azura Ophthalmics.
  • Azura expects to report Phase 2b three-month topline data in the fourth quarter of 2022.
  • Azura Ophthalmics is utilizing our deep understanding of ocular surface diseases and drug development to deliver a new therapeutic class of Ophthalmic Keratolytics to treat underserved ophthalmic conditions.
  • Our internally discovered pipeline of new chemical entities allows us to develop a portfolio of first-in-class ophthalmic therapeutics for significant unmet needs.

Azura Ophthalmics Provides Update on AZR-MD-001 Phase 2 Clinical Program Targeting Meibomian Gland Dysfunction

Retrieved on: 
Wednesday, September 28, 2022

Meibomian Gland Dysfunction is the leading cause of Dry Eye Disease and Contact Lens Discomfort impacting millions of people in the U.S. alone, said Marc Gleeson, CEO of Azura Ophthalmics.

Key Points: 
  • Meibomian Gland Dysfunction is the leading cause of Dry Eye Disease and Contact Lens Discomfort impacting millions of people in the U.S. alone, said Marc Gleeson, CEO of Azura Ophthalmics.
  • Azura is currently conducting a multi-center, double-masked, vehicle-controlled Phase 2b study that will evaluate the safety and efficacy of AZR-MD-001 in patients with MGD.
  • The ongoing study builds upon previous findings from a successful Phase 2a clinical trial evaluating AZR-MD-001 in the same patient population.
  • Meibomian Gland Dysfunction (MGD) is a chronic and progressive condition associated with blockage of the meibomian glands and alteration in the quality of expressed meibum.

Azura Ophthalmics Secures Grant to Evaluate AZR-MD-001 for Improved Vision Quality Related to Contact Lens Discomfort

Retrieved on: 
Wednesday, September 7, 2022

Meibomian gland dysfunction is the primary cause of CLD and is directly implicated in the eye dryness and discomfort millions of contact lens wearers experience.

Key Points: 
  • Meibomian gland dysfunction is the primary cause of CLD and is directly implicated in the eye dryness and discomfort millions of contact lens wearers experience.
  • It is estimated there are 140 million contact lens wearers worldwide and over 44 million wearers in the U.S. alone.
  • Contact lens discomfort (CLD) is a condition where lens wearers experience pain and irritation, causing them to reduce their lens-wearing time or completely stop wearing them.
  • The TFOS International Workshop on Contact Lens Discomfort: Report of the Contact Lens Interactions With the Ocular Surface and Adnexa Subcommittee.

Global Drug Delivery Devices Market Report 2022: Featuring Key Players F. Hoffmann-La Roche, 3M Company, Pfizer & Baxter International - ResearchAndMarkets.com

Retrieved on: 
Wednesday, July 20, 2022

The "Global Drug Delivery Devices Market Report 2022" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global Drug Delivery Devices Market Report 2022" report has been added to ResearchAndMarkets.com's offering.
  • Asia Pacific was the second-largest region in the drug delivery devices market.
  • The regulatory changes related to medical devices is expected to restraint the growth of drug delivery devices market.
  • 1) By Route Of Administration: Oral Drug Delivery; Injectable Drug Delivery; Topical Drug Delivery; Ocular Drug Delivery; Pulmonary Drug Delivery; Nasal Drug Delivery; Transmucosal Drug Delivery; Implantable Drug Delivery
    2) By Patient Care Setting: Hospitals; Diagnostic Centers; Ambulatory Surgery Centers/Clinics; Home Care Settings; Other Patient Care Settings

Aldeyra Therapeutics Receives Orphan Drug Designation from the U.S. Food and Drug Administration for ADX-2191 to Treat Primary Vitreoretinal Lymphoma

Retrieved on: 
Tuesday, July 20, 2021

Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to the company for ADX-2191 (methotrexate for intravitreal injection) for the treatment of primary vitreoretinal lymphoma (PVRL).

Key Points: 
  • Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to the company for ADX-2191 (methotrexate for intravitreal injection) for the treatment of primary vitreoretinal lymphoma (PVRL).
  • PVRL is an often fatal cancer that creates unique challenges for diagnosis and treatment, stated Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra.
  • The FDAs orphan drug designation fosters an important clinical development and commercialization pathway for ADX-2191, which represents the first methotrexate preparation specifically formulated for intraocular injection.
  • Aldeyra Therapeutics is a biotechnology company developing novel immune-modulating therapies to treat ocular and systemic diseases.

Now Delivered in a Bottle, Oasis TEARS® PF PLUS Preservative-Free Lubricant Eye Drops for the Relief of Dry Eye Symptoms

Retrieved on: 
Tuesday, July 6, 2021

OASIS Medical Inc., manufacturer and distributor of SOFT PLUG brand of punctal plugs and Oasis TEARS Preservative-Free Lubricating Eye Drops is formally launching Oasis TEARS PF PLUS preservative-free lubricant eye drops delivered in a 10mL bottle for multiuse.

Key Points: 
  • OASIS Medical Inc., manufacturer and distributor of SOFT PLUG brand of punctal plugs and Oasis TEARS Preservative-Free Lubricating Eye Drops is formally launching Oasis TEARS PF PLUS preservative-free lubricant eye drops delivered in a 10mL bottle for multiuse.
  • This proprietary system keeps Oasis TEARS PF PLUS sterile for up to 90 days after opening.
  • The Oasis TEARS brand of eye drops deliver instant relief to dry eyes with its adherence and viscoadaptive qualities.
  • Currently, MY OASIS has the following solutions available for practices communities: Oasis TEARS line preservative-free lubricating eye drops, Oasis TEARS HYPOCHLOROUS eye lid and lash antimicrobial solution, Oasis REST & RELIEF Hot & Cold eye mask, Oasis TEARS VISION patent-pending dietary supplement and Oasis TEARS OMEGA3 with 3000mg of DHA and EPA.

EyePoint Pharmaceuticals Announces Completion of Enrollment of Phase 1 DAVIO Clinical Trial of EYP-1901 for the Potential Treatment of Wet AMD

Retrieved on: 
Tuesday, May 25, 2021

We are pleased to report the completion of enrollment of all three dose cohorts in our ongoing Phase 1 trial of EYP-1901, said Nancy Lurker, CEO of EyePoint Pharmaceuticals.

Key Points: 
  • We are pleased to report the completion of enrollment of all three dose cohorts in our ongoing Phase 1 trial of EYP-1901, said Nancy Lurker, CEO of EyePoint Pharmaceuticals.
  • The completion of enrollment of our Phase 1 trial continues to make us confident that the potential advantages of EYP-1901 are obvious to patients and providers.
  • The ongoing Phase 1 DAVIO trial for EYP-1901 is an open-label twelve-month dose escalation trial examining wet AMD patients who were responsive to previous anti-VEGF therapies.
  • EYP-1901 is a potential twice-yearly sustained delivery intravitreal anti-VEGF treatment for wet age-related macular degeneration, currently being studied in a Phase 1 clinical trial.

EyeGate Pharma Reports First Quarter 2021 Financial Results and Provides Business Update

Retrieved on: 
Wednesday, May 12, 2021

PP-001 has been successfully formulated as an ophthalmic eye drop for conjunctivitis and dry eye disease (\xe2\x80\x9cDED\xe2\x80\x9d).

Key Points: 
  • PP-001 has been successfully formulated as an ophthalmic eye drop for conjunctivitis and dry eye disease (\xe2\x80\x9cDED\xe2\x80\x9d).
  • The increase of $0.342 million was primarily due to increases in personnel related costs from the Panoptes acquisition, OBG manufacturing costs, and development costs for PP-001.
  • EyeGate\xe2\x80\x99s results may also be affected by factors of which EyeGate is not currently aware.
  • The forward-looking statements in this press release speak only as of the date of this press release.

UNITY Biotechnology, Inc. Reports First Quarter 2021 Financial Results and Business Updates

Retrieved on: 
Tuesday, May 11, 2021

The single intravitreal injection of UBX1325 was well tolerated and had no adverse findings that would limit advancement of UBX1325 into further clinical investigation.

Key Points: 
  • The single intravitreal injection of UBX1325 was well tolerated and had no adverse findings that would limit advancement of UBX1325 into further clinical investigation.
  • Approximately 60 patients will be enrolled in the study, randomized evenly between UBX1325 and sham-injected patients, and followed for 24 weeks post-injection.
  • In preclinical studies, UNITY has demonstrated that targeting Bcl-xL with UBX1325 preferentially eliminates senescent cells from diseased tissue while sparing healthy cells.
  • Actual results or events could differ materially from the plans, intentions, and expectations disclosed in the forward-looking statements we make.

Adverum Biotechnologies Provides Update on the INFINITY Trial Evaluating ADVM-022 in Patients with Diabetic Macular Edema

Retrieved on: 
Wednesday, April 28, 2021

As of December 2020, the INFINITY study was fully enrolled, and all patients completed dosing of the single IVT injection of ADVM-022.

Key Points: 
  • As of December 2020, the INFINITY study was fully enrolled, and all patients completed dosing of the single IVT injection of ADVM-022.
  • All patients continue to be evaluated regularly during the monitoring phase of this study.
  • Adverum is advancing the clinical development of its novel gene therapy candidate, ADVM-022, as a one-time, intravitreal injection for the treatment of patients with wet age-related macular degeneration and diabetic macular edema.
  • Adverum undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.\n'