Meibomian gland

Tarsus Announces Positive Topline Results from the Ersa Phase 2a Clinical Trial Evaluating TP-03 for the Treatment of Meibomian Gland Disease in Patients with Demodex Mites

Retrieved on: 
Monday, December 11, 2023

Collarette cure and lid margin erythema cure results were also statistically significant and consistent with the results of previous TP-03 studies.

Key Points: 
  • Collarette cure and lid margin erythema cure results were also statistically significant and consistent with the results of previous TP-03 studies.
  • No statistically significant differences were observed between the BID and TID treatment arms and TP-03 was well tolerated.
  • “We are encouraged by these early results, which underscore the potential of TP-03 to address the underlying cause of disease,” said Bobak Azamian, M.D., Ph.D., Chief Executive Officer and Chairman of Tarsus.
  • “We look forward to further analyzing the data from this trial and continued discussions with the U.S. Food and Drug Administration about the best path forward for TP-03 in MGD.”

Bausch + Lomb Announces the Presentation of New Data on Products and Pipeline Programs at the Association for Research in Vision and Ophthalmology Meeting

Retrieved on: 
Thursday, April 20, 2023

“Comparative Evaluation of the Attributes of a New Cohesive Ophthalmic Viscosurgical Device.” Hosten et al.

Key Points: 
  • “Comparative Evaluation of the Attributes of a New Cohesive Ophthalmic Viscosurgical Device.” Hosten et al.
  • “Early Adoption of Triamcinolone Acetonide Suprachoroidal Injection for Uveitic Macular Edema: A Physician Survey.” Chang et al.
  • “Longitudinal Analysis of In Vitro Antibiotic Resistance Among Ocular Staphylococci Collected in the ARMOR study.” Asbell et al.
  • To report SUSPECTED ADVERSE REACTIONS, contact Bausch + Lomb at 1-800-321-4576 or FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch .

Bausch + Lomb and Novaliq Announce Publication of Pivotal Phase 3 Data on NOV03 (Perfluorohexyloctane) in Ophthalmology

Retrieved on: 
Wednesday, January 4, 2023

NOV03 is being investigated to treat the signs and symptoms of dry eye disease (DED) associated with Meibomian gland dysfunction (MGD).

Key Points: 
  • NOV03 is being investigated to treat the signs and symptoms of dry eye disease (DED) associated with Meibomian gland dysfunction (MGD).
  • The U.S. Food and Drug Administration (FDA) assigned NOV03 a Prescription Drug User Fee Act (PDUFA) action date of June 28, 2023.
  • “NOV03 was specifically developed to address excess tear evaporation and alleviate the signs and symptoms of dry eye disease associated with Meibomian gland dysfunction,” said Christina Ackermann, president, Ophthalmic Pharmaceuticals, Bausch + Lomb.
  • “These findings reinforce NOV03 as a potential new treatment option that is distinct from anti-inflammatory and immunomodulatory agents.

Azura Ophthalmics Presents Positive Results from Phase 2b Clinical Trial of AZR-MD-001 in Meibomian Gland Dysfunction at Ophthalmology Innovation Summit XII

Retrieved on: 
Friday, December 9, 2022

It was a pleasure to share our exciting Phase 2b results at OIS XII, and we look forward to advancing AZR-MD-001 to a pivotal Phase 3 clinical trial for MGD in 2023.

Key Points: 
  • It was a pleasure to share our exciting Phase 2b results at OIS XII, and we look forward to advancing AZR-MD-001 to a pivotal Phase 3 clinical trial for MGD in 2023.
  • The results from Azuras Phase 2b study of AZR-MD-001 0.5% in MGD were presented during the Spotlight on Dry Eye session at OIS XII.
  • The Phase 2b trial was a multi-center, double-masked, vehicle-controlled, parallel group study that evaluated the safety and efficacy of AZR-MD-001 in 245 patients with MGD.
  • Meibomian Gland Dysfunction is a chronic and progressive condition associated with blockage of the meibomian glands and alteration in the quality of expressed meibum which can end in gland atrophy.

Azura Ophthalmics Announces Participation at Upcoming Investor Conferences

Retrieved on: 
Monday, November 21, 2022

The Azura management team will also be available for 1X1 investor meetings.

Key Points: 
  • The Azura management team will also be available for 1X1 investor meetings.
  • AZR-MD-001 is currently being studied to evaluate the safety, efficacy, and tolerability of the study drug in patients with MGD.
  • Azura expects to initiate a second pivotal multi-center clinical trial of AZR-MD-001 0.5% in 2023.
  • 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.

Azura Ophthalmics Announces Positive Results from Phase 2b Clinical Trial of AZR-MD-001 in Meibomian Gland Dysfunction

Retrieved on: 
Thursday, November 17, 2022

Azura Ophthalmics Ltd. , a clinical-stage biopharmaceutical company developing a new therapeutic class of Ophthalmic Keratolytics for ocular surface diseases, today announced positive 3-month efficacy and safety results from its Phase 2b study of AZR-MD-001 0.5% in Meibomian Gland Dysfunction (MGD).

Key Points: 
  • Azura Ophthalmics Ltd. , a clinical-stage biopharmaceutical company developing a new therapeutic class of Ophthalmic Keratolytics for ocular surface diseases, today announced positive 3-month efficacy and safety results from its Phase 2b study of AZR-MD-001 0.5% in Meibomian Gland Dysfunction (MGD).
  • We are thrilled to build upon these positive results by advancing AZR-MD-001 to a pivotal Phase 3 clinical trial for MGD in 2023.
  • I look forward to collaborating with the Azura team and my fellow scientific advisory board members to advance AZR-MD-001.
  • Meibomian Gland Dysfunction is a chronic and progressive condition associated with blockage of the meibomian glands and alteration in the quality of expressed meibum which can end in gland atrophy.

Novaliq Announces FDA Acceptance of the New Drug Application for CyclASol® for the Treatment of Dry Eye Disease

Retrieved on: 
Monday, October 24, 2022

The Agency completed the filing review of the CyclASol NDA and determined that the application is sufficiently complete to permit a substantive review.

Key Points: 
  • The Agency completed the filing review of the CyclASol NDA and determined that the application is sufficiently complete to permit a substantive review.
  • The Prescription Drug User Fee Act (PDUFA) target action date set by the FDA for announcing its decision on Novaliqs NDA after reviewing the application is June 8, 2023.
  • If approved, CyclASol would be a highly potent but comfortable anti-inflammatory therapy for patients with dry eye disease.
  • Novaliq further plans to submit a marketing authorization application to the European Medicines Agency and further authorities in 2023.

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.