Chemosis

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 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

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.

Amneal Receives Approval for Difluprednate Ophthalmic Emulsion

Retrieved on: 
Friday, November 19, 2021

Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (Amneal or the Company) today announced that it has received Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (FDA) for difluprednate ophthalmic emulsion 0.05%, which is the generic version of Durezol and is used in the treatment of inflammation and pain associated with ocular surgery.

Key Points: 
  • Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (Amneal or the Company) today announced that it has received Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (FDA) for difluprednate ophthalmic emulsion 0.05%, which is the generic version of Durezol and is used in the treatment of inflammation and pain associated with ocular surgery.
  • With the approval of difluprednate, a complex ophthalmic suspension product, we continue to shift our portfolio to increasingly complex and more differentiated product areas.
  • Difluprednate Ophthalmic Emulsion, 0.05%, as with other ophthalmic corticosteroids, may result in posterior subcapsular cataract formation; increase the hazard of secondary ocular infections, and delay healing with the increase in the incidence of bleb formation.
  • Difluprednate use is contraindicated in fungal disease of ocular structures; viral diseases of the cornea and conjunctiva; and Mycobacterial infection of the eye.