Year: 2022

FDA accepts NDA filing for NOV03

VAUGHAN, Ontario, and HEIDELBERG, Germany, Sept. 6, 2022 – Bausch + Lomb Corporation (NYSE/TSX: BLCO) (“Bausch + Lomb”), a leading global eye health company dedicated to helping people see better to live better, and Novaliq GmbH, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) filing for investigational treatment NOV03 (perfluorohexyloctane). A potential first-in-class eye drop with a novel mechanism of action, NOV03 is an investigational therapy to treat the signs and symptoms of dry eye disease (DED) associated with Meibomian gland dysfunction (MGD). NOV03 has been assigned a Prescription Drug User Fee Act (PDUFA) action date of June 28, 2023.

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Dermaliq Therapeutics Announces First Patient Dosed in Phase 1b/2 Trial Evaluating DLQ02 for Treatment of Plaque Psoriasis

Wilmington, Delaware, August 18, 2022 – Dermaliq Therapeutics, Inc. (Dermaliq), a private, clinical stage pharmaceutical company with a focus on dermatology, today announced first patient dosed in a Phase 1b/2a trial with DLQ02, a topical calcineurin inhibitor. The trial is designed to evaluate the safety, systemic absorption, pharmacodynamics, and clinical efficacy of DLQ02 in patients with plaque psoriasis.

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Novaliq submits New Drug Application seeking approval for first-of-a-kind Dry Eye Disease Treatment CyclASol®

Heidelberg, Germany, and Cambridge, MA, USA, August 09, 2022 – Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol® water-free technology, today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for CyclASol® (cyclosporine ophthalmic solution), a proposed novel treatment for the signs and symptoms of dry eye disease (DED).

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Bausch + Lomb and Novaliq Announce Submission of New Drug Application for Investigational Treatment NOV03 (Perfluorohexyloctane)

VAUGHAN, Ontario, and HEIDELBERG, Germany, July 7, 2022 – Bausch + Lomb Corporation (NYSE/TSX: BLCO) (“Bausch + Lomb”), a leading global eye health company dedicated to helping people see better to live better, and Novaliq GmbH, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics, today announced the submission of a New Drug Application (NDA) at the end of June to the U.S. Food and Drug Administration (FDA) seeking approval for NOV03 (perfluorohexyloctane), an investigational treatment with a proposed indication of treating the signs and symptoms of dry eye disease (DED) associated with Meibomian gland dysfunction (MGD).

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Novaliq Presents Data from Second Phase 3 Trial of Investigational Treatment CyclASol® at ASCRS Annual Meeting

Heidelberg, Germany, and Cambridge, MA, USA, April 26, 2022 – Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol® water-free technology, today announced that data from the second pivotal Phase 3 trial (ESSENCE-2) evaluating the investigational drug CyclASol® for the treatment of dry eye disease (DED), was presented as part of a podium symposium at the American Cataract and Refractive Surgery (ASCRS) annual meeting in Washington D.C. on April 24, 2022.

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Bausch + Lomb Presents Data from First Pivotal Phase 3 Trial of Investigational Treatment NOV03 at ASCRS Annual Meeting

VAUGHAN, ON and LAVAL, QC and HEIDELBERG, Germany, April 25, 2022 /PRNewswire/ — Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc. (NYSE/TSX: BHC) (“Bausch Health”), and Novaliq GmbH, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics, today announced that data from the first pivotal Phase 3 trial (GOBI) of NOV03 (perfluorohexyloctane), which is being investigated as a first-in-class eye drop with a novel mechanism of action to treat the signs and symptoms of dry eye disease (DED) associated with Meibomian gland dysfunction (MGD), was presented yesterday as part of a podium presentation on April 24, 2022, at the American Society of Cataract and Refractive Surgery (ASCRS) annual meeting in Washington, D.C.

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Dermaliq Therapeutics Signs USD 15 Million Series A Round to Advance Three Transformative Drug Therapies into the Clinics

  • Dermaliq Therapeutics, Inc. is an independent private pharmaceutical company emerged from Novaliq
  • Spin-off to unlock value in the space of medical dermatology by using Novaliq’s transformative technology outside eye care
  • 3E Bioventures Capital and Beijing Whale Technology Corporation Ltd join as new investors
  • Proceeds will be used for three Phase 1/2a clinical development programs in dermatology

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