Novaliq named Finalist in “Clinical Trial Result of the Year” category of the Clinical & Research Excellence Awards CARE 2019
- Novaliq is recognized for its SEECASE clinical trial results of NOV03 demonstrating unprecedented sign and symptom improvements for Dry Eye Disease (DED) patients while offering an excellent safety profile
- NOV03 is potentially the first drug targeting the key underlying cause of evaporative DED, the leading reason for this undertreated disease that impacts visual function
Heidelberg – February 26, 2019 – Novaliq, the pharmaceutical company for the development and commercialization of first- and best-in-class ocular therapeutics based on the water-free EyeSol® technology, has been named a finalist in “Clinical Trial Result of the Year” category of the CARE Awards, which recognizes outstanding work across the global clinical research enterprise.
In 2018, Novaliq conducted the SEECASE trial which enrolled 336 patients at ten clinical sites in the United States and published topline data in October 2018. SEECASE was a phase 2, multi-center, randomized, double-masked, controlled clinical trial (NCT03333057) and was designed to evaluate the effects of two dosing regimens of NOV03 on signs and symptoms of Dry Eye Disease (DED). The trial results showed that NOV03 effectively improved both clinical signs of ocular health and patient-reported symptoms, with a fast onset of action, in patients with DED associated with MGD.
NOV03 is a potential breakthrough therapy for DED patients based on its novel mode of action. NOV03 stabilizes the lipid layer of the tear film and thereby prevents excessive tear evaporation, and also penetrates meibomian glands, potentially dissolving thickened meibum to improve meibomian gland function.It is therefore the first time that a drug addresses the underlying cause of evaporative DED.
Based on the unprecedented findings from the SEECASE trial, Novaliq has accelerated its development program to achieve regulatory approval and drug availability on the market soon. The final pivotal clinical trial is expected to start in 2019, leading to the NDA filing in 2021.
The CARE Awards 2019 features 11 categories, significant accomplishments and highlight innovation across the industry – from rare diseases drug development and patient centricity in trials and research, to product and technological development, clinical results and collaborative efforts between individuals, departments, or companies. Entries are judged independently by a panel of experts from all core sectors of the clinical R&D industry.
“We are thrilled to be selected as one of three finalists for the clinical trial results of the SEECASE trial and thus be acknowledged for the dedicated work of Novaliq’s clinical development team lead by Sonja Krösser, PhD, VP Preclinical & Clinical Development. This worldwide recognition of the trial outcomes is reflecting the high potential of NOV03 eye drops to impact the lives of many untreated patients suffering from dry eye disease and further supports Novaliq’s strategy to accelerate the last phase of development,” said Gabriela Burian MD, Consulting Chief Medical Officer at Novaliq.
The 2019 winners will be announced at a ceremony on Thursday, May 2ndat the Hyatt Regency Boston, MA, where distinguished leaders in the biopharmaceutical, CRO, and diagnostic industries gathered from all corners of the globe.
You can view the full list of finalists here: https://pharmaintelligence.informa.com/events/awards/care-awards-2019/shortlist
Bausch + Lomb and Novaliq Announce FDA Approval of MIEBOTM (Perfluorohexyloctane Ophthalmic Solution) for the Treatment of the Signs and Symptoms of Dry Eye Disease
Novaliq announces publication of second pivotal phase 3 trial data on CyclASol® 0.1% (Cyclosporine Ophthalmic Solution) in JAMA Ophthalmology
NOV03 Consistently Met Primary Endpoints for Signs and Symptoms of Dry Eye Disease Associated with Meibomian Gland Dysfunction
Bausch + Lomb and Novaliq Announce Publication of Second Pivotal Phase 3 Data on NOV03 (Perfluorohexyloctane) in American Journal of Ophthalmology NOV03 Consistently Met Primary Endpoints for Signs and Symptoms of Dry Eye Disease Associated with Meibomian Gland Dysfunction NOV03 PDUFA Action Date is June 28, 2023VAUGHAN, Ontario, and HEIDELBERG, Germany, March 22, 2023 – 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 American Journal of Ophthalmology has published results from MOJAVE, the second pivotal Phase 3 trial for NOV03 (perfluorohexyloctane). NOV03 is being investigated to treat the signs and symptoms of dry eye disease (DED) associated with Meibomian gland dysfunction (MGD). Results from the first pivotal Phase 3 trial, GOBI, were published earlier this year in Ophthalmology. The U.S. Food and Drug Administration (FDA) assigned NOV03 a Prescription Drug User Fee Act (PDUFA) action date of June 28, 2023.