Heidelberg, Germany –Oct 24, 2018 – Novaliq, a specialty pharmaceutical company for the development and commercialization of first- and best-in-class ocular therapeutics based on EyeSol®, the worldwide first water-free technology for ophthalmology, today announces positive topline results for its SEECASE phase 2 clinical trial of NOV03 for the treatment of dry eye disease (DED) in more than 300 patients.
NOV03 (100% perfluorohexyloctane) is a preservative-free ophthalmic solution and the first drug developed to treat evaporative DED associated with meibomian gland dysfunction (MGD). Patients suffering from DED with imbalanced tear conditions due to significant MGD represent a symptomatic and large population with high medical needs in today’s clinical care.
Currently, the treatment options for these patients are limited. NOV03 uniquely treats DED associated with MGD based on novel modes of action that complementary balance the tear condition: it stabilizes the lipid layer for several hours, thereby preventing excessive evaporation, and it has the potential to penetrate the meibomian glands, to improve meibum quality, and to enhance the function of the meibomian gland.
Since January 2018, Novaliq has conducted the SEECASE phase 2 clinical trial which enrolled 336 patients at ten clinical sites in the United States. SEECASE was a phase 2, multi-center, randomized, double-masked, saline-controlled clinical trial (NCT03333057) and was designed to evaluate the effects of NOV03 at two different dosing regimens on signs and symptoms of DED. SEECASE evaluated its primary efficacy at eight weeks.
The SEECASE trial met its prespecified primary endpoint, improvement of total corneal fluorescein staining over control at eight weeks, with high statistical significance for both dosing regimens QID and BID (p<0.001 and p=0.009, respectively). The effect started as early as two weeks after start of treatment and was maintained over the entire duration of the trial for both treatment regimens. In addition, NOV03 showed pronounced and highly statistically significant improvement in various symptoms over control, again consistent over the entire duration of the trial. The magnitude of effect in symptoms is on average up to 50% improvement from baseline depending on the parameter and thus highly relevant for DED patients.
“I am impressed by the strong data of the SEECASE trial. The simultaneous demonstration of improvement in symptoms and robust improvement in ocular surface signs stands out as among the most convincing data in a dry eye study that I have seen,” said Joseph Tauber, MD, and practicing ophthalmologist at Tauber Eye Center, Kansas City, MO. “A treatment that could effectively relieve the symptoms of many patients with DED associated with meibomian gland dysfunction, for which there are currently poor treatment options, would be a very welcome addition to our clinical practice.“
The study showed an excellent safety and tolerability profile for NOV03 and thus provides robust data to support its development as a first treatment targeting patients with predominantly evaporative DED associated with MGD.
“We are very pleased with the outcomes of the SEECASE study showing unprecedented sign and symptom improvements for patients with evaporative DED associated with MGD,” says Sonja Krösser, PhD, VP Clinical Development at Novaliq. “We look forward to discussing our data with the FDA and to agreeing on next steps to timely complete the clinical development of NOV03.“
Details of the topline results of SEECASE will be presented for the first time by Novaliq’s CEO, Christian Roesky, during the Ophthalmology Innovation Summit (OIS) on October 25th, 2018 in Chicago, USA. For further information, please send an email to event@novaliq.com.
Sources:
1. Craig et al., TFOS DEWS II Definition and Classification Report. Ocul Surf 2017, 15:276-283.
2. Ocular Drug Delivery Report, MCD Group, July 2017.
3. Lemp et al.; Cornea 2012, 31: 472–8.
4. Bron et al.; Ocul Surf 2004, 2:149-164.
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, 2023
VAUGHAN, 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.Heidelberg, Germany, and Cambridge, MA, USA, Feb 8, 2023 – Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol® water-free technology, today announced its plans for filing a Marketing Authorisation Application (MAA) for CyclASol® (ciclosporin ophthalmic solution), a first-of-its-kind anti-inflammatory product for the treatment of dry eye disease (DED) in the European Union.