Novaliq 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 10 clinical sites in the United States. SEECASE was a phase 2, multicenter, 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 8 weeks.
The SEECASE trial met its prespecified primary endpoint, improvement of total corneal fluorescein staining over control at 8 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 2 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,” Joseph Tauber, MD, and practicing ophthalmologist at Tauber Eye Center, Kansas City, said in a company news release. “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.”