Benzinga | Jan 19, 2021 07:09AM EST

Bausch + Lomb Completes Enrollment Of First Phase 3 Study For NOV03

Phase 2 Study Published in Cornea: The Journal of Cornea and External Disease; Study Met Primary Endpoint in Patients with Highly Symptomatic Evaporative Dry Eye Disease Associated with Meibomian Gland Dysfunction

LAVAL, QC and HEIDELBERG, Germany, Jan. 19, 2021 /PRNewswire/ -- Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc. (TSX:BHC) ("Bausch Health" or the "Company"), and Novaliq GmbH, a pharmaceutical company focusing on first- and best-in-class ocular therapeutics, today announced the first of two Phase 3 studies evaluating NOV03 as a first-in-class investigational drug with a novel mechanism of action to treat the signs and symptoms of Dry eye disease (DED) associated with Meibomian gland dysfunction (MGD) has been completely enrolled with a total of 599 participants.

Additionally, a Phase 2 clinical study (SEECASE) evaluating the efficacy, safety, and tolerability of NOV03 (perfluorohexyloctane) ophthalmic solution in patients with DED associated with MGD has been published in Cornea: The Journal of Cornea and External Disease. In the study, NOV03 met its primary efficacy endpoint of statistically significant improvement of total corneal fluorescein staining over control at eight weeks. NOV03 also showed statistically significant improvement of certain symptoms, such as severity and frequency of dryness and burning/stinging of the eyes, over the entire duration of the Phase 2 study.1

"We are committed to addressing the unmet needs of patients, and believe NOV03, if approved, may be a first-in-class treatment option for the millions of patients who suffer from Dry eye disease associated with Meibomian gland dysfunction," said Joseph C. Papa, chairman and CEO, Bausch Health. "This continued progress in our Phase 3 program and the published results of the SEECASE study are both exciting milestones in our development journey for NOV03."

"Dry eye disease is one of the most common ocular surface disorders causing discomfort for millions of Americans," said Joseph Tauber, M.D., founder of Tauber Eye Center in Kansas City, Mo., and lead author of the publication. "Given the key role Meibomian gland dysfunction plays in the pathogenesis of this disease, we are very encouraged by the findings in the SEECASE study, which demonstrate the potential for NOV03 as a possible treatment for those with highly symptomatic DED associated with MGD, and look forward to the results of the Phase 3 studies."

Summary of Phase 2 SEECASE Study Results

The prospective, multicenter, randomized, double-masked, saline-controlled clinical study evaluated NOV03 at two dosing regimens. The data published was based on results from 336 patients age 18 years or older who were randomized to one of four treatment groups: NOV03 four times daily (QID), NOV03 twice daily (BID), saline BID or saline QID (a 2:2:1:1 ratio). The study met its primary efficacy endpoint of statistically significant improvement of total corneal fluorescein staining (tCFS) over control at eight weeks. Data showed a change from baseline of tCFS over control, for both dosing regimens (QID and BID, P < 0.001 and P = 0.009, respectively). Effects on tCFS and symptoms started at two weeks after start of treatment and were maintained over the study duration. The effects were dosing schedule dependent. NOV03 was well tolerated with instillation site reactions below 3% in both treatment regimens.1

The SEECASE study was conducted at 12 ophthalmology practices in the United States with patients who had a history of DED in both eyes and if one eye (the same eye) met the inclusion criteria at screening and at randomization time. Several symptom assessments such as Eye Dryness Score measured using visual analog scale (VAS), VAS for other symptoms such as burning/stinging, itching, blurred vision, and sensitivity to light, and Ocular Surface Disease Index (OSDI) were evaluated to assess the effect of NOV03 on DED symptomatology.1

Patients treated with NOV03 also experienced statistically significant improvement of certain DED symptoms over the entire duration of the Phase 2 study. Changes from baseline were statistically significant compared with those of the control group at week eight [P < 0.001 (QID) and P = 0.002 (BID)]. Other symptoms evaluated included burning/stinging, sticky feeling, foreign body sensation, itching, blurred vision, sensitivity to light and pain. The following treatment emergent adverse events (TEAEs) reported by more than 2% of subjects were blurred vision in the NOV03 QID group, eye irritation in the NOV03 BID group and eye pain in the saline group. Overall the number of patients reporting at least one TEAE was similar between the treatment groups.1

"The results demonstrated in the SEECASE study support NOV03 as a potential new treatment option for patients with DED associated with MGD, and we look forward to learning the results from both of the Phase 3 studies," said Christian Roesky, Ph.D., CEO, Novaliq GmbH.

About NOV03 (perfluorohexyloctane) Ophthalmic Solution

NOV03 is an investigational, proprietary, water-free and preservative-free solution, based on patented EyeSol(r) technology from Novaliq GmbH.2 In 2019, Bausch Health and Bausch + Lomb acquired an exclusive license for the commercialization and development of NOV03 in the United States and Canada, and together, they announced in November 2020 that they have initiated the second of two Phase 3 studies to evaluate NOV03.