Azura Ophthalmics Announces Primary Endpoints Met in Phase 2 Trial of Investigational Treatment for Contact Lens Discomfort
Azura Ophthalmics announced topline results from a phase 2 clinical trial evaluating the company’s investigational therapy for the treatment of contact lens discomfort (CLD). The ECLIPTIC study examining Azura’s lead asset, AZR-MD-001, met its primary endpoints by showing statistically significant improvements in multiple measures of Meibomian gland secretion and patients’ ability to wear contact lenses as desired. Full data from the study will be submitted for presentation at an upcoming scientific meeting.
The ECLIPTIC study is a single-center, single-masked, vehicle-controlled, randomized, parallel group study that evaluated the safety, tolerability and pharmacodynamics of AZR-MD-001 in 26 patients with CLD at The University of New South Wales. Primary endpoints included the assessment of meibum gland secretion score (MGS), number of Meibomian glands yielding liquid secretion (MGYLS), Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8), and comfortable wear time. The study compared twice-weekly therapy with a 1.0% dose of AZR-MD-001 to vehicle.
Topline results from the ECLIPTIC study demonstrated significant improvements in MGS with AZR-MD-001 1.0% after 14 days of treatment (Mean ± SE; 3.4 (1.64), P < 0.05). The MGS continued to improve until the study was completed (14.3 (3.05), p < 0001). There were no clinically significant differences in MGS in the vehicle treated group. Additionally, AZR-MD-001 1.0% reached statistical superiority over vehicle after 1.5 months of treatment and beyond. Similar trends were observed with MGYLS, which also reached statistical superiority over vehicle after 1.5 months of treatment and beyond. In patients treated with AZR-MD-001 1.0%, there were significant improvements reported in their contact lens comfort as early as month 1.
“We are excited by the results of the ECLIPTIC study, which validate the potential of our dermatological approach and suggest that ophthalmic keratolytics could be an effective treatment option for the millions of patients who experience contact lens discomfort,” Marc Gleason, CEO of Azura, said in a company news release. “Azura is committed to bringing the first medicine indicated for the treatment of contact lens discomfort to market – and to help us reach this goal, we plan to convene an expert panel in 2021 with leading specialists from around the world. We look forward to sharing the full data next year and advancing AZR-MD-001 through a registration study.”
Azura’s novel, lead medicine in development, AZR-MD-001, leverages SeS2 (Selenium Disulfide) as the active ingredient to treat CLD. AZR-MD-001 is a topical ointment applied to the lower lid designed to address abnormal hyperkeratinization—the build-up and shedding of the proteins at the opening of the Meibomian gland or within the gland itself—known to be the root cause of MGD. MGD is one of the most common causes of CLD, a condition known to impact more than 20 million adults in the U.S. alone.1,2,3
“These findings demonstrate the potential clinical benefits of the innovative medicines Azura is developing, the role abnormal keratin protein aggregation plays within the meibum and how this translates into the pathology we see in these clinical conditions,” Dr. Fiona Stapleton, Scientia Professor, School of Optometry and Vision Science, and Associate Dean, Enterprise, Faculty of Science, at The University of New South Wales, who initiated the study, said in the news release. “There is a significant need for a novel treatment approach for contact lens discomfort and related conditions. A therapeutic that can restore the normal flow of Meibomian gland secretions has the potential to benefit a broad population of patients, and could change how we approach the treatment of ocular surface disease.”
References
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5Nichols, J. J., Willcox, M. D., Bron, A. J., Belmonte, C., Ciolino, J. B., Craig, J. P., Dogru, M., Foulks, G. N., Jones, L., Nelson, J. D., Nichols, K. K., Purslow, C., Schaumberg, D. A., Stapleton, F., Sullivan, D. A., & members of the TFOS International Workshop on Contact Lens Discomfort (2013). The TFOS International Workshop on Contact Lens Discomfort: executive summary. Investigative ophthalmology & visual science, 54(11), TFOS7–TFOS13. https://doi.org/10.1167/iovs.13-13212