AxeroVision, Inc. Announces Phase 2 Results for AXR-270 for Treatment of Dry Eye Disease Associated With MGD
CARLSBAD, Calif., Aug. 31, 2021 /PRNewswire/ -- AxeroVision announced positive results from a phase 2 investigational treatment of AXR-270, the company's novel, proprietary, once-daily glucocorticoid cream, in patients with signs and symptoms of dry eye disease (DED) associated with meibomian gland dysfunction (MGD).
In the multicenter phase 2 trial, 129 subjects were randomized 1:1:1 to double-masked, once-daily treatment with AXR-270 0.2% cream (low dose), AXR-270 2% cream (high dose), or vehicle for 3 weeks. Incidence of ocular and systemic adverse events at Day 22 was analyzed as the primary outcome measure, and the data showed that both AXR-270 0.2% and 2% had an excellent safety profile and were well-tolerated.
"AXR-270 0.2% cream produced clinically meaningful improvements from baseline for all clinical signs and symptoms assessed in the clinical trial," said Houman Hemmati, MD, PhD, head of clinical development at AxeroVision.
Endpoints exploring the efficacy of AXR-270 0.2% for improving the signs and symptoms of DED showed it was associated with statistically significant improvements from baseline to Day 22 in Eye Dryness Score (EDrS; P<.001), Eye Discomfort Score (EDiS; P<.001), tear breakup time (TBUT; P<.01), and total corneal fluorescein staining (tCFS; P<.001). Superiority of AXR-270 0.2% cream versus vehicle was achieved for some measures (P<.05), and it demonstrated rapid onset of benefit. Among patients treated with AXR-270 0.2% cream, statistically significant improvement from baseline was seen for both EDrS (P<.001) and EDiS (P<.001) as well as tCFS (P<.05) at Day 8, which was the first follow-up visit, and for TBUT by Day 14 (P<.05).
"We have decided to pursue our first indication for AXR-270 in dry eye disease," said Achim Krauss, PhD, CEO and president of AxeroVision. "After meeting with the FDA on June 30, 2021 for further clarification we are confident with this path forward and look forward to initiating our phase 3 trial in Q1 of 2022."
"Results from the phase 2 study showed statistically and clinically meaningful improvement in both a sign and symptom of dry eye disease associated with MGD," said Stephen C. Pflugfelder, MD, professor and James and Margaret Elkins Chair in Ophthalmology, Baylor College of Medicine and scientific advisor to AxeroVision. "The encouraging results on AXR-270 may provide clinicians with a viable once-daily topical treatment option devoid of the accompanying side effects commonly seen with other topical steroids."
Based on the results of the phase 2 study, AxeroVision plans to enroll a total of approximately 800 patients in its phase 3 trials comparing AXR-270 0.2% cream with vehicle in the first quarter of 2022, with an NDA/MAA filing for AXR-270 anticipated in 2024.
About AXR-270
AXR-270 is a highly potent, pharmacologically differentiated selective glucocorticoid receptor agonist (SeGRA) with a unique gene transactivation and transrepression profile. It is formulated in a proprietary cream intended for application to the eyelids that provides enhanced periorbital drug delivery. Data from preclinical studies demonstrated greater and more prolonged exposure with AXR-270 formulated in the cream vehicle than with topical drop delivery, supporting a once-daily treatment regimen for AXR-270 cream.
About AxeroVision, Inc.
AxeroVision is a privately held clinical stage biotech company founded in 2016 as a spinout of GlaxoSmithKline (GSK). AxeroVision's mission is to develop drugs for the treatment of dry eye disease and other ophthalmic inflammatory diseases. The company boasts a nimble, highly experienced team with 200+ years of combined experience in ophthalmic drug development. For more information visit www.axerovision.com.
About Dry Eye Disease
Dry eye disease is a common condition and a leading cause of patient visits to eye care providers. Meibomian gland dysfunction is considered the leading cause of DED, although DED is recognized to be a multifactorial disease with numerous possible etiologies.
Dry eye disease occurs because the tear film is unstable and is unable to provide adequate lubrication and protection for the surface of the eye. Tear film deficiency, which may be due to insufficient tear volume and/or poor tear quality, causes tear film instability that leads to inflammation. Inflammation results in damage to the eye's surface that perpetuates tear film instability and leads to progression of DED. Inflammation together with tear film instability results in bothersome symptoms that include visual disturbance, stinging, burning, and general discomfort. Medications that address inflammation, including corticosteroids, are recommended in management algorithms for DED.
SOURCE AxeroVision, Inc.
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