CARLSBAD, Calif., Aug. 31, 2021 /PRNewswire/ — AxeroVision declared good effects from a section 2 investigational treatment of AXR-270, the company’s novel, proprietary, when-day by day glucocorticoid product, in patients with indications and signs and symptoms of dry eye condition (DED) related with meibomian gland dysfunction (MGD).
In the multicenter period 2 demo, 129 topics had been randomized 1:1:1 to double-masked, once-each day therapy with AXR-270 .2% product (reduced dose), AXR-270 2% cream (higher dose), or car for 3 weeks. Incidence of ocular and systemic adverse functions at Day 22 was analyzed as the most important consequence evaluate, and the data showed that equally AXR-270 .2% and 2% had an excellent security profile and ended up well-tolerated.
“AXR-270 .2% cream developed clinically meaningful improvements from baseline for all scientific signs and symptoms assessed in the scientific trial,” said Houman Hemmati, MD, PhD, head of scientific growth at AxeroVision.
Endpoints exploring the efficacy of AXR-270 .2% for bettering the symptoms and signs and symptoms of DED confirmed it was involved with statistically considerable advancements from baseline to Working day 22 in Eye Dryness Rating (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.
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.
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SOURCE AxeroVision, Inc.