New Peer-Reviewed Data Highlight the Benefits of XHANCE in Chronic Rhinosinusitis Patients with or without Prior Sinus Surgery

YARDLEY, Pa., Sept. 05, 2024 (GLOBE NEWSWIRE) -- (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today announced the peer-review publication of a paper titled, “EDS-FLU efficacy in patients with chronic rhinosinusitis with or without prior sinus surgery in ReOpen1 and ReOpen2 randomized controlled trials”¹ in the , the journal of the American Rhinologic Society.

As discussed in the publication, the inability of topical medications to reach the region of the sinus cavities is a potential reason for lack of efficacy in chronic rhinosinusitis (CRS), particularly the common type without nasal polyps. This is different from rhinitis, which is effectively treated by standard-delivery topical medication, and also different from treating nasal polyps, which can sometimes extend down into areas reached by standard-delivery nasal sprays.

One purpose of endoscopic sinus surgery (ESS) is to enable delivery of medications into the sinus cavities. The Exhalation Delivery System™ with fluticasone (EDS-FLU; XHANCE (fluticasone propionate) nasal spray) creates unique biomechanics during use that enables deposition of corticosteroid into sinuses and sinus drainage pathways and is proven effective for treatment of chronic sinusitis (also called chronic rhinosinusitis without nasal polyps). However, it was not known if the efficacy of this novel approach was different in patients with operated versus unoperated sinuses. Two 24-week randomized trials (ReOpen1 and ReOpen2) evaluated XHANCE versus EDS-placebo in patients with CRS and were analyzed for the groups of patients with and without prior sinus surgery.

In these trials, XHANCE improved symptoms, sinus opacification, and quality of life in both groups of CRS patients either with or without prior sinus surgery, indicating that previous surgery is not required for patients with CRS to experience the benefits of treatment with XHANCE and that XHANCE can be helpful for patients even after surgery.

About Optinose

Optinose is a specialty pharmaceutical company focused on serving the needs of patients cared for by ear, nose and throat (ENT) and allergy specialists. To learn more, please visit  or follow us on and .

About XHANCE

XHANCE is a drug-device combination product that uses the Exhalation Delivery System™ (also known as the EDS®) designed to deliver a topical steroid to the high and deep regions of the nasal cavity where sinuses ventilate and drain. XHANCE is approved by the U.S. Food and Drug Administration for both the treatment of chronic rhinosinusitis without nasal polyps (also called chronic sinusitis) and chronic rhinosinusitis with nasal polyps (also called nasal polyps) in patients 18 years of age or older.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS: Hypersensitivity to any ingredient in XHANCE.

WARNINGS AND PRECAUTIONS:

• Local nasal adverse reactions, including epistaxis, erosion, ulceration, septal perforation, Candida albicans infection, and impaired wound healing, can occur. Monitor patients periodically for signs of possible changes on the nasal mucosa. Avoid use in patients with recent nasal ulcerations, nasal surgery, or nasal trauma until healing has occurred.
• Glaucoma and cataracts may occur with long-term use. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use XHANCE long-term.
• Hypersensitivity reactions (e.g., anaphylaxis, angioedema, urticaria, contact dermatitis, rash, hypotension, and bronchospasm) have been reported after administration of fluticasone propionate. Discontinue XHANCE if such reactions occur.
• Immunosuppression and infections can occur, including potential increased susceptibility to or worsening of infections (e.g., existing tuberculosis; fungal, bacterial, viral, or parasitic infection; ocular herpes simplex). Use with caution in patients with these infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients.
• Hypercorticism and adrenal suppression may occur with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue XHANCE slowly.
• Assess for decrease in bone mineral density initially and periodically thereafter.

ADVERSE REACTIONS:

• Chronic rhinosinusitis without nasal polyps: The most common adverse reactions (incidence ≥3%) are epistaxis, headache, and nasopharyngitis.
• Chronic rhinosinusitis with nasal polyps: The most common adverse reactions (incidence ≥3%) are epistaxis, nasal septal ulceration, nasopharyngitis, nasal mucosal erythema, nasal mucosal ulcerations, nasal congestion, acute sinusitis, nasal septal erythema, headache, and pharyngitis.

DRUG INTERACTIONS: Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir, ketoconazole): Use not recommended. May increase risk of systemic corticosteroid effects.

USE IN SPECIFIC POPULATIONS: Hepatic impairment. Monitor patients for signs of increased drug exposure.

Please see , including Instructions for Use

References

1- Wise SK, Adappa ND, Chandra RK, et al. EDS-FLU efficacy in patients with chronic rhinosinusitis with or without prior sinus surgery in ReOpen1 and ReOpen2 randomized controlled trials. Int Forum Allergy Rhinol. 2024;1-12. [Epub ahead of print]

Cautionary Note on Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. All statements that are not historical facts are hereby identified as forward-looking statements for this purpose and include, among others, statements relating to the potential benefits of XHANCE for the treatment of chronic rhinosinusitis with and without nasal polyps; and other statements regarding the Company's future operations, prospects, objectives, and other future events. Forward-looking statements are based upon management’s current expectations and assumptions and are subject to a number of risks, uncertainties and other factors that could cause actual results and events to differ materially and adversely from those indicated by such forward-looking statements including, among others: physician and patient acceptance of XHANCE (including for its new indication); potential for varying interpretation of clinical trial results of XHANCE; and the risks, uncertainties and other factors discussed under the caption "Item 1A. Risk Factors" and elsewhere in our most recent Form 10-K and Form 10-Q filings with the Securities and Exchange Commission - which are available at . As a result, you are cautioned not to place undue reliance on any forward-looking statements. Any forward-looking statements made in this press release speak only as of the date of this press release, and the Company undertakes no obligation to update such forward-looking statements, whether as a result of new information, future developments or otherwise.

Optinose Investor Contact

Jonathan Neely



267.521.0531

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