News Release

YARDLEY, Pa., Sept. 29, 2020 /PRNewswire/ -- Optinose (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, "Efficacy of the exhalation delivery system with fluticasone (EDS-FLU) in patients who remain symptomatic on standard nasal steroid sprays"¹ in the International Forum of Allergy & Rhinology, the journal of the American Rhinologic Society. EDS-FLU is U.S. Food and Drug Administration (FDA) approved for the treatment of nasal polyps in patients 18 years of age or older and is marketed under the trade name XHANCE® (fluticasone propionate) for the up to 1 in 3 patients whose chronic rhinosinusitis is complicated by nasal polyps.

First-line treatment for the 10 million patients who suffer with nasal polyps is often conventional, over the counter, inhaled steroids that were originally approved for allergic rhinitis (AR). But unlike AR, the nasal polyps associated with chronic rhinosinusitis start deep in the nasal cavity where nasal sprays usually do not reach. This analysis of data from the Phase 3 XHANCE studies showed comparable improvement across multiple outcome measures for patients receiving XHANCE, regardless of whether they were previously treated with a conventional inhaled nasal spray.

"It is very common for people suffering from symptoms of chronic rhinosinusitis, especially those with nasal polyps, to feel frustrated or experience persistent symptoms despite first-line treatment with standard conventional steroid nasal sprays," said Brent Senior, M.D., Professor of Otolaryngology and Vice Chair of Academics and Outreach at the University of North Carolina and lead author of the paper. "This analysis of pooled data from XHANCE pivotal trials finds that people who reported changing over to XHANCE from a conventional steroid nasal spray improved substantially across a range of measures, and just as much as the whole study population. This supports the value of using XHANCE to put medicine high and deep in the nose, where standard nasal sprays usually do not reach."

"Published treatment guidelines for chronic rhinosinusitis, including nasal polyps, call for treating first with inexpensive and relatively safe topically acting nasal steroids," said John Bosso, M.D., Medical Director and Clinical Associate of Allergy at the University of Pennsylvania.  "This publication is important because it shows that when first-line treatment isn't meeting the need, XHANCE is an important option that may help before a patient either gives up in frustration or feels compelled to move on to surgery or chronic use of an injectable biologic medication. This new information supports an emerging expert consensus that a stepwise care pathway for patients with chronic rhinosinusitis and nasal polyps can optimize medical therapy. Conventional nasal steroids will often be considered first, XHANCE should be considered for those who do not succeed, surgical treatment should be considered for those not succeeding with appropriate medical therapy, and eventually expensive biologics are an option for those who require it."

"We are excited to see publication of this data that supports the value of XHANCE in the continuum of care," said Ramy Mahmoud, M.D., MPH, President of Optinose. "The Optinose team is focused on identifying opportunities to help improve the standard of care for ENT and allergy patients, which includes studying ways to treat the inflammatory processes that characterize this disease."

About the Study
This post-hoc analysis explored pooled data from the previously published NAVIGATE I and NAVIGATE II trials to compare the benefit of EDS-FLU vs EDS-placebo for the 45% of patients who reported use of a standard nasal steroid spray at study entry (median treatment duration of approximately 3 years) to the overall study population. Across multiple measures, including all 4 cardinal symptoms, patients who reported use of a standard nasal steroid spray at study entry were observed to have comparable improvement to patients who did not report prior use of conventional steroid nasal sprays at study entry. 

About XHANCE (EDS-FLU)
EDS-FLU uses an Optinose Exhalation Delivery System (EDS) designed to deliver a topical anti-inflammatory corticosteroid to the high and deep regions of the nasal cavity where nasal polyps originate. Ten million patients suffer from nasal polyps which leads to approximately $5.7 billion in direct costs annually.² EDS-FLU was approved for the treatment of nasal polyps in patients 18 years of age or older by the U.S. Food and Drug Administration in September 2017 under the trade name XHANCE®.

Important Safety Information

CONTRAINDICATIONS: Hypersensitivity to any ingredient in XHANCE.

WARNINGS AND PRECAUTIONS:

• Local Nasal Effects: epistaxis, erosion, ulceration, septal perforation, Candida albicans infection, and impaired wound healing. 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.
• Close monitoring for glaucoma and cataracts is warranted.
• 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: 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.
• Patients with major risk factors for decreased bone mineral content should be monitored and treated with established standards of care.

ADVERSE REACTIONS: 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.

INDICATION AND USAGE: XHANCE is a corticosteroid indicated for the treatment of nasal polyps in patients 18 years of age or older.

About Optinose
Optinose is a global 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 www.optinose.com or follow us on Twitter and LinkedIn.

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®, the potential emerging expert consensus for a stepwise care pathway for patients with chronic rhinosinusitis and nasal polyps and the role of XHANCE in the continuum of care 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, potential for varying interpretation of clinical trial results 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 www.sec.gov. 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 we undertake no obligation to update such forward-looking statements, whether as a result of new information, future developments or otherwise.

References

1-      Senior BA, Schlosser RJ, Bosso J, Soler ZM. Efficacy of the exhalation delivery system with fluticasone in patients who remain symptomatic on standard nasal steroid sprays. Int Forum Allergy Rhinol. 2020 Sept 24. doi: 10.1002/alr.22693. [Epub ahead of print]
2-      Bhattacharyya et al. Laryngoscope. 2019;129(9):1969-1975. 

Investor Relations Contact
Jonathan Neely
jonathan.neely@optinose.com 
267-521-0531

Media Contact
Becky Kern
becky@greenroompr.com 
914-772-2310

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SOURCE Optinose