Steroid-Releasing S8 Sinus Implant for Recurrent Nasal Polyps

RESOLVE is a randomized (1:1), sham-controlled, parallel group, double-blind multicenter
study in 100 chronic sinusitis patients who had prior endoscopic sinus surgery and presented
with recurrent nasal polyps. The objective of the study was to assess the safety and efficacy
of the S8 Sinus Implant, a steroid-eluting sinus implant, consisting of a bioabsorbable
self-expanding sinus implant coated with 1350 mcg of mometasone furoate (MF) and a single-use
delivery system. Implant is placed in-office in the ethmoid sinus under local anesthesia. The
coating on the S8 implant provides controlled release of MF to the sinus mucosa over 90 days,
with the majority of drug released within 60 days.

Inclusion Criteria

Candidates for this study had to meet ALL of the following inclusion criteria:

1. General Inclusion Criteria

1. Patient has provided written informed consent using a form approved by the reviewing
IRB.

2. Patient is ≥ 18 years of age.

3. Patient is willing and able to comply with protocol requirements.

4. Patient has a previous confirmed diagnosis of CS defined as inflammation of the mucosa
of the paranasal sinuses.

5. Patient has undergone bilateral total ethmoidectomy (must be at least 90 day beyond
the date of last sinus surgery).

6. Patient has recurrent bilateral sinus obstruction due to polyposis (Grades 1 through 3
only).

7. Patient must have a Grade 2 polyposis on at least 1 ethmoid side.

8. Patient is able to tolerate the use of Nasonex topical intranasal steroid spray once
daily.

9. Patient is indicated for a repeat ESS per the study definition. Patient must have: (i)
a minimum symptom burden on the SNOT 22, consisting of a minimum score of 2 on at
least 2 of the 5 hallmark symptoms of CS (nasal blockage, post-nasal discharge, thick
nasal discharge, facial pain/pressure, and decreased sense of smell); (ii) persistent
symptoms of CS despite ongoing treatment with topical intranasal steroid irrigations
or sprays at least once daily for at least 2 weeks preceding enrollment; (iii) had
treatment with a high-dose form of steroids (e.g., oral, parenteral, injection into
polyps) and/or sinus steroid irrigations within the preceding 2 years, or refused such
therapy due to intolerance/side effects; (iv) a known history of repeated courses of
treatment with aggressive steroid therapy for recurrent sinusitis; and (v) endoscopic
evidence of polyp recurrence, scarring, and/or obstructive mucosal edema.

10. Patient is able to tolerate use of topical/local anesthesia and the implant procedure
in an office or clinic setting.

11. In the opinion of the physician, treatment with S8 Sinus Implant or sham procedure is
technically feasible (able to pass 5-9 mm device into middle meatus) bilaterally.

12. Female patients of child-bearing potential must not be pregnant and must agree to not
become pregnant during the course of the study.

13. Female patients of child-bearing potential must agree to use consistent and acceptable
method/s of birth control during the course of the study.

Exclusion Criteria

Candidates were excluded if they met ANY of the following criteria:

General Exclusion Criteria

1. Patient had bilateral total ethmoidectomy less than 90 days previously.

2. Patient had Propel implanted postoperatively less than 90 days previously.

3. Patient has presence of adhesions/synechiae Grades 3 or 4.

4. Patient has presence of severe scarring or adhesions within the ethmoid cavity itself.

5. Patient has presence of Grade 4 polyposis.

6. Patient has known history of immune deficiency (e.g., IGG] subclass deficiency or IGA
deficiency, HIV).

7. Patient has concurrent condition requiring active chemotherapy and/or immunotherapy
management for the disease (e.g., cancer, HIV, etc.).

8. Patient has oral-steroid dependent condition such as chronic obstructive pulmonary
disease (COPD), asthma or other condition.

9. Patient has known history of allergy or intolerance to corticosteroids or mometasone
furoate (MF).

10. Patient has known history of resistance or poor response to oral steroids.

11. Patient has presence of physical obstruction that would preclude access to either
ethmoid sinus for device delivery (e.g., severe septal deviation, septal spur, very
small middle meatus, total obstruction of the nasal passage with severe scarring,
polyposis).

12. Patient has clinical evidence of acute bacterial sinusitis (e.g., acute increase in
purulent discharge, fever, facial pain etc.).

13. Patient has clinical evidence or suspicion of invasive fungal sinusitis (e.g., bone
erosion on prior CT scan, necrotic sinus tissue, etc.).

14. Patient has evidence of disease or condition expected to compromise survival or
ability to complete follow-up assessments during the 6 month follow-up period.

15. Patient is currently participating in or recently participated in another clinical
trial (within the last 30 days).

16. Patient has history of insulin dependent diabetes mellitus.

17. Patient has previously undergone ESS and experienced a CSF leak or has residual
compromised vision as a result of a complication in a prior ESS procedure.

18. Patient has completely resected middle turbinate.

19. Patient has known dehiscence of the lamina papyracea.

20. Patient has evidence of active viral illness (e.g., tuberculosis, ocular herpes
simplex, chickenpox, or measles).

Ocular Exclusion Criteria

21. Patient has history or diagnosis of glaucoma or ocular hypertension (baseline or a
known prior ocular exam indicating IOP >21 mm Hg)

22. Patient has closed angle (with or without the presence of peripheral anterior
synechiae on gonioscopy)

23. Patient has presence in either eye of: (i) posterior subcapsular cataract, (ii)
nuclear sclerosis of Grade +3 or higher; or (iii) cortical cataract of Grade +3 or
higher.