Is Discovisc (sodium hyaluronate) FDA approved?

FDA Approval Status of Discovisc (Sodium Hyaluronate)

Discovisc (sodium hyaluronate 1.6%-chondroitin sulfate 4.0%) is FDA approved as an ophthalmic viscosurgical device (OVD) for use during cataract surgery, but is not FDA approved for nasal or rhinologic applications.

Ophthalmic Applications

• Discovisc is classified as a "viscous dispersive" ophthalmic viscosurgical device (OVD) that combines properties of both cohesive and dispersive OVDs 1
• It was developed as an alternative to the "soft-shell technique" which requires using two separate OVDs (Viscoat and Provisc) during cataract surgery 2
• Clinical trials have demonstrated that Discovisc has comparable safety and efficacy to the combined use of Viscoat and Provisc in phacoemulsification procedures 2

Sodium Hyaluronate in Medical Applications

• Sodium hyaluronate is FDA approved for various ophthalmic applications as evidenced by FDA-approved labeling 3
• Sodium hyaluronate is a physiological glycosaminoglycan found naturally in the extracellular matrix, synovial fluid, cartilage, epidermis, and vitreous body 4
• It has been deemed safe for cosmetic use at concentrations up to 2% according to safety assessments 5

Rhinologic Applications of Sodium Hyaluronate

• While sodium hyaluronate has been studied for use in chronic rhinosinusitis (CRS) treatment, these applications are not FDA approved 6
• Multiple European studies have evaluated sodium hyaluronate as an addition to saline irrigation or nebulization for CRS patients, particularly post-operatively 6
• Several randomized controlled trials have shown benefits of sodium hyaluronate in CRS treatment including:
  • Reduced scar formation, crusting, and secretions post-operatively 6
  • Improved quality of life measures (SF-36, SNOT-22 scores) 6
  • Reduced nasal obstruction and discharge symptoms 6

Important Distinctions

• In endoscopic procedures, sodium hyaluronate has been studied as a submucosal injection solution for creating longer-lasting tissue elevation during endoscopic mucosal resection 6
• For colorectal polyp removal, sodium hyaluronate has shown superiority over normal saline for submucosal injection, but this application is not FDA approved in the US 6
• The FDA has approved sodium hyaluronate for specific medical applications (primarily ophthalmic), but not for the rhinologic applications described in European studies 3

Clinical Implications

• Despite showing promise in European studies for CRS treatment, clinicians should be aware that using sodium hyaluronate products like Discovisc for nasal applications would constitute off-label use in the US 6
• When considering sodium hyaluronate for CRS, note that nebulization with small volumes showed more positive outcomes than irrigation with larger volumes in European studies 6
• The European Position Paper on Rhinosinusitis and Nasal Polyps (EPOS) 2020 acknowledges these studies but does not make strong recommendations for routine use 6