Assessment of the Anti-inflammatory Effects of NORFLO® ORO in Acute Relapses of HLA-B27-associated Autoimmune Uveitis: A Multicenter, Randomized, Placebo-controlled, Double-blind Clinical Study

ABSTRACT

Background

An effective therapy to reduce the number and severity of HLA-B27-related acute anterior uveitis (AAU) recurrences represents a clinical need. Curcumin is a promising therapeutic option in various inflammatory eye diseases. To enhance its absorption and eye tissue selectivity, a phospholipidic-curcumin complex (PHBC) has been formulated (Iphytoone®, Eye Pharma S.p.A.).

Aims

This study investigates if PHBC is effective and safe to decrease the number and intensity of HLA-B27-related AAU relapses.

Methods

HLA-B27-related AAU patients were randomly divided to receive PHBC or placebo for 12 months (NCT03584724).

Results

Compared with the previous year, the number of relapses decreased in both groups. The proportion of responders was significantly higher in the PBHC group. The severity of attacks was comparable. The study drug was well tolerated.

Conclusions

A beneficial effect of PHBC treatment is suggested because the proportion of responders was significantly higher in this group of patients.

KEYWORDS:

• Phospholipidic high bioavailability curcumin (PHBC)
• HLA-B27-associated acute anterior uveitis (AAU)
• Laser Flare Meter (LFM)
• AAU relapses

Acknowledgments

Editorial assistance was provided by Simonetta Papa, PhD, and Aashni Shah (Polistudium SRL, Milan, Italy). This assistance was supported by Eye Pharma S.p.A.

Authors’ contributions

Study design: All; data collection and interpretation: All; manuscript writing: Pia Allegri, Ilknur Tugal-Tutkun; manuscript editing and approval to submit: All.

Consent to participate

All the participants signed an informed consent form.

Consent for publication

Not required as this manuscript doesn’t include details, images or videos related to the participants.

Disclosure statement

No potential conflict of interest was reported by the author(s).

Data availability statement

Data may be made available upon reasonable request.

Ethics approval

The study was approved by the institutional review board of each center and was conducted in compliance with Good Clinical Practices, including the archiving of essential documents.

Additional information

Funding

This study is sponsored by Eye Pharma S.p.A.