Provectus Biopharmaceuticals, Inc. and the University of Miami (via the School of Medicine’s Bascom Palmer Eye Institute) have agreed to an exclusive worldwide license for Miami’s photodynamic antimicrobial therapy (PDAT) intellectual property, designed to treat bacterial, fungal, and parasitic (acanthamoeba) eye infections.
Give me the rundown on these players.
Provectus is a clinical-stage biotechnology company developing immunotherapy medicines based on a class of synthetic small-molecule immuno-catalysts: halogenated xanthenes (HXs).
The disease targets: oncology, dermatology, hematology, virology, microbiology, and ophthalmologyIts lead molecule: rose bengal sodium (RB)
Now this deal.
Per the agreement, Provectus will form a majority-owned start-up company that Miami will have a minority equity shareholder stake in.
The goal: to develop and commercialize Miami’s PDAT medical device in combination with a formulation of RB.
Note: One other stipulation includes Provectus contributing a license to this new company as well as an exclusive RB supply arrangement.
Talk about RB.
Background first: Rose bengal is a dye used in ophthalmic clinics for staining corneal or conjunctival epithelial defects and degeneration.
For Provectus, RB is a proprietary pharmaceutical-grade active ingredient with antibacterial properties that have been used for diagnosing ophthalmic diseases and liver function; it’s also been studied for the potential treatment of solid tumor cancers.
To support these properties, its mechanism of action (MOA) has also undergone studies and been published in various peer-reviewed publications over the last few years.
The findings thus far: Pharmaceutical-grade RB is very effective in killing most Gram-positive bacteria.
And this PDAT?
Led by Bascom Palmer’s Ophthalmic Biophysics Center (OBC) Director Jean-Marie Parel, Ing.ETS-G, PhD, FAIMBE, FARVO, researchers developed the RB-PDAT as a form of crosslinking since it has been investigated as an adjunct treatment for infectious keratitis.
Dr. Parel and OBC researchers have reportedly spent years advancing the RB-PDAT technology against different types of treatment-naïve and -resistant keratitis, and have “established the merits of its innovation through extensive in vitro testing, pilot in vivo safety and clinical studies.”
Dive deeper on this technology.
- Its function: PDAT with rose bengal operates as a photosensitizer combined with green light optical irradiation.
- Its dual purpose: to prevent infection progression and strengthen the cornea’s collagen
- The intent: for RB-PDAT to become a standard therapy for preventing “progression to perforations and obviate the need for therapeutic keratoplasties,” as well as—potentially—an affordable and effective treatment for mitigating corneal blindness.
- Click here for clinical details and findings on its efficacy for infectious keratitis.
Any ongoing research into it?
Yes, actually. It’s currently being studied in two international randomized, double-masked phase 3 clinical trials for two forms of keratitis:
- Acanthamoeba and fungal (or atypical bacteria) (NCT05110001)
- Rose Bengal Electromagnetic Activation With Green Light for Infection Reduction (REAGIR) study
- n = 330 (estimated)
- Purpose: determine differences in 6-month visual acuity (VA) between medical antimicrobial treatments (topical chlorhexidine gluconate 0.02%, moxifloxacin 0.5%, or natamycin 5%) alone vs antimicrobial treatments plus cross-linking with RB-PDT.
- Study locations: Aravind Eye Hospitals in India or the Federal University of São Paulo, Brazil
- Estimate completion: July 2025
- Rose Bengal Electromagnetic Activation With Green Light for Infection Reduction (REAGIR) study
- Bacterial (NCT06271772)
- REAGIR II study
- n = 60 (estimated)
- Purpose: determine differences in 6-month visual acuity (VA) between medical antimicrobial treatments alone vs a combination of antimicrobial and steroid treatments (difluprednate 0.05% and moxifloxacin 0.05% ophthalmics) plus cross-linking with RB-PDT.
- Study locations: Aravind Eye Hospitals in India or the Federal University of São Paulo, Brazil
- Estimated completion: July 2025
- REAGIR II study
Note: For the detail-oriented folks in the audience, RB-PDT is a nomenclature found in ClinicalTrials studies that is equivalent to RB-PDAT!
And the overall significance of this deal?
By working to commercialize this RB-PDAT technology, Provectus’s Ed Pershing, Board of Directors chair, stated that this new Provectus spinout company seeks to “reduce or eliminate the risk of blindness and impaired vision from eye infections for millions of people around the world.”