Newly-launched VisiRose announced a $3 million seed financing round that will be used to further clinical development of its lead investigational program targeting therapeutics for severe ocular conditions.
First, a VisiRose refresh.
Jointly launched just last month by Provectus Pharmaceuticals, Inc. and the University of Miami, the clinical-stage biotechnology company is focused on one primary goal.
That purpose: Utilizing Provectus’s lead molecule (rose bengal sodium [RBS]) to commercialize rose bengal photodynamic antimicrobial therapy (RB-PDAT) for the treatment of ocular infections like infectious keratitis.
- Key to this: PV-305, an investigational candidate developed by Provectus and now VisiRose’s lead therapeutic.
Talk about these investigational therapies.
About RBS: As a bioactive synthetic molecule, this active pharmaceutical ingredient (API) is also part of the halogenated xanthenes, a class of small molecules developed by Provectus.
- The intended purpose: Using its antibacterial effect to kill drug-resistant bacterial strains in ophthalmic diseases as well as across other various disease indications (see its supporting clinical data).
About RB-PDAT: The noninvasive investigational therapeutic consists of a formulation featuring two components developed by the University of Miami’s School of Medicine (specifically: Bascom Palmer Eye Institute’s Ophthalmic Biophysics Center [OBC]).
- A light-based medical device
- Designed at the OBC, this is intended to treat bacteria, fungi, and parasitic-caused ocular infections like multidrug-resistant organisms
- RBS API
And how does RB-PDAT work?
With a multi-modal mechanism of action, this therapy involves a topical application and illumination of bioactive synthetic small molecule rose bengal (RB) in order to:
- Address multidrug-resistant pathogens
- Achieve timely complete resolution
- Avoid surgical intervention
For a better idea of how this works, click here to watch the treatment in action.
So how does PV-305 fit into this?
Under clinical development for infectious keratitis, Provectus’s investigational candidate is the subject of two randomized, double-masked clinical studies (NCT05110001 and NCT06271772) with one purpose:
- To determine the differences in 6-month visual acuity between medical antimicrobial treatments alone compared to antimicrobial treatment plus cross-linking with RB-PDT
Gotcha. Now circle back to that financing.
While no names were given identifying who or what fronted the funding for this round, the company did report that it will be used to support “continued progress” for VisiRose’s pipeline—including PV-305.
“The funding will enable us to advance [PV305] through critical regulatory steps, ultimately moving us closer to providing patients with innovative therapies for corneal diseases and other serious ocular conditions," stated Acting CEO Dominic Rodrigues.
Can you get into specifics on the company’s upcoming plans?
Yes! Provectus shared details on three upcoming key initiatives the financing will support:
- Completing an investigational new drug (IND) meeting with the FDA
- The focus: RB-PDAT
- Submitting an IND application
- The focus: For PV-305 to target corneal blindness via PDAT (and work toward FDA acceptance)
- Manufacturing an initial clinical supply
- The focus: For PV-305 to enable trial initiation, expanded access, and continued advancement toward regulatory approval
Sounds like a lot is in the works … what might we hear about first?
Great question … with no exact answer as yet. However, we do know that those two randomized clinical studies evaluating RB-PDT are slated to conclude this year (Q2 and Q4, according to Clinical Trials).
So stay tuned for updates!