VisiRose: Blocking and Tackling
Seed Financing Press Release • Syndicated News Story • India Study Data • Regulatory Work
VisiRose Seed Financing
On Tuesday, January 14, 2025, VisiRose and Provectus both issued press releases to announce VisiRose’s first investment round:
VisiRose’s seed financing round is supporting several key ongoing initiatives:
Preparing for and completing a pre-investigational new drug (IND) submission meeting with the FDA for RB-PDAT for infectious keratitis,
Preparing and submitting an IND application for investigational eye drug PV-305, and working towards the IND’s acceptance by the FDA (as well as approaching Center for Devices and Radiological Health [CDRH] on the medical device side for feedback),
Manufacturing an initial clinical supply of PV-305 for VisiRose to initiate clinical trials and undertake expanded access post-IND acceptance, and
Applying for Small Business Innovative Research (SBIR) grant funding to support VisiRose’s clinical development of RB-PDAT for infectious keratitis and to undertake more novel research with Bascom Palmer Eye Institute (BPEI).
VisiRose Syndicated News Story
We worked with a vendor through our IR firm Alliance Advisors Investor Relations to develop a story about Rose Bengal Photodynamic Antimicrobial Therapy (RB-PDAT), BPEI, and VisiRose that could be syndicated in on-line news outlets across the country.
The goal of this initial story, Noninvasive Eye Infection Treatment Shows Promise, was to start laying the groundwork for building awareness. The story was first picked up by health and other editors, or the like, at ~2,600 online sites since late-last week. Here is an example of the placement of the story.
India Phase 3 RCT results
We believe the results from the India trial may be first presented at World Cornea Congress (WCC) IX, taking place March 20-22 in Washington, DC, and that the first author on the paper from last summer discussing the trial, Dr. Venkatash Prajna, is the one giving the presentation at the WCC. This is, of course, speculation on our part.
As background, the sponsor of this study, Rose Bengal Electromagnetic Activation With Green Light for Infection Reduction (REAGIR) (NCT05110001), is the University of California, San Francisco (UCSF). Since it is a U.S.-sponsored study, an IND application should have been filed for the study, but its very likely a research IND filed by the lead U.S. investigator, Jennifer Rose-Nussbaumer, MD, formerly of UCSF and now of Stanford University. These INDs are very different than corporate INDs, and typically meant to facilitate clinical research work.
Regulatory trench work
VisiRose’s regulatory consultants have been working to further develop its thesis to the FDA for VisiRose’s pre-IND submission meeting, and meeting with BPEI to aggregate, categorize, and assess its data before moving to data at international locations where BPEI RB-PDAT was studied in clinical settings (e.g., India, Brazil, Mexico, etc.). This work will also help define the prospective timeline for the pre-IND submission meeting and the IND submission, among other things.
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