2Ctech, Inc., a privately owned development stage company concerned with the application of nanoparticle technologies for the treatment of retinal diseases, announced the launch of the first-ever clinical program to show the effectiveness and safety of Quantum Dots (QDs) to realize photovoltaic stimulation of the neural retina for preserving or improving vision in patients with retinal degenerative diseases and, specifically, Retinitis Pigmentosa (RP).
In the earlier pre-clinical and first-in-human trials, a one-time injection of QDs administered into the vitreous and trial results offered strong proof of safety and positive indications of significant vision improvement. The next human studies are aimed at realizing the goal of FDA’s Early Feasibility Study (EFS) program requirements and will be carried out at many US sites.
Retinitis Pigmentosa is a particularly challenging condition, with the prospect of almost certain vision loss and with no viable therapeutic options. As a result of the innovative work performed by Dr. Jeffrey Olson and our team at the Sue Anschutz-Rodgers Eye Center, we will now have the opportunity for this exciting technology to be validated and strengthened by this important clinical study.
Naresh Mandava, MD, Chair-Department of Ophthalmology, University of Colorado.
The preparation and execution of these clinical trials have been facilitated by a Series B funding of $8 million. The preliminary planning and support for the product development, clinical strategy, and regulatory filings were supported by an initial Series B-1 investment of $4 million. Further Series B-2 investments of $4 million were recently added. Funding is likely to support completion of the pre-clinical and clinical studies under well-defined protocols and to completely exhibit safety and efficacy in a well-controlled and defined RP population. Previous funding of the Company included around $2.5 million in combined grants and early Series A investments.
We are more than gratified to have reached this point in the development of this unique and high-potential therapeutic approach for what are otherwise debilitating retinal diseases and conditions. The opportunity to provide meaningful benefits for patients afflicted with RP is something that energizes everyone associated with this important program.
Jim Taylor, President and CEO, 2CTech.
Measurement of vision advantages in patients with inherited retinal diseases (IRDs) has been a major problem with regard to clinical trial designs and endpoint measures. Consequently, new guidance by the FDA has supported the use of “functional vision” as a primary endpoint. In 2CTech’s trials, mobility courses created by Ora, Inc. (Andover, MA) will be employed as one of the main efficacy measures of therapeutic effects.
We are proud to collaborate with our partners to provide an endpoint for demonstrating clinically meaningful changes in visual function through immersion of patients in a 360-degree visual challenge environment and we are excited to work with 2CTech on their novel application of QD devices for the treatment of RP.
David A. Hollander, MD, MBA, Chief Medical Officer, Ora, Inc.