2Ctech announced the initiation of the first-known clinical program to demonstrate the effectiveness and safety of Quantum Dots (QDs) to achieve photovoltaic stimulation of the neural retina for preservation or enhancement of vision in patients with retinal degenerative diseases and, in particular, retinitis pigmentosa (RP).
In previous preclinical and first-in-human trials, a one-time injection of QDs was administered into the vitreous and trial outcomes provided strong evidence of safety and positive indications of meaningful vision enhancement. The next human studies are intended to meet the intent of FDA’s Early Feasibility Study (EFS) program requirements and will be conducted at several US sites.
“Retinitis Pigmentosa is a particularly challenging condition, with the prospect of almost certain vision loss and with no viable therapeutic options,” Chair, Department of Ophthalmology at University of Colorado, Naresh Mandava, MD, said in a company news release. “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.”
The preparation and implementation of these clinical trials has been enabled by a Series B funding of $8 Million. The initial planning and support for the product development, clinical strategy, and regulatory filings was supported by an initial Series B-1 investment of $4 million. Additional Series B-2 investments of $4 million were recently added. Funding is expected to support completion of the preclinical and clinical studies under well-defined protocols and to fully demonstrate safety and efficacy in a well-controlled and defined RP population. Prior funding of the company included approximately $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,” 2CTech President and CEO Jim Taylor said in the news release. “The opportunity to provide meaningful benefits for patients afflicted with RP is something that energizes everyone associated with this important program.”
Measurement of vision benefits in patients with inherited retinal diseases (IRDs) has been a significant challenge with respect to clinical trial designs and endpoint measures. As a result, recent guidance by the FDA has encouraged the use of “functional vision” as a primary endpoint. In 2CTech’s trials, mobility courses developed by Ora (Andover, MA) will be utilized as one of the key efficacy measures of therapeutic effects.
David A. Hollander, MD, MBA, Ora’s Chief Medical Officer, noted, “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.”