Dallas-based Nanoscope Therapeutics has taken a major step toward offering new hope to people who are losing their vision from a rare eye disease. The company has started submitting its application to the U.S. Food and Drug Administration for approval of a new treatment called MCO-010, which could restore vision for patients with severe sight loss due to retinitis pigmentosa.
While potentially providing a significant market opportunity for the company, more importantly, MCO-010 would become the established standard of care for patients suffering from vision impairment due to RP.
RP is a genetic condition that causes gradual vision loss and often leads to legal blindness. It affects more than 100,000 people in the U.S. and currently has no cure. Most people with RP are legally blind by age 60.
“For the first time, patients who are considered to be on a path to permanent blindness may have a chance to regain sight,” said Sulagna Bhattacharya, Nanoscope’s CEO and co-founder, in a statement.
Nanoscope is a former client of TechFW.
If approved, Nanoscope’s therapy would be the first “gene-agnostic” therapy to restore vision in legally blind RP patients, meaning it could help a wide range of patients regardless of their specific genetic mutation. That is a significant breakthrough considering that the disease is linked to more than 100 genes.
MCO-010 is a one-time injection into the eye that can be done in a regular doctor’s office. It uses a special protein to make certain cells in the retina sensitive to light, even after the normal light-sensing cells have died. Unlike other treatments, it doesn’t require surgery, repeat doses, or genetic testing.
In clinical trials, patients who received MCO-010 showed strong improvements in vision. Some were able to read three more lines on an eye chart — a major gain — and those results lasted up to three years with no serious side effects.
“We’ve seen this investigational therapy surpass our expectations in the lab and in patients in clinical trials,” said Dr. Samarendra Mohanty, the company’s president and chief scientific officer. “We believe we’re now one step closer to potentially bringing this pioneering therapy to all RP patients.”
The FDA has given MCO-010 “fast-track” status, meaning the review process will be quicker. Nanoscope expects to finish its application in early 2026.
“Based on the preclinical science and evidence in clinical trials, MCO-010 represents a potential, important paradigm shift for patients and retina specialists, providing hope for meaningful improvement in the quality of life for the neediest retina patients of all,” said Dr. Allen C. Ho, an adviser to Nanoscope.