“They said it couldn’t be done without genetic testing.”

—Tech FW

.…The Fort Worth nonprofit marked Nanoscope Therapeutics’  just-watch-us moment on LinkedIn, as the local biotech made history with the first-ever FDA biologics application for a gene-agnostic therapy that could help blind patients see again.

Sometimes the most profound breakthroughs come from refusing to accept “impossible.”

“For the first time, patients who are considered to be on a path to permanent blindness may have a chance to regain sight,” Sulagna Bhattacharya, CEO and co-founder of Nanoscope, said in an announcement this week.

The Dallas-headquartered company recently began a rolling submission of its Biologics License Application to the FDA and has secured fast-track status, with full approval possible by early 2026. If cleared, MCO-010 would be delivered through a single, in-office injection—no surgery, repeat treatments, or genetic tests required.

“It’s the first time the FDA will be evaluating an application for a gene-agnostic therapy for inherited retinal disease,” added Glenn Sblendorio, chairman of the board for Nanoscope. 

Retinitis pigmentosa, a leading cause of inherited blindness, can be triggered by more than 100 genes and over a thousand known mutations. Existing treatments often require pinpointing the exact mutation, which means time-consuming and costly tests. Nanoscope’s therapy, known as MCO-010, works regardless of the underlying genetic cause—making it “gene-agnostic.”

In its pivotal Phase 2b trial, the therapy met its primary goals, according to the company. Patients saw vision improvements equivalent to reading at least three more lines on an eye chart, and these gains were sustained for three years without serious side effects in treated eyes.

“You didn’t just aim for the stars,” Tech FW wrote on LinkedIn about the Nanoscope team, “you built the telescope yourselves.”

For patients like the 25,000 Americans legally blind from RP, it might just help them see the light again.

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