FDA Designates Orphan Drug status for TechFW client Nanoscope Technologies

Sight could come to those with damaged retinas thanks to Bedford-based Nanoscope Technologies, a SmartStart client of TechFW.

The company recently received Orphan Drug Designation from the U.S. Food & Drug Administration (FDA) for its use of optogenetics and its work on retinitis pigmentosa, also known as RP, which refers to a group of inherited diseases causing retinal degeneration.

“This is a very, very big deal and means their development will be fast-tracked through the FDA,” said Darlene Boudreaux, executive director of TechFW, in a news release. “It also has some considerable financial perks.” 

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NanoScope Technologies, with 10 employees, was founded by Samarendra Mohanty, the president and Chief Scientific Officer.

The company is located in Bedford because “we received approval for a pre-clinical research lab, have excellent access to TechFW, the convenience of DFW International Airport and a large number of former Alcon employees in the area,” Mohanty said.

Sulagna Bhattacharya, the CEO/COO of Nanoscope Technologies, said Orphan Drug Designation adds seven years of marketing exclusivity, patent term extension, eligibility for special FDA grants, application fee discounts and major tax breaks on clinical development worth approximately $10 million.

The virus (VMCO) and laser (NOD) techniques bypass damaged cells and inject a gene into working cells in the retina. The gene produces a protein that is light sensitive, helping the ganglion and bipolar cells regain sight. According to the release, the market potential in the U.S. alone for the orphan indication (RP) is approximately 200,000 people.

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Efficacy tests with rodents have been completed and no adverse effects have been noted thus far in large animal studies. Clinical trials will begin in 2018 and are expected to last 3-to-5 years.

Nanoscope Technologies’ science combines molecular biology, bio-medical optics, neuroscience and bio-medical engineering. Its research is funded by industry as well as NIH-SBIR’s and NEI’s Audacious Goal Initiative.

In addition to its work with restoration of vision, Nanoscope is testing its light-based technologies for non-invasive cancer detection and non-invasive chronic pain management.