By Tom Ballard, Director of Innovation and Entrepreneurial Initiatives, Pershing Yoakley & Associates, P.C.
The President of Bristol-based Anew Optics, Inc. brings a diverse background to an early stage company focused on revolutionizing the intraocular lens market for individuals undergoing cataract surgery.
Anna Hayes is a former investment banker, Chief Financial Officer of a small biotechnology company, and sheep farmer.
“I regard myself as an industrial generalist,” she told us in a recent teknovation.biz interview. At the same time, Hayes noted that one of her brothers is an ophthalmologist, so the sector on which Anew Optics focuses is not foreign to her.
Today, Hayes and her partner are on the cusp of launching European trials early next year for their Zephyr lens. Their journey started nine years ago with what she described as an “investigative process.” Anew Optics was incorporated in 2008 with manufacturing launched in 2010.
Like many businesses, Hayes said hers was significantly slowed during the economic recession.
“The transformation (of Anew Optics) in the last five years has been amazing,” she added.
In the early years, Hayes says she and her partner spent a good deal of time attending conferences and listening to ophthalmologists.
“We learned what they did not like about cataract lenses and what they were seeking,” she said.
Anew Optics has based its work on understanding the natural 360-degree physics of the eye and how it wants to heal itself after cataract surgery.
“Currently available lenses don’t manage fibrosis and, if you don’t manage fibrosis, we don’t believe you have a long-term solution,” Hayes says. “Our lens goes into the eye, keeps the capsule open, and allows the aqueous humor to circulate in the capsule.”
She explains that this approach helps to eliminate fibrotic reactions by keeping the capsule from closing on itself.
Over its life, Anew Optics has developed several iterations of its lenses, producing an improved lens each time. Hayes described an early version as “clunky.” Getting the sizing right was another challenge.
“We did tests in rabbits and used the data to tell us what changes we needed to make,” she explained.
Now, Anew Optics is ready to go to the next level – human trials. There are several reasons to start in Europe rather than the U.S. The most obvious are cost and time.
“Securing U.S. Food and Drug Administration (FDA) approval is an arduous, expensive and very drawn-out process,” Hayes says. Between 390 and 450 patients must be monitored for three years in the U.S. compared to 125 patients for a year in Europe.
The costs and time are challenging for any start-up, particularly one like Anew Optics with minimal funding.
“We have done really well on a shoestring over five years . . . $5 million rather than $100 million and maybe 10 years,” Hayes notes.
That said, Anew Optics clearly intends to eventually offer its product to U.S. consumers.
“We will use the European sales revenue to fund the required trials here,” Hayes explains. “We have a very profound commitment to making this happen.”