SpyGlass Pharma Inc. has raised a $75 million Series D round that brings the company closer to commercializing its intraocular lens (IOL).
Proceeds from the round, announced at the beginning of June, will help fund two large Phase 3 trials, which are set to begin later this year.
“This not only allows us to complete our Phase 3 trials, but extends us from a cash runway well beyond completion of our Phase 3 readout,” Chief Executive Patrick Mooney told the Business Journal.
“This is ours to operationalize and be successful with.”
The round was led by Sands Capital with participation from new and existing investors, including Gilde Healthcare, Samsara BioCapital and Vertex Ventures HC.
SpyGlass previously raised a $90 million Series C round in 2023, making its total funding to date approximately $200 million.
The Aliso Viejo-based biotechnology company says it’s developing the world’s first IOL-mounted drug delivery platform, capable of continuously eluting up to three years of glaucoma medication to the eyes.
Its technology originated from the University of Colorado School of Medicine and was spun off by Dr. Malik Kahook and Glen Sussman, who co-founded the company in 2019.
Enrolling 800 Patients in Two Phase 3 Trials
SpyGlass completed enrollment for its Phase 1/2 trial last year.
The study will evaluate the safety and efficacy of the company’s IOL compared to a control group that will receive commercially available IOL followed by topical IOP-lowering drops.
Mooney said that they will track participants over three years as per protocol.
The Phase 1/2 trial is supported by positive first-in-human feasibility study that showed an at least 20% reduction in intraocular pressure (IOP) in all participants at the 18 month mark.
SpyGlass plans to present two-year data from the study in October, according to Mooney.
He said that the company has already had its End of Phase 2 meeting with the Food and Drug Administration, allowing it to move onto Phase 3 trials.
“The FDA is supportive of SpyGlass moving forward into Phase 3,” Mooney said. “Our clinical trial protocol is almost identical to our Phase 2 protocol.”
SpyGlass expects to begin enrolling around 800 patients for its two Phase 3 trials later this year and be fully enrolled by 2027. Mooney said that the FDA requires two Phase 3 trials for the regulatory pathway it’s seeking for its IOL.
Following this timeline, Mooney believes that SpyGlass’ drug delivery platform will be a “successful FDA-approved commercial product” by 2029.
New Chief R&D Officer
Helping lead the company through these trials will be Dr. Chetan Pujara, who was appointed the company’s new chief research and development officer in March.
Pujara brings over 20 years of experience in pharmaceutical and drug-device product development.
Prior to SpyGlass, Pujara was chief development officer at San Francisco-based biotechnology company Osanni Bio, where Bobak “Bobby” Azamian, chief executive of Irvine-based Tarsus Pharmaceuticals Inc., is on the board of directors.
Pujara previously held leadership roles at Abbott Laboratories, Allergan and AbbVie.
“The SpyGlass drug delivery platform technology is poised to substantially improve care for glaucoma patients, with great potential to expand into additional ophthalmic areas,” Pujara said in a statement.
As for commercialization plans, Mooney said that the company’s primary target market is the U.S. but that they’re “interested in the global markets,” particularly Western Europe, Japan and Canada.
The company is also open to launching the product in partnership with another company, according to Mooney.
“We intend to commercialize this ourselves, but if one of the larger companies wishes to partner or acquire at some point, we’re open to that,” he said.