SpyGlass Pharma Inc., which is promising an intraocular lens that will reshape the treatment of glaucoma, emerged from its initial public offering last month with a big boost from Wall Street.
The Aliso Viejo-based biotech company went public on Nasdaq on Feb. 6 at $16 per share and closed at $26.40, a 65% increase. It also raised $172.5 million in gross proceeds, which will be used to complete its two ongoing Phase 3 trials and prepare for commercialization (Nasdaq: SGP).
“Going public now while we’re in Phase 3 in our pivotal trials makes a lot of sense,” Chief Executive Patrick Mooney told the Business Journal in one of the company’s first interviews post-IPO.
Trading on Wall Street showed that investors are not overly concerned about a pending lawsuit from larger rival Glaukos Corp., the maker of the world’s smallest medical device, which is inserted into the eye to treat glaucoma.
At press time, SpyGlass shares traded at $26.90 each for a $896 million market cap. Shares of Glaukos, also based in Aliso Viejo, traded at $98.96 and a $5.7 billion market cap (NYSE: GKOS).
Spyglass’ ‘Solid Track Record’
After more than six years of being a private company, Mooney said he believes SpyGlass has established a “solid track record” of executing its business plans and meeting milestones.
The company began enrolling and randomizing patients for Phase 3 trials in January, with enrollment expected to be complete by 2027. SpyGlass said it plans to submit a New Drug Application (NDA) to the FDA by 2028, positioning the company for a 2029 commercial launch, he said.
SpyGlass recently leased a new two-story, 33,000-square-foot office in Irvine for its new headquarters ahead of it scaling up for commercialization. The company currently employs more than 80 people and anticipates hiring more people in research and development and manufacturing roles.
“We love our space where we are today, but ultimately the team needs to grow,” Mooney said.
Announces 12-Month Phase 1/2 Results
SpyGlass says it’s developing the world’s first IOL-mounted drug-delivery platform capable of continuously delivering glaucoma medication called bimatoprost into the eye for up to three years.
Glaucoma is typically managed with daily eye drops to lower eye pressure, but many patients struggle to remember to take them consistently, according to Mooney. He said SpyGlass’ IOL “relieves patients of the burden of daily eye drops while improving visual outcomes.”
Last week, the company released 12-month results from its Phase 1/2 clinical trial evaluating the product for the treatment of intraocular eye pressure (IOP) in patients diagnosed with open-angle glaucoma or ocular hypertension.
Data showed that 97% of patients on SpyGlass’ IOL went off all topical IOP-lowering medication at 12 months. Additionally, 100% of patients achieved 20/32 or better best-corrected distance visual acuity, which is equivalent to 20/20 vision, according to Mooney.
“Our three-year first-in-human data previously reported great efficacy and outcomes, but one of the key challenges of that data was that it was single-site and not controlled,” Mooney said.
“So, I think the market has been waiting to see multi-center, randomized, controlled clinical data showing that our enduring efficacy holds up in a trial like this.”
The trial, which included 104 participants, compared SpyGlass’ platform to commercially available monofocal IOLs from Alcon, Bausch + Lomb, and Johnson & Johnson, with timolol eye drops in the control arm.
Two patient groups who received different dosages of SpyGlass’ IOL achieved a 34% and 42% reduction in intraocular pressure, compared to a 35% reduction in the control group.
Next-Generation Implant in Pipeline
In addition to funding Phase 3 trials and early commercialization planning, proceeds from the IPO will fund the first-in-human study for SpyGlass’ next-generation sustained-release implant, BIM-DRS (Drug Ring System).
The implant goes in the anterior segment, or the front third, of the eye, which includes the cornea, iris and lens through a small incision.
The BIM-DRS answers the question the company often hears: What happens after three years? The product is designed to serve as a retreatment option for patients who previously received a SpyGlass IOL.
“It expands the market for patients who are pseudophakic, meaning they’ve already had cataract surgery and they had glaucoma,” Mooney said. “Regardless of what intraocular lens they had received in their prior cataract surgery, we think the BIM-DRS program could be a meaningful solution.”
Animal trials are currently in progress with first-in-human trials planned for this year.
SpyGlass says its sustained drug delivery technology also can be applied to a wide range of chronic eye conditions, including age-related macular degeneration (AMD), chronic uveitis and postoperative eye care.
Glaukos Litigation Update
SpyGlass’ IPO registration revealed that the company is currently involved in litigation with Glaukos, which analysts expect will grow sales 20% this year to $613 million.
Glaukos on Sept. 17 sued one of its former clinical leaders, Long Doan, who is now vice president of clinical research at SpyGlass, for misappropriating trade secrets.
The suit, filed within the U.S. District Court for the Central District of California, claims that prior to resigning, Doan stole more than 11,000 confidential documents from Glaukos, including clinical, regulatory and commercial plans associated with the company’s iDose platform.
“I’ll simply say we think the claims lack merit and we intend to fully defend ourselves,” Mooney said.
The court granted Glaukos’ requests for a preliminary injunction last December, followed a month later by both parties submitting a Stipulation and Proposed Protective Order, which prevents sensitive information, such as trade secrets, from becoming part of the public record during litigation.
This month, Glaukos filed an amended complaint against Doan and SpyGlass.
“Glaukos believes the facts of the case are clear and the company is confident in its position,” Glaukos provided the following comment. “Glaukos has an obligation to its shareholders to vigorously protect its intellectual property.”
A trial has been set for this October, according to Glaukos.
