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Patrick Mooney, CEO of SpyGlass Pharma, sat down with Onyx for a feature -length interview.
Let's talk about what you and your team have created. How does the SpyGlass platform work and how does it compare to existing treatments?
The current standards of treatment for glaucoma involve topical medications—drops that lower intraocular pressure, or IOP for short. These medications either slow down the production of aqueous humor or help the aqueous humor to drain faster. Essentially, glaucoma is a plumbing problem: the drain is clogged, but the faucet is still on. This translates into higher IOP which can injure the optic nerve, leading to vision loss.
For decades, eye doctors have relied on patients to be adherent to taking their drops daily, but there are many reasons why they might not be adherent—cost, forgetfulness, dexterity issues. It's hard for patients to get a tiny drop out of the bottle and into their eye. The medicines we use today work very well, but only when taken properly.
We've taken that very medicine that does work well—a fundamental first-line agent in the category of prostaglandin analogues—and chosen Bimatoprost as the active pharmaceutical ingredient. This drug has been used commercially for decades as a trusted first-line therapy, and we've figured out a long-term drug delivery solution implanted at the time of routine cataract surgery.
Cataract surgery is one of the most common outpatient procedures in the United States. All of us, if we live long enough, will likely need cataract surgery. There are about 5 million procedures in the US each year, and 20% of those are performed on patients with glaucoma. Unfortunately, most of the time, it's just the cataract that's being addressed without treating the glaucoma.
What is so special about SpyGlass is that we've figured out a way to combine long-term drug delivery with a drug that we know works. We have a device that’s implanted within the course of a very common medical procedure—cataract surgery. Implanted while the patient is already in the operating room. So, known drug, known procedure, known device.
We're targeting three years of drug delivery, which is unheard of. Topical drops typically need to be taken every single day for the rest of the patient's life. Our system takes the very medicine they need and puts it inside the eye during routine cataract surgery, so those patients have these three years of medicine on board to manage their disease.
We're not asking the surgeons to learn new skills. The surgeon is inserting this device into the eye during the same procedure they know by heart. Now they can give the patient not only the benefit of the restoration of sight from the cataract removal but also implant the very medicine they need to manage their glaucoma. It's really exciting, and eye doctors often tell me, SpyGlass is one of the most exciting developments in ophthalmology.
How did you determine the three-year duration for drug delivery?
Well, we believe the longer, the better. Existing drug delivery products on the market last months rather than years. When we asked physicians what they needed, their answer was six to twelve months would be amazing.
We didn't think that was good enough. We knew from our research that we could get longer. When we told them we could get three years they wanted to know when they could have it!
Where are you with the FDA?
We're just finishing up our Phase II trial now. We'll be sitting down with the FDA early next year, and we plan to start our Phase III pivotal—or registration—trials in 2025 as well. I'm happy to say the clinical data so far are very strong.
Are there patients for whom this treatment wouldn't work so well?
I'd say most patients respond very well. It's rare that a patient wouldn't respond to this medication.
We're targeting patients with mild to moderate glaucoma. If they're going to be on topical therapy, SpyGlass could be a great option for them. Patients may be on topical therapy for years, and when they need cataract surgery, SpyGlass would be a good option for patients to reduce their treatment burden and better manage their disease because the medication they need is already in their eye, where it needs to be, 24/7.
Have you found that patients are anxious about the concept of having something implanted in their eye?
No, and I think the reason is they're already going to the operating room for a cataract procedure because their vision has been deteriorating, and they're receiving an implant already. With SpyGlass technology we're benefiting from the fact patients are already scheduled for a cataract procedure and we’re implanting an intraocular lens (IOL) into the exact same part of the eye surgeons are implanting IOLs without medicine on board. With SpyGlass, patients will benefit from having their vision restored and have multiple years of IOP-lowering medicine in their eye, reducing the daily treatment burden on patients and caregivers.
Are you also looking toward other drugs and conditions as well?
We have a secondary implant in pipeline development that will allow patients to be treated and extend them beyond three years. When the initial term of three years is up, and patients need to be retreated, all options are on the table. All surgical interventions are available to them, patients can go back on drops if they wish, and they'll have an option from SpyGlass as well.
Our aim is to provide a secondary implant and extend the platform for an additional 3 years. This secondary implant is designed to be repeated every three years or as needed for the lifetime of the patient. We aim to take care of each patient’s glaucoma for their lifetime, as well as provide options for other chronic eye diseases in the future.
In our pipeline, we are exploring long-term drug delivery of other small molecules for additional indications such as treating retinal diseases—AMD (age-related macular degeneration).
Is there a difference in patient outcomes between administering eye drops multiple times a day versus continuous release of the medication?
We're achieving around 40% reduction in IOP at 18 months and beyond so far in our clinical studies. In contrast, when used as a topical eye drop, this same drug lowers IOP by 20 to 30%. We're releasing a tiny amount of bimatoprost per day inside the eye compared to the large drop that is used each day for topical therapy. Our entire payload is less than a single drop of the topical medication.
Looking to the future, where would you like to take SpyGlass next?
We've got a great team and investors on board. We feel we've de-risked this asset as much as humanly possible. I know there's a ton of work yet to do, but so far, our clinical data are very compelling.
We intend to move into two Phase III pivotal trials next year and begin enrolling patients. We are also planning to take the company public. We have lots of options on the table. We're talking to interested third parties as well.
But make no mistake, our goal is to bring this to patients. There are a million procedures occurring every year just in the United States with cataract-plus-glaucoma patients. If you follow some of the other tech in the market today and use current list prices for those same technologies, this is over a $13 billion total addressable market—just in the United States.
The aspiration for long-term drug delivery has been there for decades. Surgeons have wanted to take control and help patients manage their disease more effectively. Until the last couple of years, there haven't been many significant improvements.
In ophthalmology—especially with chronic diseases like glaucoma and retinal diseases —there's a push to go from taking daily drops or receiving monthly injections to options that provide medicine for several months to years. We’re proud of our 3-year target as SpyGlass is clearly leading the industry with aspirations to deliver multiple years of needed medicine with our product.
I think you're going to see significant interest continue to move into longer-term drug delivery of known medicines. No one debates that the medicines we have today are very effective. The challenge is, can we deliver them in a way that improves care, as well as making disease management easier. You're going to see that movement continue to grow, and that’s why SpyGlass is so exciting.
Do you have a personal motivation for your work?
Growing up in the Midwest, I was surrounded by good, hardworking people. My father and grandfather were both in sales and business. I'd watch my dad and grandfather discuss how they interacted with people and enjoyed helping others. It was something I identified with as a kid.
Then, when I was seven or eight, we took a trip to Disney World, and while the park was nice, it was really the airplane ride that captivated me.
That's all I could talk about. I wanted to be a pilot. I began my professional career in vision care and always recognized the connection to my childhood passion of flying. Excellent vision is essential for being a pilot. This increases my joy for what we are doing since we are creating a product that will help preserve vision for so many people who desperately need it.
And did that kid ever learn to fly?
Yes I did! I got my pilot's license and I've been a general aviation pilot for the last 22 years.
