Shots:

• Patrick spoke about the 3-month data from the First-in-Human glaucoma treatment trial of Spyglass’ innovative  drug delivery platform that helps in lowering intraocular pressure in patients with glaucoma or ocular hypertension
• Patrick also talked about the study design and key findings from the First-in-Human glaucoma treatment trial
• The interview gives an understanding of Spyglass’ vision to develop novel treatments for chronic ophthalmic diseases

Smriti: Would you please highlight the characteristics of the SpyGlass drug delivery platform? How will this platform prove to be a better treatment option for patients with glaucoma?

Patrick Mooney: At SpyGlass, we are developing a groundbreaking, controlled-release, drug delivery platform capable of delivering years of ophthalmic medication in a way that will comfortably speak to all cataract surgeons.  Currently, millions of patients struggle to adhere to their daily eye drop regimen to control their chronic eye conditions.  In the near future, patients won’t have to struggle. The SpyGlass drug delivery platform will finally enable eye surgeons to place the medicine patients need directly inside the eye, which will provide multiple years of efficacy after a single implantation. The SpyGlass platform is uniquely designed to be implanted at the time patients are already undergoing cataract surgery. Solving multiple needs for ophthalmic patients at one time is highly desirable for doctors, patients, and surgical facilities.  

The lead SpyGlass program is designed to deliver multiple years of bimatoprost therapy to lower intraocular pressure (IOP) in patients with glaucoma or ocular hypertension.  

The most common method of reducing IOP today requires patients to take prescription eye drops daily. Sadly, adherence to daily therapy and improper administration of drops can impede optimal visual outcomes. For decades doctors have been looking for a way to guarantee adherence for their patients. The SpyGlass drug delivery platform is finally addressing this unmet need by delivering multiple years of uninterrupted therapy patients need to maintain their vision. 

The SpyGlass drug delivery platform consists of a single-piece, hydrophobic acrylic intraocular lens (IOL) and two drug-eluting pads that secure to the haptics of the IOL, prior to loading and implantation. With the drug pads secured at the haptic junction, the IOL and pads are loaded into a standard IOL injector and implanted through a sub 2.4mm cataract incision entirely into the capsular bag. We believe our approach will appeal to all cataract surgeons as implanting an IOL is a procedure completed millions of times each year in the US alone.   

Smriti: Shed some light on the study design of the First-in-Human trial evaluating the effectiveness of the SpyGlass drug delivery platform.

Patrick Mooney: For the First-in-Human trial, 23 patients with glaucoma or ocular hypertension undergoing cataract extraction were randomized to receive one of three doses of bimatoprost using the SpyGlass platform. After three months, the mean reduction in IOP across all groups was 45%, with 100% of patients achieving an IOP of 18 mmHg or lower without the need for additional therapy. No significant adverse events were reported, and visual outcomes were similar to those achieved with commercially available IOLs.

Smriti: What were the key findings obtained from the First-in-Human glaucoma treatment trial?

Patrick Mooney: Across all three doses, we saw a consistent and significant reduction in intraocular pressure.  Additionally, at 3 months post operatively, none of the patients needed additional IOP-lowering medicine to control their IOP. This too is compelling because in other clinical trials typically by 3 months, some patients need to be rescued with additional therapy. So far, we are not seeing this with the SpyGlass drug delivery platform, and this is quite encouraging.  We will continue to follow these patients over time and look forward to providing further updates early next year.  

Smriti: Give our viewers some insights into the advantages provided through the SpyGlass drug delivery platform over the conventional method of treating glaucoma.

Patrick Mooney: It is well known that eye drops are the most common method for lowering IOP to treat glaucoma, but poor adherence to daily therapy and improper administration can impede optimal visual outcomes. Patients struggle with the monthly costs of medications, side effects from their medications as well as having to remember to take their drops each day. The SpyGlass drug delivery platform solves all of these patient challenges at a convenient time when patients are already undergoing another ophthalmic procedure.  Additionally, the SpyGlass platform will appeal to all cataract surgeons as the skills needed to implant the SpyGlass platform skills cataract surgeons already have.  

Smriti: As you have mentioned the versatility of the SpyGlass platform across a range of eye diseases, tell us more about what other indications it can target.

Patrick Mooney: We’re very excited about our current pipeline of projects that leverage the unique drug-eluting capabilities of the SpyGlass platform. The platform is capable of delivering multiple drugs to address other eye conditions. For example, beyond glaucoma management, SpyGlass has active pipeline projects to deliver post-operative steroids and NSAIDs for the control of pain and inflammation. We have other pipeline projects that focus on delivering other pharmaceutical agents at different rates to address longer-term needs such as Chronic Uveitis and potentially macular degeneration. We believe the SpyGlass platform can address several chronic and acute eye conditions at a time when patients are already undergoing routine cataract surgery.  

Smriti: Tell us briefly about SpyGlass’ plans to proceed with its glaucoma-treating drug delivery platform in clinical trials and IND submission

Patrick Mooney: Meetings with both the U.S. Food and Drug Administration and Centers for Medicare and Medicaid Services have taken place, with clear registration and reimbursement pathways established. SpyGlass Pharma will file an Investigational New Drug application in the next 6 months and initiate the US Phase 1/2 trial in 2023.

Smriti: Lastly, what are the other indications within eye care/ Ophthalmology, SpyGlass is working on, and why only Ophthalmology?

Patrick Mooney: While our initial program focuses on glaucoma management at the time of cataract surgery, our platform can deliver a number of ophthalmic medications, offering versatility to treat a variety of eye conditions. Our initial efforts are aimed towards solving unmet needs within Ophthalmology because our team of scientists, engineers, and entrepreneurs have deep expertise within eye care. This means we understand the needs of ophthalmic patients and doctors and we have a passion for developing innovative solutions that improve the lives of patients.  

Source: Canva

About the Author:

Patrick Mooney is the CEO at SpyGlass Pharma. He is a seasoned leader in ophthalmology, having led several launches and commercialization efforts of ophthalmic pharmaceuticals and medical devices. Patrick has leadership experience in eye care spans the surgical, vision-care, and pharmaceutical spectrum, which includes product launches in Retina, Glaucoma, and Dry Eye as well as medical devices. Patrick is highly regarded across the industry for his deep insight into the eye care marketplace, his passion for developing and commercializing new products and therapies. He earned his bachelor’s degree in marketing from the University of Wisconsin-Whitewater.

Related Post: Tim Clackson, President & CEO of Theseus Pharmaceuticals, Shares Insights on its Pan-Variant Inhibitor Therapies to Treat Cancer