Intraocular Drug Delivery: Patrick Mooney from SpyGlass Pharma in Conversation with PharmaShots

Shots:

Out of the 5M cataract procedures in the US, around one-fifth are conducted on patients with glaucoma or ocular hypertension. There’s an unmet need for drug delivery for patients who struggle with topical drops

Today, with PharmaShots, CEO of SpyGlass Pharma, Patrick Mooney, sharing insights from the data presented at the ASCRS Annual Meeting

Patrick talks about the Intraocular Lens Drug Delivery platform with bimatoprost, a medication that lowers intraocular pressure (IOP)

Saurabh: You have really knocked it out of the park with your innovative approach to treating Glaucoma. Could you please tell us more about your product – SpyGlass’s Intraocular lenses? 

Patrick: Thank you for recognizing the amazing innovation the team at SpyGlass is developing. We are excited about it too! At SpyGlass Pharma we are focused on bringing to market, the world’s first intraocular lens (IOL)-mounted, controlled release drug delivery platform capable of delivering multiple years of therapy to treat chronic eye diseases. We are starting with glaucoma. Additionally, our platform is capable of delivering several ophthalmic medicines including steroids, NSAIDS as well as small molecules to treat retinal diseases. Combining long-term drug delivery when patients are already undergoing routine cataract surgery creates efficiencies for patients, eye surgeons and for payors.

Saurabh: SpyGlass is an Ophthalmic Innovation. Could you please tell us how these lenses work and their mechanism of Bimatoprost delivery and that too for 3 long years?

Patrick: The SpyGlass Drug Delivery Platform consists of a single-piece, hydrophobic acrylic IOL and two drug-eluting pads containing bimatoprost, a medication that lowers intraocular pressure (IOP). The pads are secured at the haptic/optic junction and are assembled prior to loading and implantation. With the drug pads securely in place, the IOL & drug pads are implanted into the capsular bag, just as surgeons do routinely today during cataract surgery. The drug pads are non-bioerodible and do not change in size, shape, or volume over time. This is important to ensure the IOL continues to provide best in class visual performance for the lifetime of the patient. The IOL is made from the same monomers commercially available lenses use today and the optical performance seen in our clinical trials demonstrates our ability to deliver the same quality of vision we expect from common single piece monofocal IOLs used today. Our goal is to deliver best in class visual performance from the SpyGlass IOL and offer patients and their doctors an improved way to deliver years of critical medicine patients need to maintain their precious sight.

Saurabh: Could you highlight 1 Year of data from the human study on patients with Glaucoma implanted with Intraocular lenses? 

Patrick: Our first-in-human trial results are very promising. One year after implantation, patients experienced an average 44.6% reduction in IOP, with all patients showing a decrease of at least 20%. Additionally, all patients achieved an IOP of 18 mmHg or lower. This is significant as 18mmHg is considered an important IOP target to achieve for patients taking topical therapy today. Perhaps the most impressive finding to date is that 100% of patients remained off all topical IOP-lowering medications for 1 year. Prior to entering this study, these patients were taking between 1-3 medications to control their IOP. 1 year after implanting the SpyGlass platform with bimatoprost, 100% of patients were well controlled and did not need to go back on topical drops. From a safety standpoint, the SpyGlass platform was also well tolerated and there were no adverse events related to the product.

Saurabh: Since SpyGlass is currently enrolling patients for Phase 1/2 study in the US, what are the criteria for patient enrolment? 

Patrick: Yes, that is correct. SpyGlass is currently enrolling patients for a Phase I/II study in the US and we expect to complete enrollment this year. To be eligible, individuals must meet specific criteria which include having open angle glaucoma or ocular hypertension as well as a visually significant cataract. More detailed information can be found on the clinicaltrials.gov study page.

Saurabh: According to you, what are the anticipated challenges in scaling up SpyGlass lenses and how do you plan to overcome those challenges? 

Patrick: The team at SpyGlass is well versed in product development and scale up. Our co-founders previously developed other IOL technology which was acquired by Alcon in 2017. Additionally, our drug development team has experience developing ophthalmic drugs and devices and bringing them to market. As we finish our Phase I/II study this year, we are working diligently to scale up our manufacturing of both the IOL and drug pads. The processes and supply chain we are currently finalizing can carry us well into commercial launch. While this is indeed challenging work, we are confident we have the right team and partners on board to bring our vision to life. On the walls at SpyGlass, we have the words printed in large font “We Create for Patients.” We know patients are waiting and that motivates all of us daily to deliver for them.

Saurabh: What is the next step for SpyGlass in terms of commercial approvals and what are the plans for regulatory approvals? 

Patrick: Meetings with both the U.S. Food and Drug Administration (FDA) and Centers for Medicare and Medicaid Services have taken place, where we have established clear registration and reimbursement pathways. Our next step is to complete enrollment of the Phase I/II study to investigate the safety and efficacy of our platform in a larger patient pool. At the completion of this study, we will work closely with FDA on the design of our Phase III pivotal trials to advance the program to potential commercial approval.

Saurabh: What are the other products in the Spyglass pipeline and what indications? 

Patrick: We are excited about our pipeline. While the SpyGlass drug delivery platform with three years of bimatoprost therapy is a significant game changer for the market by itself, our technology is a platform capable of delivering multiple drugs to address other eye conditions. A key program in development today is our platform extension with bimatoprost, allowing for patients to be re-treated with bimatoprost providing another three years of IOP lowering. This platform extension can be removed and replaced every three years to care for the patients over their lifetime. We have other pipeline projects that focus on delivering drugs at different rates to address longer term needs, such as chronic uveitis and potentially age-related macular degeneration.

Image Source: Canva

About the Author:

Patrick Mooney

Patrick Mooney is a seasoned leader in ophthalmology, having led several launches and commercialization efforts of ophthalmic pharmaceuticals and medical devices. Most recently, he was Vice President and Head of the Ophthalmology Franchise at Novartis where he was responsible for the overall strategy and growth of U.S. Ophthalmic Pharmaceuticals.

Prior to Novartis, he led sales for Galderma’s Self Medication business unit and was with Alcon for 16 years, holding leadership positions of increasing responsibility in sales, marketing and operations in the United States and Asia. Patrick’s leadership experience in eye care spans the surgical, vision-care and pharmaceutical spectrum, and includes product launches in Retina, Glaucoma, Dry Eye as well as medical devices.

Patrick is highly regarded across the industry for his deep insight in the eye care marketplace, his passion for developing and commercializing new products and therapies that improve the lives of patients, and for his focus on developing people, and creating a strong team culture that yields successful business outcomes.