SpyGlass Pharma (SGP) H.C. Wainwright 28th Annual Global Investment Conference summary

Market opportunity and clinical need

• Addressable market for combined cataract and glaucoma treatment is $13 billion, targeting 1 million U.S. patients annually and 5.4 million globally.

• 20% of cataract surgery patients have glaucoma or ocular hypertension, representing a significant unmet need.

• Existing alternatives like iDose are limited in accessibility and require changes in surgical technique.

• Poor adherence to topical glaucoma drops leads to suboptimal outcomes for many patients.

• The new product aims to simplify care by integrating drug delivery into standard cataract surgery.

Product innovation and differentiation

• The intraocular lens (IOL) with drug pads delivers bimatoprost for up to three years, requiring no changes to standard surgical procedures.

• Accessible to all cataract surgeons, unlike minimally invasive glaucoma surgeries performed by only a third of surgeons.

• Drug pads are nearly invisible post-surgery and do not interfere with future glaucoma treatments.

• The product uses FDA-approved materials and leverages existing reimbursement codes.

• A follow-up Drug Ring System allows for retreatment years after initial surgery.

Clinical data and regulatory pathway

• First-in-human study showed 95% of patients off additional therapy at three years, with 37% mean IOP reduction.

• Phase I/II trial with over 100 patients showed 98% off topical therapy and 34% mean IOP reduction at 12 months for the 78 mcg dose.

• Visual acuity outcomes matched commercial IOLs, with 100% achieving 20/30 or better.

• Phase III trials underway with 800 patients, focusing on IOP reduction and visual performance.

• NDA submission targeted for 2028, with potential product launch in 2029.