SpyGlass Pharma (SGP) investor relations material

Key product and market insights

• Introduced a drug-eluting intraocular lens system addressing both cataracts and glaucoma in a single procedure, targeting a $13 billion market with 1 million annual U.S. procedures and global expansion potential.

• The system delivers up to three years of bimatoprost therapy, with a secondary implant offering up to seven additional years, potentially providing a decade of treatment from two surgeries.

• Product fits seamlessly into existing cataract surgery workflows, enabling all cataract surgeons to address glaucoma without new skills or equipment.

• Competitive advantage includes accessibility to three times more surgeons compared to current MIGS devices, with clear regulatory and reimbursement pathways.

• Strong intellectual property protection and $151 million in cash support ongoing development and commercialization plans.

Clinical development and efficacy

• Phase I/II trials showed 95% of patients off topical therapy and a 37% mean IOP reduction, with strong safety and efficacy replicated in multicenter phase II trials.

• Phase II data demonstrated 34% mean IOP reduction and 98% of subjects off all topical IOP-lowering medications at one year.

• Visual outcomes matched or exceeded leading monofocal lenses, with no serious ocular adverse events observed.

• Phase III trials underway with two parallel protocols, each enrolling 400 patients, focusing on IOP reduction and visual acuity as co-primary endpoints.

• Protocol adjustments in phase III include lowering maximum IOP and reducing allowed topical drops to minimize variability.

Commercialization and reimbursement strategy

• Product leverages established cataract surgery codes and Medicare Part B reimbursement, with a new Category 3 CPT code for additional surgeon revenue.

• Facilities benefit from drug revenue tied to existing procedures, and reimbursement models are being refined ahead of launch to ensure confidence.

• Commercial launch strategy focuses on high-volume cataract centers and building robust field sales and reimbursement teams.

• Team has extensive experience launching ophthalmology products under Med B buy-and-bill models.