SpyGlass Pharma (SGP) investor relations material

Value proposition and market opportunity

• Focus on long-acting, sustained intraocular drug delivery for chronic eye conditions, targeting open angle glaucoma (OAG) and ocular hypertension (OHT).

• Lead candidate, BIM-IOL System, addresses a $13 billion U.S. market, aiming for multi-year IOP-lowering therapy.

• Designed for use by all cataract surgeons, expanding access to long-term OAG/OHT therapy.

• Platform enables delivery of multiple drugs for various eye conditions.

• Strong intellectual property with patents expiring between 2039 and 2043, and broad international coverage.

Clinical development and efficacy

• BIM-IOL System combines bimatoprost, cataract surgery, and IOL device for a streamlined intervention.

• Phase 3 pivotal trials underway; Phase 1/2 showed 98% of patients off topical therapy and 34% mean IOP reduction at 12 months with the 78 mcg dose.

• FIH trial showed 95% of patients off topical therapy and 37% mean IOP reduction at 36 months.

• Visual acuity maintained at ~20/20 at 12 months across all arms.

• Safety profile comparable to routine cataract surgery, with no serious ocular adverse events observed.

Regulatory and reimbursement pathway

• FDA-aligned 505(b)(2) NDA pathway for BIM-IOL System, leveraging historical bimatoprost data.

• Planned reimbursement via Medicare Part B, J-Code, and existing CPT codes.

• Clear approval pathway with multiple FDA meetings completed and active IND.