SpyGlass Pharma (SGP) Corporate presentation summary

Value proposition and market opportunity

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

• Lead product, BIM-IOL System, addresses a $13 billion U.S. market and is designed for use by all cataract surgeons.

• Over 80 million people globally are affected by OAG, with about 1 million U.S. patients projected to undergo cataract surgery annually.

• Only one-third of cataract surgeons currently perform MIGS, but BIM-IOL aims for universal adoption.

• Strong IP position with patents expiring between 2039 and 2043 and $251 million in cash as of March 2026.

Clinical development and efficacy

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

• Phase 3 pivotal trials are underway, with prior FIH results showing 95% of patients off topical therapy and 37% mean IOP reduction at 36 months.

• Phase 1/2 trials showed 98% of patients off topical therapy and 34% mean IOP reduction at 12 months with the intended commercial dose.

• Visual acuity outcomes were strong, with all arms achieving mean BCDVA of ~20/20 at 12 months.

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

Regulatory and reimbursement pathway

• Clear FDA-aligned approval pathway using 505(b)(2) NDA, leveraging historical bimatoprost data.

• Planned reimbursement via existing CPT codes and Medicare Part B, with drug expected to be covered and reimbursed at ASP + 6%.

• Multiple FDA meetings completed and active IND in place.