Key Takeaways

  • The AMA approved a new add-on Category III CPT code (+X659T) for the attachment and insertion of SpyGlass Pharma’s investigational BIM-IOL System during routine cataract surgery
  • SpyGlass Pharma’s BIM-IOL System is designed to treat both cataracts and elevated IOP iin a single procedure by delivering bimatoprost continuously for up to 3 years
  • The company is currently conducting two phase 3 registrational trials, with enrollment expected to be completed in 2027 

SpyGlass Pharma announced that the American Medical Association’s (AMA) CPT Editorial Panel has approved a new add-on Category III CPT code for the attachment and insertion of an intraocular lens prosthesis-mounted drug-eluting implant. The application was submitted in support of SpyGlass Pharma’s investigational Bimatoprost Drug Pad-IOL System (BIM-IOL System), designed for use alongside standard cataract surgery procedures.

The newly approved code (+X659T), "Attachment and insertion of intraocular drug delivery implant," is intended for use in conjunction with established Category I cataract surgery CPT codes. Category III CPT codes are created to track emerging medical technologies and procedures, helping facilitate data collection and future reimbursement considerations.

“The approved Category III CPT code for attachment and insertion of the BIM-IOL System in conjunction with routine cataract surgery is an exciting moment in our path to product commercialization and reimbursement upon FDA approval,” said Patrick Mooney, Chief Executive Officer of SpyGlass Pharma. “In addition to breaking new ground clinically with the first-and-only product candidate addressing glaucoma and cataracts at the same time in a single intervention, we are excited to be breaking new ground on the commercial model with this additional supportive reimbursement pathway designed specifically for novel technologies like ours.”

The BIM-IOL System combines a standard IOL used in cataract surgery with proprietary non-bioerodible drug pads designed to continuously deliver bimatoprost over approximately 3 years. SpyGlass Pharma believes the system could address a longstanding challenge in glaucoma care: patient adherence to daily eye-drop regimens.

“The issuance of an add-on CPT code is an important milestone for all cataract surgeons interested in using the BIM-IOL System,” said Eric Donnenfeld, MD, Founding Partner of Ophthalmic Consultants of Long Island and former President of the American Society of Cataract and Refractive Surgery (ASCRS). “The potential for appropriate additional reimbursement associated with BIM-IOL System implantation is meaningful to our community and may further enable patient access to the BIM-IOL System.”

The company is currently evaluating the BIM-IOL System in two registrational phase 3 clinical trials involving patients diagnosed with OAG or OHT who also require cataract surgery. SpyGlass Pharma said enrollment in both studies remains on track for completion in 2027. In addition to the Phase 3 program, the company continues long-term follow-up from its earlier phase 1/2 clinical study assessing the safety and efficacy of the system.

SpyGlass Pharma stated it plans to continue working closely with the FDA as it advances toward completion of phase 3 trials, submission of a New Drug Application (NDA), and potential commercialization pending regulatory approval.