Aliso Viejo-based SpyGlass Pharma Inc. yesterday announced the approval of a new add-on Category III CPT Code for its intraocular lens.
The code covers the attachment and insertion of the company’s IOL-mounted drug-delivery platform, capable of continuously delivering glaucoma medication called bimatoprost into the eye for up to three years.
“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,” Chief Executive Patrick Mooney said in a statement.
SpyGlass began enrolling and randomizing patients for Phase 3 trials in January, with enrollment expected to be complete by 2027. SpyGlass said it plans to submit a New Drug Application (NDA) to the FDA by 2028, positioning the company for a 2029 commercial launch, Mooney previously said.
Shares in SpyGlass were down 4.2% to $21.31 apiece and a $712 million market in the subsequent trading session (Nasdaq: SGP).
