BIM-IOL System

No price, cost-effectiveness analysis, budget impact model, or health technology assessment has been published for the BIM-IOL System, and no published cost-effectiveness or budget impact analysis of the approved intracameral implants (Durysta or iDose TR) was identified. The sponsor plans to submit a 505(b)(2) NDA in 2028.

The sponsor estimates a US total addressable market of approximately $13 billion, based on the estimated 1 million patients with glaucoma or ocular hypertension undergoing cataract surgery each year, the proportion of glaucoma that is open-angle, and the wholesale acquisition cost of iDose TR, which Glaukos set at $13,950 per implant in December 2023. The sponsor expects the system to be covered under Medicare Part B, billed first under a temporary J-code (J3490 or J3590) and then under a permanent product-specific J-code, and reimbursed at ASP plus 6%, as for Durysta (J7351) and iDose TR (J7355), and states that approximately 90% of US cataract surgeries are performed in ambulatory surgery centers. Medicare Part B payment limits for July to September 2026 were $213.756 per 1 mcg for J7351 and $196.746 per 1 mcg for J7355. The sources disagree on the procedure code: the May 2026 company announcement lists the approved add-on Category III CPT code as +X659T, whereas the August 2026 results announcement reports the code released on July 1, 2026 as +1090T, for use with cataract surgery codes such as 66984 and 66991.

The nearest published economic evaluations concern MIGS devices implanted during cataract surgery. A US Medicare model estimated incremental cost-utility ratios for the Hydrus microstent with cataract surgery, compared with cataract surgery alone, of USD 38,346.43 in mild and USD 42,895.38 in moderate glaucoma over 2 years; a 35-year US societal model found that Hydrus or iStent inject with cataract surgery dominated or was cost-effective compared with cataract surgery alone; and a 2-year budget impact model of the OMNI surgical system in a hypothetical US plan with 1 million Medicare-covered lives estimated a total cost decrease of $35,362. For the topical comparator class, Medicare spending on prostaglandin analogs was $1.09 billion in 2017, of which 86% was for branded products, and median Medicare Part D glaucoma medication spending was $403.81 per beneficiary from 2019 to 2023. Budget impact for the BIM-IOL System cannot be estimated from public data as of September 2026.