Name: BIM-IOL System in Open-angle glaucoma or ocular hypertension: Access and distribution
Published: 2026-09-17T18:17:42-04:00

Product information and disease description Product description Product information

Access and distribution

6 evidence topics · 2 sources

Current access: investigational use in clinical trials only

“We are not permitted to commercialize, market, promote or sell any product candidate in the United States without obtaining marketing approval from the FDA.” (opens the source at this quote in a new tab)

Anticipated buy-and-bill model, Medicare Part B coverage, and J-code

“If we obtain marketing authorization for the BIM-IOL System, we anticipate that providers and facilities, including ASCs, will be able to immediately bill the product under a temporary J-code (J3490 or J3590). In parallel, we expect to apply for a Healthcare Common Procedure Coding System (HCPCS) Permanent J-code, similar to Durysta (J7351) and iDose (J7355), which are currently reimbursed at ASP plus 6%, consistent with other physician-administered drugs.” (opens the source at this quote in a new tab)
“Because the BIM-IOL System is implanted during cataract surgery, we expect that our product candidate will be covered through Medicare Part B.” (opens the source at this quote in a new tab)

Coding risk: miscellaneous J-codes before a product-specific code

“To the extent separate coverage or reimbursement is available for any product candidate, if approved, and a specific J-Code is not available, physicians would need to use a non-specific miscellaneous J-Code to bill third-party payors for these” (opens the source at this quote in a new tab)

Site of care

“We believe this presents an opportunity for providers and facilities, including ASCs, where approximately 90% of cataract surgeries in the United States are performed” (opens the source at this quote in a new tab)

Manufacturing and supply chain

“We currently use contract manufacturing organizations (CMOs) to manufacture and supply the components of our drug delivery system, including the drug pads, IOL and injector system.” (opens the source at this quote in a new tab)
“Clinical and commercial supply agreements for our proprietary IOL have been secured with our IOL supplier to meet our planned clinical and commercial requirements through our first year of commercialization.” (opens the source at this quote in a new tab)
“We have granted a right of first negotiation to an affiliate of this CMO to become an exclusive distributor of our potential commercial product in Asia, Europe, the Middle East and Africa.” (opens the source at this quote in a new tab)

Planned commercial field force

“We estimate that a limited number of cataract surgeons and ASCs perform the majority of cataract surgery procedures in the United States each year, with the top 5% of surgeons performing over 25% of the procedures” (opens the source at this quote in a new tab)
“We believe this concentrated market will enable us to build an efficient field-based sales force that can quickly unlock a significant portion of the market opportunity.” (opens the source at this quote in a new tab)

Expanded access program, specialty distribution, and REMS

No evidence found.