Name: AXPAXLI (axitinib intravitreal implant) in Neovascular age-related macular degeneration: Access and distribution
Published: 2026-09-17T18:54:38-04:00

Current access through clinical trials

“Subjects who have completed their two-year follow-up in either SOL-1 or SOL-R have an opportunity to enroll in the SOL-X study for an additional three years.” (opens the source at this quote in a new tab)

Manufacturing

“We have a single-site manufacturing facility for DEXTENZA, and we have a separate single-site manufacturing facility for product candidates that we use in our clinical trials and other research and development activities, including AXPAXLI.” (opens the source at this quote in a new tab)
“For example, we depend on a sole source supplier for the supply of our PEG.” (opens the source at this quote in a new tab)

Commercial readiness and payer engagement

“Ocular's payer team has also engaged 100% of Tier 1 Medicare Advantage and commercial payers, who have indicated that a label demonstrating superior durability could command premium pricing.” (opens the source at this quote in a new tab)

Commercial field and reimbursement team

“~50-person Field Team” (opens the source at this quote in a new tab)
“~15-person Reimbursement Team” (opens the source at this quote in a new tab)

Reimbursement risk stated by the sponsor

“For instance, if DEXTENZA ceases to be eligible for reimbursement separate from ophthalmic surgery in the ambulatory surgical center setting or if we are not able to achieve the pricing and reimbursement coverage we anticipate for AXPAXLI, if approved, our net product revenues would be impacted significantly” (opens the source at this quote in a new tab)

Patent protection

“AXPAXLI (axitinib intravitreal hydrogel) We own an issued patent in the United States that covers this product candidate, with a current expiration date in 2044 as well as corresponding pending U.S. and foreign counterpart applications, together with other issued patents in the United States and patents in certain foreign jurisdictions that cover this product candidate, with current expiration dates in 2041, as well as corresponding pending U.S. and foreign counterpart applications.” (opens the source at this quote in a new tab)

Expanded access program, HCPCS code, distribution channel, and REMS

No evidence found.

Coverage restrictions on anti-VEGF agents in United States commercial and Medicare Advantage plans

“A recent assessment of US commercial and MA health plans as of 2024 revealed substantial heterogeneity in coverage restrictions for these agents, including requirements for step therapy protocols, prescriber type, and patient subgroup criteria, with approximately 65% of commercial plans imposing restrictions beyond US Food and Drug Administration labeling.” (opens the source at this quote in a new tab)
“Notably, some plans excluded coverage for specific agents, such as brolucizumab, and varying reauthorization criteria further complicate access.” (opens the source at this quote in a new tab)
“These payer-driven differences likely reinforce the geographic disparities observed in Medicare utilization patterns in 2023.” (opens the source at this quote in a new tab)