Summary

The axitinib intravitreal implant is investigational and has no established place in therapy. If approved, it would be the first tyrosine kinase inhibitor marketed for nAMD. Its pivotal evidence comes from adults aged 50 years or older with newly diagnosed nAMD: SOL-1 randomized 344 treatment-naive participants who, after two aflibercept 2 mg loading doses, reached a BCVA of about 20/20 or gained at least 10 letters with CSFT of 350 µm or less; SOL-R randomized 640 treatment-naive or recently diagnosed participants after a 6-month lead-in that excluded eyes with early persistent fluid or significant fluid fluctuation. No pivotal trial has enrolled previously treated participants with established disease; only the 21-participant U.S. phase 1 trial enrolled previously treated, anti-VEGF-responsive participants, using a different formulation. The sponsor anticipates a label allowing redosing every 6 to 12 months and positions the product as a maintenance treatment after anti-VEGF loading. Anticipated administration is an intravitreal injection with a 25-gauge needle by retina specialists in the office setting, the same care setting as current anti-VEGF injections, without concomitant corticosteroids. Sponsor-funded market research reports that about 80% of surveyed retina specialists would be likely to use a product with this profile; these data have not been independently published. Independent reviewers state that larger controlled trials are needed to define the role of sustained-release tyrosine kinase inhibitors in clinical practice.

Anticipated position as the first tyrosine kinase inhibitor for nAMD

“If approved, AXPAXLI would be the first tyrosine kinase inhibitor commercialized for the treatment of wet AMD.” (opens the source at this quote in a new tab)

Studied population: SOL-1 treatment-naive participants responding to aflibercept loading

“Under the trial protocol, subjects were eligible for enrollment in the SOL-1 trial if they were treatment-naïve for wet AMD in the study eye; had central subfield thickness, or CSFT, of less than or equal to 500” (opens the source at this quote in a new tab)
“Subjects reaching either a BCVA of greater than or equal to 84 ETDRS letters (approximately 20/20 Snellen equivalent vision) or experiencing an improvement of at least 10 ETDRS letters with a reduction in CSFT to no greater than 350 microns in the study eye after these injections were randomized in the trial on Day 1 (Baseline).” (opens the source at this quote in a new tab)

Studied population: sponsor description of SOL-1 enrollment

“Subjects were randomized in SOL-1 after showing a peak response to two aflibercept (2 mg) injections, reaching approximately 20/20 vision or experiencing an improvement of at least 10 Early Treatment of Diabetic Retinopathy Study (ETDRS) letters of best corrected visual acuity (BCVA), in addition to satisfying other criteria. This is a population that was specifically selected to lose vision.” (opens the source at this quote in a new tab)

Studied population: SOL-R treatment-naive or recently diagnosed participants

“The SOL-R trial is designed as a multi-center, double-masked, randomized (2:2:1), three-arm trial requiring subjects that were either treatment naïve or have been diagnosed with wet AMD in the study eye within about four months prior to screening.” (opens the source at this quote in a new tab)
“To qualify for screening in the SOL-R trial, a subject’s study eye must have had a BCVA of at least 34 ETDRS letters (approximately 20/200 Snellen equivalent vision).” (opens the source at this quote in a new tab)

Previously treated population: U.S. phase 1 trial only

“The trial enrolled a total of 21 subjects at six clinical sites, comprising two arms consisting of subjects previously treated with, and who were responsive to, standard of care anti-VEGF therapy: a 16-subject arm receiving AXPAXLI in combination with a single anti-VEGF injection at month one and a five-subject arm receiving on-label aflibercept at eight-week intervals.” (opens the source at this quote in a new tab)

Anticipated dosing interval: sponsor projection

“Potential AXPAXLI Label up to 12 Months” (opens the source at this quote in a new tab)
“NDA filing pending – does not reflect labeled dosing” (opens the source at this quote in a new tab)

“AXPAXLI is being developed to address this unmet need with the potential to extend dosing intervals to every 6 to 12 months and potentially provide superior and sustainable long-term visual outcomes.” (opens the source at this quote in a new tab)

Sponsor rationale for early initiation

“By starting AXPAXLI treatment early and sustaining disease control over multiple years, we have the opportunity to potentially improve long-term outcomes, reduce treatment burden, and significantly expand the number of patients who remain on therapy.” (opens the source at this quote in a new tab)

Care setting: office-based intravitreal injection by retina specialists

“It is the same intravitreal injection procedure we use every day, but with the potential for the therapy to last far longer, with possibly better long-term outcomes.” (opens the source at this quote in a new tab)

“Pre-filled intravitreal injection facilitates smooth practice integration” (opens the source at this quote in a new tab)

Prescriber base: retina specialists

“2.5 – 3K Retina Specialists in U.S.” (opens the source at this quote in a new tab)
“~600 HCPs account for 80% of claims volume” (opens the source at this quote in a new tab)

Anticipated uptake: sponsor-funded market research

“Following SOL-1's results, market research found that approximately 80% of retina specialists surveyed would likely use a product with AXPAXLI’s profile based on SOL-1 data alone, with more than 90% expected to adopt such a product within its first year, if approved.” (opens the source at this quote in a new tab)

“Ocular Therapeutix Market Research (n=53 Retina Specialists) Conducted February-May 2026, Retina Specialists surveyed at Medical Presentations of SOL-1 Data” (opens the source at this quote in a new tab)

Role of sustained-release tyrosine kinase inhibitors: independent review

“Continued evaluation through larger, controlled clinical trials is essential to validate these early findings and define the role of these agents in clinical practice.” (opens the source at this quote in a new tab)

Use in previously treated or anti-VEGF-refractory nAMD, fellow eyes, and switching from other agents

No evidence found.

Uptake of longer-interval agents in Medicare as an indicator of clinician preference for durability

“The increasing preference for aflibercept and faricimab suggests that clinicians are gravitating toward agents that balance efficacy with reduced injection frequency.” (opens the source at this quote in a new tab)
“The significant growth in faricimab use, despite its relatively high cost, suggests clinicians value extended treatment durability and reduced patient burden.” (opens the source at this quote in a new tab)
“The consistent escalation in total Medicare spending underscores the financial impact of intravitreal therapy on the US health care system, a trend that may be tempered by the introduction of biosimilars and alternative delivery systems.” (opens the source at this quote in a new tab)

Independent assessment of the evidence still needed for sustained-release tyrosine kinase inhibitors

“Intravitreal agents such as OTX-TKI and EYP-1901 have demonstrated encouraging durability and safety profiles in early-phase trials.” (opens the source at this quote in a new tab)
“Sustained delivery of VEGF receptor TKIs represents a promising frontier in the management of retinal and choroidal vascular diseases. The ability to reduce treatment burden while maintaining safety and efficacy addresses a significant unmet need in this space.” (opens the source at this quote in a new tab)
“Ongoing phase 2 and 3 trials will be critical in determining which of these novel delivery systems can meaningfully reduce treatment burden while preserving vision outcomes” (opens the source at this quote in a new tab)

AXPAXLI (axitinib intravitreal implant)

Place in treatment, anticipated use, and care setting