Summary: development and regulatory status

As of September 2026, the axitinib intravitreal implant (AXPAXLI, OTX-TKI) is investigational and is not approved in any country. It is in phase 3 development for neovascular age-related macular degeneration (nAMD) in three trials: SOL-1 (superiority versus a single injection of aflibercept 2 mg; conducted under an FDA Special Protocol Assessment), SOL-R (non-inferiority versus aflibercept 2 mg every 8 weeks; 640 participants randomized), and the open-label extension SOL-X. The sponsor completed a pre-NDA meeting in September 2026 and plans to submit a New Drug Application under section 505(b)(2) in the fourth quarter of 2026, based on SOL-1 Week 52 efficacy and safety data, interim Week 52 safety data from a subset of SOL-R participants, and confirmatory evidence. The sponsor plans to submit SOL-1 Year 2 safety data at the 120-day safety update to support repeat dosing, and describes a potential launch in 2027 if approved. No FDA expedited program designation, European Medicines Agency submission, or other ex-U.S. regulatory filing was identified.

Investigational status and product name

“AXPAXLI is a trade name which we use to refer to our OTX-TKI product candidate.” (opens the source at this quote in a new tab)
“Food and Drug Administration, or FDA, has not approved AXPAXLI as a product name.” (opens the source at this quote in a new tab)

Current development phase in nAMD

“AXPAXLI is currently being evaluated in a Phase 3 registrational program for wet age-related macular degeneration, or wet AMD, which we refer to as the SOL program.” (opens the source at this quote in a new tab)

Special Protocol Assessment agreement and modifications for SOL-1

“We received an agreement letter regarding the overall trial design from the FDA under the SPA agreement on October 30, 2023.” (opens the source at this quote in a new tab)
“We received an agreement letter regarding the first SPA agreement modification from the FDA on January 22, 2024.” (opens the source at this quote in a new tab)
“We received an agreement letter regarding the second SPA agreement modification from the FDA on February 24, 2025.” (opens the source at this quote in a new tab)

FDA feedback on the SOL-R trial and a one superiority plus one non-inferiority trial package

“At the time, the FDA also noted that the use of one superiority trial and one non-inferiority trial is generally acceptable as the basis of an eventual NDA in wet AMD.” (opens the source at this quote in a new tab)

Planned NDA content after the May 2026 Type C meeting

“The NDA is expected to include the Week 52 efficacy and safety data from the SOL-1 trial, together with interim Week 52 safety data for a subset of subjects in the SOL-R trial and confirmatory evidence.” (opens the source at this quote in a new tab)
“To provide safety information for a minimum of 300 subjects in the aggregate with at least one year of treatment with AXPAXLI in accordance with FDA guidance and to supplement the 170 subjects who received AXPAXLI in the SOL-1 trial, we plan to conduct an interim safety analysis of the SOL-R trial during the fourth quarter of 2026 assessing all subjects who have completed the Week 52 time point at the time of analysis.” (opens the source at this quote in a new tab)
“SOL-R efficacy data is not part of our planned NDA submission.” (opens the source at this quote in a new tab)

Repeat-dosing data planned for the 120-day safety update

“At the standard 120-day safety update following the submission of our NDA, we plan to submit Year 2 safety data from the SOL-1 trial to the FDA to support the potential inclusion of repeat dosing on a label for AXPAXLI, if approved.” (opens the source at this quote in a new tab)

Regulatory submission: NDA planned for the fourth quarter of 2026

“Based on the Pre-NDA Meeting, the Company’s expectations for the AXPAXLI NDA package remain consistent with prior FDA communications, including the May 2026 Type C Meeting. Ocular remains on track to submit the NDA in the fourth quarter of 2026.” (opens the source at this quote in a new tab)
“The September 2026 Pre-NDA Meeting further confirmed alignment with the FDA on the content and format of the planned NDA submission under the 505(b)(2) pathway, which has the potential to shorten the FDA review timeline by up to 60 days as compared to the traditional 505(b)(1) pathway for a new molecular entity.” (opens the source at this quote in a new tab)

Basis for the 505(b)(2) pathway

“Because axitinib is FDA-approved for non-ophthalmic indications, we plan to submit an NDA under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act, or FDCA, which has the potential to shorten the review timeline for AXPAXLI by up to two months compared to the traditional review pathway for new molecular entities” (opens the source at this quote in a new tab)

SOL-R protocol amendment and revised topline timing

“Following these changes, topline SOL-R results are now expected in the first quarter of 2028. The trial's primary endpoint, non-inferiority of AXPAXLI to aflibercept (2 mg) at Week 56, remains unchanged.” (opens the source at this quote in a new tab)

Launch: Anticipated in 2027

“Commercial readiness accelerates ahead of potential 2027 launch as AXPAXLI is well positioned to potentially be the first TKI approved for wet AMD” (opens the source at this quote in a new tab)

FDA expedited program designations, EMA submissions, and other ex-U.S. regulatory filings

No evidence found.

AXPAXLI (axitinib intravitreal implant)

Phase of product development