Registered study summary

“Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) in Subjects with Neovascular Age- Related Macular Degeneration” (opens the source at this quote in a new tab)

Company-stated objective: non-inferiority of dosing every 24 weeks

“We are also conducting the SOL-R trial, a repeat-dosing Phase 3 clinical trial to evaluate the non-inferiority of AXPAXLI 450 μg dosed every 24 weeks for the treatment of wet AMD compared to aflibercept 2 mg dosed on-label every eight weeks.” (opens the source at this quote in a new tab)

Original role as the second registrational trial

“In a Type C written response, the FDA agreed that the SOL-R repeat dosing wet AMD study is appropriate as an adequate and well-controlled study in support of a potential New Drug Application (NDA) and product label. The FDA also noted that the use of one superiority study and one non-inferiority study is generally acceptable as the basis of an eventual NDA in wet AMD.” (opens the source at this quote in a new tab)

Revised role after the May 2026 FDA Type C meeting

“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. SOL-R efficacy data is not part of our planned NDA submission.” (opens the source at this quote in a new tab)

“Because SOL-R efficacy is no longer part of the planned NDA submission or review, Ocular intends to leverage the trial to best serve its long-term strategic objectives for AXPAXLI.” (opens the source at this quote in a new tab)

Summary: registry sites compared with company-reported countries

The ClinicalTrials.gov record (last updated 2025-06-17) lists 97 locations: 84 in the United States, 10 in Argentina, 2 in Australia, and 1 in Puerto Rico. It lists no sites in India, whereas company filings and releases from 2025 and 2026 describe sites in the United States, Argentina, India, and Australia, and a November 2025 release describes approximately 100 sites. The registry study start date (2024-11-27) is later than the company-reported initiation (June 2024) and first enrollment (July 2024); the registry start date coincides with the month in which direct enrollment opened (November 2024), according to a June 2025 presentation.

Registry dates

Milestone	Registry record
Study start (actual)	“2024-11-27”
Primary completion (estimated)	“2027-01-08”
Study completion (estimated)	“2027-01-08”
Last update posted	“2025-06-17”

Registry location count

“This study has 97 locations” (opens the source at this quote in a new tab)

Company-reported initiation and first enrollment

“In June 2024, we initiated the SOL-R trial, a repeat-dosing registrational Phase 3 clinical trial for the treatment of wet AMD.” (opens the source at this quote in a new tab)
“The first subject was enrolled in the SOL-R trial in July 2024.” (opens the source at this quote in a new tab)

Enrollment periods

“Initially enrolled SOL-1 randomization failures” (opens the source at this quote in a new tab)
“Opened direct enrollment in Nov 2024” (opens the source at this quote in a new tab)
“Closed enrollment end of May 2025 with loading and randomization ongoing” (opens the source at this quote in a new tab)

Company-reported countries and number of sites

“The SOL-R trial includes sites located in the U.S., Argentina, India, and Australia.” (opens the source at this quote in a new tab)

“Subjects for SOL-R are enrolled across approximately 100 sites in the U.S., Argentina, India, and Australia.” (opens the source at this quote in a new tab)

Earlier description of site regions: January 2025

“311 subjects enrolled across various stages of loading and randomization in the U.S. and South America as of January 10, 2024.” (opens the source at this quote in a new tab)

Registered design

“A Phase 3, Multicenter, Double-Masked, Randomized, Parallel Group Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) in Subjects With Neovascular Age- Related Macular Degeneration” (opens the source at this quote in a new tab)

Three-arm randomized design with a 2:2:1 ratio

“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)

Six-month screening and loading lead-in before randomization

“Over the six month screening and lead-in period prior to Baseline (Day 1) randomization, enrolled subjects were given three screening doses of any anti-VEGF therapy, excluding brolucizumab-dbll, and two monthly loading doses of aflibercept 2 mg prior to Day 1, and monitored to exclude subjects demonstrating early persistent fluid or significant retinal fluid fluctuations.” (opens the source at this quote in a new tab)

Aflibercept 8 mg arm for masking instead of sham injections

“A third arm evaluating 8 mg aflibercept dosed Q6M is incorporated in the SOL-R study to ensure adequate masking, following the FDA’s recommendation that sham injections do not provide complete masking and therefore may elicit potential bias.” (opens the source at this quote in a new tab)

Rescue criteria: loss of more than 5 letters combined with CSFT increase

“The clinical trial protocol requires that, during the trial, subjects in any arm meeting pre-specified rescue criteria will receive a supplemental dose of aflibercept 2 mg. The pre-specified rescue criteria include a loss of more than 5 ETDRS letters in BCVA from best recorded prior visit (baseline or later) due to wet AMD, combined with an increase of 75 microns or more in CSFT from prior lowest measurement (baseline or later) due to wet AMD.” (opens the source at this quote in a new tab)

“The pre-specified rescue criteria include a >5-letter loss in visual acuity plus a ≥75 μm increase in CSFT.” (opens the source at this quote in a new tab)

Rescue criteria: May 2025 description with a 10-letter threshold

“The pre-specified rescue criteria include loss of ≥ 10 Early Treatment Diabetic Retinopathy Study (ETDRS) letters of BCVA from baseline or a combination of worsening anatomical measures and BCVA loss.” (opens the source at this quote in a new tab)

Redosing schedule: 2024 description with a single redose at Week 24

“In the first arm, subjects are randomized to receive a single dose of AXPAXLI at Day 1 and are re-dosed at Week 24. In the second arm, subjects receive aflibercept (2 mg) on-label every 8 weeks. In a third arm, subjects receive a single dose of aflibercept (8 mg) at Day 1 and are re-dosed at Week 24, aligned to the AXPAXLI treatment arm for adequate masking.” (opens the source at this quote in a new tab)

Redosing schedule: current description with redosing at Weeks 24, 48, and 72

“Subjects in the first arm of the SOL-R trial received a single dose of AXPAXLI 450 μg at Day 1 and are re-dosed with AXPAXLI 450 μg at Weeks 24, 48, and 72.” (opens the source at this quote in a new tab)

Protocol amendment in 2026: masking extended to Week 96

“We have no plans to enroll additional subjects in SOL-R and are amending the trial protocol to extend sponsor masking through Week 96 to evaluate the new secondary endpoints described above.” (opens the source at this quote in a new tab)

Interim safety analysis and alpha penalty

“All data other than safety data for the interim analysis population will remain masked following the interim analysis, and SOL-R will incur a 0.0001 alpha penalty in connection with its primary statistical analysis as a result of conducting the interim analysis.” (opens the source at this quote in a new tab)

FDA written responses on registrational adequacy

“In a written Type C response received in August 2024, and a subsequent written response received in December 2024, the FDA agreed that the SOL-R repeat dosing wet AMD trial, with a primary endpoint at Week 56, should be appropriate as an adequate and well-controlled trial in support of a potential NDA and product label for AXPAXLI for the treatment of wet AMD.” (opens the source at this quote in a new tab)

Registered inclusion criteria

“Treatment naïve juxtafoveal and/or SFNV secondary to Neovascular Age- Related Macular Degeneration (nAMD) with leakage involving the fovea in the study eye prior to Screening, or have a diagnosis of Neovascular Age- Related Macular Degeneration (nAMD) in study eye within 3 months prior to screening and received up to 2 monthly injections of 2 mg aflibercept with last injection approximately 4 weeks prior to Screening” (opens the source at this quote in a new tab)
“Have provided written consent” (opens the source at this quote in a new tab)

Registered exclusion criteria

“Monocular subject or Best Corrected Visual Acuity (BCVA) score of <20 ETDRS letters or 20/400 in fellow eye at Screening” (opens the source at this quote in a new tab)
“Have evidence of a scar, fibrosis, or atrophy of >50% of the total lesion in the study eye.” (opens the source at this quote in a new tab)

Company-described diagnosis window and visual acuity threshold

“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)

Diagnosis window: 2024 description of three months

“The trial is intended to randomize approximately 825 subjects who are treatment naïve or diagnosed with wet AMD in the study eye within three months prior to enrollment.” (opens the source at this quote in a new tab)

Retinal thickness stability criteria before randomization

“Subjects maintaining a CSFT of no greater than 350 microns at Weeks -12 and -8, and not experiencing a CSFT increase of greater than 35 microns at Week -8 from their lowest CSFT at any prior visit, received these loading doses at Weeks -8 and -4 prior to randomization on Day 1.” (opens the source at this quote in a new tab)

Enrollment of SOL-1 loading and randomization failures

“Patients enrolled in SOL-R are initially expected to include patients that constitute loading or randomization failures from the SOL-1 study.” (opens the source at this quote in a new tab)

Registered interventions

Arm	Registered intervention description
OTX-TKI Re-dose	“Intravitreal Injection of OTX-TKI”
Aflibercept 2mg on label	“Intravitreal Injection of 2mg of aflibercept”
Aflibercept 8mg high dose	“Intravitreal Injection of 8mg of aflibercept”

Randomized treatment regimens

“Subjects in the first arm of the SOL-R trial received a single dose of AXPAXLI 450 μg at Day 1 and are re-dosed with AXPAXLI 450 μg at Weeks 24, 48, and 72. Subjects in the second arm received aflibercept 2 mg on Day 1 and per label every eight weeks thereafter. Subjects in the third arm received a single dose of aflibercept 8 mg at Day 1 and are re-dosed at Weeks 24, 48, and 72. Subjects will be followed for safety until Week 96. Trial subjects and designated trial personnel will remain masked through the end of Week 96.” (opens the source at this quote in a new tab)

Formulation used in phase 3 trials

“We are currently conducting the SOL-1, SOL-R and HELIOS-3 trials, and we plan to conduct the SOL-X trial and, if needed, the HELIOS-2 trial with a 450 µg axitinib dose of AXPAXLI, or AXPAXLI 450 µg, which is a different formulation than we used in either of the two Phase 1 trials of AXPAXLI that we have completed for the treatment of wet AMD.” (opens the source at this quote in a new tab)

Supplemental aflibercept after randomization

“Subjects in any arm that meet pre-specified rescue criteria will receive a supplemental dose of aflibercept (2 mg).” (opens the source at this quote in a new tab)

Primary endpoint: company definition at Week 56

“The primary endpoint of the SOL-R trial is to demonstrate non-inferiority in mean BCVA change from baseline between the AXPAXLI and on-label aflibercept 2 mg arms at Week 56. The third arm (aflibercept 8 mg) of the SOL-R trial is not part of the non-inferiority analysis at Week 56. Based on FDA guidance, the non-inferiority margin for the lower bound for the trial has been established at -4.5 letters of mean BCVA.” (opens the source at this quote in a new tab)

Primary endpoint: registry definition at Week 48

Field	Registry record
Primary outcome measure	“Best Corrected Visual Acuity (BCVA)”
Description	“Mean change in Best Corrected Visual Acuity (BCVA) from baseline at Week 48”
Time frame	“Week 48”

Primary endpoint: earlier descriptions at one year and Week 48

“The primary endpoint is non-inferiority in mean best corrected visual acuity (BCVA) change from baseline between the AXPAXLI and on-label aflibercept (2 mg) arms at one year.” (opens the source at this quote in a new tab)

“Demonstrate that AXPAXLI is non-inferior to fixed-dose aflibercept 2 mg with respect to mean change in BCVA at Week 48 from baseline in wAMD patients” (opens the source at this quote in a new tab)

Non-inferiority margin based on FDA guidance

“Compare to labeled dosing of Aflibercept 2 mg or Ranibizumab 0.5 mg (-4.5 letter margin)1” (opens the source at this quote in a new tab)
“Primary analysis: AXPAXLI dosed Q24W versus Aflibercept 2mg Q8W” (opens the source at this quote in a new tab)

Company rationale for the Week 56 timepoint

“A singular Week 56 primary endpoint in SOL-R is potentially favorable as subjects will have received their most recent aflibercept or AXPAXLI injection eight weeks prior, at Week 48.” (opens the source at this quote in a new tab)

Company rationale for screening out early persistent fluid

“Screening to exclude subjects with early persistent fluid may be critical for trial success” (opens the source at this quote in a new tab)

Interpretation of rescue injections in non-inferiority trials

“FDA generally does not consider a single rescue as a treatment failure1” (opens the source at this quote in a new tab)
“Rescues in close proximity (<3 months) to the primary endpoint will fall under greater regulatory scrutiny1” (opens the source at this quote in a new tab)

Key secondary endpoint added in 2026: superiority to aflibercept 8 mg at Week 96

“We are amending the trial protocol to add a new key secondary endpoint to evaluate the superiority of AXPAXLI to aflibercept (8 mg) at Week 96.” (opens the source at this quote in a new tab)
“This new key secondary endpoint will be evaluated at Week 96 to align as closely as possible with the aflibercept (8 mg) Year 2 approved dosing interval, which was recently expanded to up to every five months after one year of treatment.” (opens the source at this quote in a new tab)

Secondary endpoints added in 2026: fibrosis and atrophy at Week 96

“To further assess differentiation from aflibercept (2 mg), dosed every eight weeks in the SOL-R trial, we also intend to evaluate the prevention of fibrosis and atrophy through secondary endpoints at Week 96 with the goal of expanding a potential AXPAXLI label in the future.” (opens the source at this quote in a new tab)

Registered secondary outcome measures

No evidence found.

Registry estimated enrollment

Field	Registry record
Enrollment (estimated)	“825”

Planned randomization: approximately 825 subjects (2024)

“Company plans to initiate SOL-R AXPAXLI repeat dosing study (Phase 3, wet AMD) to evaluate repeat dosing of AXPAXLI (450µg) at six months (Q6M) compared to aflibercept (2mg) dosed every eight weeks (Q8W) and a comparator arm dosed Q6M in 825 wet AMD patients.” (opens the source at this quote in a new tab)

Planned randomization: at least 555 subjects (2025)

“Based on current and projected screening, loading, and randomization failure rates observed in SOL-R to date, Ocular believes it has enrolled enough subjects to ensure the Company’s target randomization of at least 555 subjects in SOL-R.” (opens the source at this quote in a new tab)

“Ocular will continue to allow randomization of previously enrolled subjects currently in the loading phase of the trial to maintain its commitment to both patients and investigators, with topline data remaining on track for the first half of 2027.” (opens the source at this quote in a new tab)

Statistical power

“The trial is 90% powered to detect a non-inferiority margin of -4.5 letters of mean BCVA when compared to aflibercept (2 mg) dosed every 8 weeks.” (opens the source at this quote in a new tab)

Randomized participants: 631 (February and June 2026)

“We have completed randomization of the SOL-R trial with 631 subjects randomized.” (opens the source at this quote in a new tab)

“In December 2025, the trial completed the randomization of 631 subjects.” (opens the source at this quote in a new tab)

Randomized participants: 640 (August 2026)

“We have now completed randomization of the SOL-R trial with a total of 640 subjects randomized.” (opens the source at this quote in a new tab)

“In December 2025, the trial completed the randomization of 640 subjects.” (opens the source at this quote in a new tab)

Planned interim safety analysis population

“SOL-R Interim 52-week safety (n >130 patients)” (opens the source at this quote in a new tab)
“SOL-1 52-week safety (n=170 at 52 weeks) plus” (opens the source at this quote in a new tab)

Primary non-inferiority comparison excludes the aflibercept 8 mg arm

“The third arm (aflibercept 8 mg) of the SOL-R trial is not part of the non-inferiority analysis at Week 56.” (opens the source at this quote in a new tab)

Interim safety analysis set

“Ocular plans to conduct an interim safety analysis of patients completing one year in SOL-R during the fourth quarter of 2026 to reach an aggregate of greater than 300 patients with at least one year of treatment across SOL-1 and SOL-R. Because of the interim analysis, SOL-R will incur a 0.0001 alpha penalty during its statistical analysis.” (opens the source at this quote in a new tab)

Efficacy analysis population and handling of rescue injections

No evidence found.

Retention

“Subject retention in the SOL-R trial remains high.” (opens the source at this quote in a new tab)

Discontinuations and reasons

No evidence found.

Topline timing: first half of 2027 (November 2025)

“Ocular will continue to allow randomization of previously enrolled subjects currently in the loading phase of the trial to maintain its commitment to both patients and investigators, with topline data remaining on track for the first half of 2027.” (opens the source at this quote in a new tab)

Topline timing: first quarter of 2027 (February 2026)

“We expect topline data from the SOL-R trial to be available in the first quarter of 2027, an acceleration from our previous guidance of the first half of 2027.” (opens the source at this quote in a new tab)

Topline timing: first quarter of 2028 (June and August 2026)

“Topline data for the SOL-R trial are expected to be available in the first quarter of 2028.” (opens the source at this quote in a new tab)

“This includes maintaining masking of SOL-R to subjects, investigators, and the Company until Week 96 to evaluate new secondary endpoints, with topline data now expected in first quarter of 2028.” (opens the source at this quote in a new tab)

Primary and secondary efficacy results

No evidence found.

Exploratory SOL-1 analysis applying SOL-R rescue criteria: Week 24

“In a prespecified exploratory analysis applying the SOL-R protocol rescue criteria to the SOL-1 results, AXPAXLI demonstrated a 77.1% rescue-free rate at Week 24. Week 24 was selected as the timepoint for this analysis to align with the re-dosing interval being used in the SOL-R trial.” (opens the source at this quote in a new tab)

Post hoc SOL-1 analysis applying SOL-R rescue criteria: Week 52 and treatment burden

“The proportion of SOL-1 patients who would have remained rescue-free under the SOL-R rescue criteria of >5 ETDRS letter loss and ≥75 µm CSFT increase from baseline was 66.5% at Week 52.” (opens the source at this quote in a new tab)
“The total estimated mean injection burden with AXPAXLI represents a 72% reduction counting from the first screening visit at Week -8 excluding loading doses and a 56% reduction when loading doses are included, as compared to a projected on-label dosing regimen of aflibercept (2 mg) with no rescues.” (opens the source at this quote in a new tab)

Planned interim safety analysis in the fourth quarter of 2026

“Ocular remains on track to conduct the interim SOL-R safety analysis and submit the AXPAXLI NDA in the fourth quarter of 2026.” (opens the source at this quote in a new tab)

Adverse events

No evidence found.

Summary

SOL-R has reported no efficacy or safety results as of 2026-09-17; topline data are expected in the first quarter of 2028, and only interim Week 52 safety data are planned for the NDA submission in the fourth quarter of 2026. Company sources report the randomized sample as 631 participants (February and June 2026) and 640 participants (August 2026), both described as completed in December 2025, while the registry still lists an estimated 825 participants. The primary endpoint timepoint is Week 56 in company sources and Week 48 in the registry, which was last updated 2025-06-17, and a 2024 congress presentation. Company descriptions of the rescue criteria changed between May 2025 (loss of at least 10 letters from baseline, or anatomic worsening combined with vision loss) and November 2025 onward (loss of more than 5 letters combined with a CSFT increase of at least 75 µm). The six-month lead-in excluded participants with early persistent fluid or CSFT fluctuation, so the randomized population is enriched for anti-VEGF-responsive disease and may not represent all patients with newly diagnosed neovascular age-related macular degeneration. Supplemental aflibercept is permitted in all arms, so outcomes in the axitinib implant arm will reflect combined exposure in rescued participants. The June 2026 amendment added a key secondary superiority comparison with aflibercept 8 mg and fibrosis and atrophy endpoints after enrollment was complete, and the interim safety analysis carries a 0.0001 alpha penalty.