Superiority of a single axitinib implant over a single aflibercept 2 mg injection

“The SOL-1 trial is a prospective, multi-center, double-masked, randomized (1:1), parallel-group, two-arm superiority trial to assess the safety and efficacy of a single injection of AXPAXLI with a drug load of 450 µg of axitinib, or AXPAXLI 450 µg, compared with a single injection of aflibercept 2 mg, in subjects with wet AMD up to Week 52 and repeat-dosing thereafter.” (opens the source at this quote in a new tab)

Durability objective and intended dosing label

“We believe the design of the SOL-1 trial enhances the potential for a 6 - 12 month dosing label for AXPAXLI for the treatment of wet AMD and also provides insights into the long-term durability of AXPAXLI.” (opens the source at this quote in a new tab)

“Compares a single OTX-TKI (0.45 mg) dose to a single aflibercept (2 mg) dose” (opens the source at this quote in a new tab)
“Designed to show superiority on efficacy and durability” (opens the source at this quote in a new tab)

Registry dates

Milestone	Registry record
Study start (actual)	“2024-01-29”
Primary completion (estimated)	“2026-04-29”
Study completion (estimated)	“2027-09-27”

Countries and number of sites

“The SOL-1 trial involves more than 100 trial sites located in the United States and Argentina.” (opens the source at this quote in a new tab)

Registered site countries

Country listed in the registry
“United States”
“Argentina”
“Puerto Rico”

First subjects screened

“today announced that the first three subjects have been screened and received their first aflibercept injection in the Phase 3 SOL-1 clinical trial of AXPAXLI™ (axitinib intravitreal implant, also known as OTX-TKI) for the treatment of wet age-related macular degeneration (wet AMD).” (opens the source at this quote in a new tab)

Completion of randomization and Week 52 database lock

“In December 2024, we completed the randomization of 344 subjects with a diagnosis of wet AMD in the study eye at screening in the SOL-1 trial.” (opens the source at this quote in a new tab)
“As of the Week 52 database lock on February 5, 2026, AXPAXLI was generally well-tolerated in the SOL-1 trial.” (opens the source at this quote in a new tab)

Randomized, double-masked, parallel-group superiority design

“The SOL-1 trial is designed as a prospective, multi-center, double-masked, randomized (1:1), parallel-group, two-arm superiority trial that involves more than 100 trial sites located in the United States and Argentina.” (opens the source at this quote in a new tab)

Registered design details

Design element	Registry record
Allocation	“Randomized”
Interventional model	“Parallel Assignment”
Interventional model description	“1:1”
Masking	“Quadruple”
Collaborators	“Fortrea”
Collaborators	“Duke University”

Eight-week aflibercept loading segment before randomization

“The superiority trial has an eight-week loading segment prior to randomization.” (opens the source at this quote in a new tab)
“This is a population that was specifically selected to lose vision.” (opens the source at this quote in a new tab)

Stratification at randomization

“In addition, the subjects were stratified between the two treatment groups at randomization based on BCVA category (≤ 71 and >71 ETDRS letters) as of the initial screening visit.” (opens the source at this quote in a new tab)

Identical dosing schedules without sham injections

“Both study arms have the same dosing schedule” (opens the source at this quote in a new tab)
“No sham injections in either arm” (opens the source at this quote in a new tab)

Masking and follow-up through Week 104

“In accordance with the trial design, subjects will be followed for safety, and subjects and designated trial personnel will remain masked, through Week 104.” (opens the source at this quote in a new tab)

Special Protocol Assessment agreement and modifications

“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)
“In December 2023, we submitted a first SPA agreement modification to the FDA to broaden the inclusion criteria for subjects in the SOL-1 trial and to reflect our intention to evaluate a single optimized dose of AXPAXLI 450 μg of a more soluble form of axitinib in the trial.” (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)
“In January 2025, we submitted a subsequent SPA agreement modification to the FDA to add a repeat dose of AXPAXLI 450 µg at Week 52 and at Week 76, in each case, after all pre-defined efficacy endpoint assessments, to generate the required safety data for subjects re-dosed with AXPAXLI 450 μg through Week 104, to support long-term dosing.” (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)

Independent rescue monitoring

“Independent rescue monitor team of retina specialists were designated to provide guidance” (opens the source at this quote in a new tab)

Registered inclusion criteria

“Treatment naïve for Neovascular Age-Related Macular Degeneration (nAMD) in either eye at screening.” (opens the source at this quote in a new tab)
“Are at least older than 50 years of age at Day 1.” (opens the source at this quote in a new tab)
“Have Best Corrected Visual Acuity (BCVA) of at least 84 Early Treatment Diabetic Retinopathy Study (ETDRS) letter score (approximate 20/20 Snellen equivalent) at Day 1; OR have an increase of at least 10 ETDRS letters of Best Corrected Visual Acuity (BCVA) from Screening (Visit 1) BCVA” (opens the source at this quote in a new tab)

Registered exclusion criteria

“Monocular subjects or a Best Corrected Visual Acuity (BCVA) score of 20/200 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)

Enrollment and randomization criteria: congress presentation

Stage	Quoted criterion
Enrollment (screening)	“Treatment naïve for nAMD”
Enrollment (screening)	“BCVA ≥54 ETDRS letters (~20/80)”
Enrollment (screening)	“CSFT of ≤500 μm”
Randomization (Day 1)	“BCVA gain ≥10 ETDRS letters OR BCVA ≥84 ETDRS letters (~20/20)”
Randomization (Day 1)	“CSFT of ≤350 μm”

Enrollment and randomization criteria: quarterly report

“had a Best Corrected Visual Acuity, or BCVA, of at least 54 letters as measured by the Early Treatment of Diabetic Retinopathy Study, or ETDRS, letters chart (approximately 20/80 Snellen equivalent vision).” (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)

Enrollment and randomization criteria: topline results announcement

“During the loading segment, subjects who have 20/80 vision or better and a central subfield thickness (CSFT) of ≤500 μm receive two doses of aflibercept (2 mg) at Week -8 and Week -4. Subjects who achieve best corrected visual acuity (BCVA) of 20/20 at Day 1 (baseline) or gain at least 10 Early Treatment Diabetic Retinopathy Study (ETDRS) letters at Day 1 along with a CSFT of ≤350 μm were then randomized to receive a single dose of AXPAXLI or a single dose of aflibercept (2 mg).” (opens the source at this quote in a new tab)

Broadened visual acuity criterion under the first SPA modification

“The SPA Agreement Modification enables the trial to include treatment-naïve wet AMD subjects with visual acuity of approximately 20/80 or better at the initial screening visit.” (opens the source at this quote in a new tab)

Registered interventions

Arm	Registry intervention description
Experimental	“Intravitreal Injection of OTX-TKI (axitinib implant)”
Control	“Injection of 2mg (0.05mL) of aflibercept”

Day 1 treatment and no aflibercept at baseline in the implant arm

“No aflibercept injection is given at baseline” (opens the source at this quote in a new tab)

Optimized 450 µg implant formulation

“The SPA Agreement Modification also allows the pivotal trial to move forward, evaluating AXPAXLI with a single optimized implant with a drug load of 450 µg of a more soluble form of axitinib. This optimized configuration is expected to provide for a slightly increased daily release of the drug and is designed to improve synchronization of axitinib drug depletion with hydrogel bioresorption.” (opens the source at this quote in a new tab)

Monthly visits and redosing at Weeks 52 and 76

“Throughout the trial, subjects are assessed monthly.” (opens the source at this quote in a new tab)
“At Weeks 52 and 76, all subjects that were randomized in the trial at Day 1, including subjects who previously received supplemental anti-VEGF treatment, are re-dosed with their respective initial treatment of a single injection of AXPAXLI 450 μg in the investigational arm or a single injection of aflibercept 2 mg in the control arm.” (opens the source at this quote in a new tab)

Rescue criteria: annual report

“Our pre-specified rescue criteria are a loss of 15 or more letters on the ETDRS chart compared to baseline due to wet AMD, or a new hemorrhage that is deemed to be likely to cause irreversible vision loss due to progression of wet AMD.” (opens the source at this quote in a new tab)

Rescue criteria: congress presentation

“Rescue Criteria: BCVA loss ≥15 ETDRS letters from baseline due to nAMD; or New macular hemorrhage that would likely lead to irreversible vision loss if left untreated in the opinion of the investigator after discussion with Medical Monitor” (opens the source at this quote in a new tab)

Rescue after the first rescue injection

“The protocol provides that after the first rescue injection, rescue therapy may be provided at investigator discretion per their clinical judgement.” (opens the source at this quote in a new tab)

Injector used for administration

“All subjects in two of our Phase 1 trials of AXPAXLI, as well as most of the subjects in the SOL-1 trial and a small subset of subjects in the SOL-R trial were dosed with AXPAXLI using our two-piece injector.” (opens the source at this quote in a new tab)
“As a future lifecycle initiative for AXPAXLI, we may continue development of a next-generation one-piece injector which was used to dose AXPAXLI to a subset of subjects in both the SOL-1 and SOL-R trials.” (opens the source at this quote in a new tab)

Registered outcome measures

Outcome type	Measure	Description	Time frame
Primary	“Best corrected visual acuity (BCVA)”	“Maintenance of visual acuity, defined as < 15 Early Treatment Diabetic Retinopathy Study (ETDRS) letters Best corrected visual acuity (BCVA) loss”	“Up to 36 Weeks”
Other	“Incidence and severity of treatment emergent adverse events (AEs)”	“Changes Safety Outcomes from Baseline”	“Up to 104 Weeks”

Primary endpoint definition and treatment-failure rule

“The primary endpoint is the proportion of subjects who maintain visual acuity, defined as a Best Corrected Visual Acuity, or BCVA, loss of fewer than 15 letters on the Early Treatment of Diabetic Retinopathy Study, or ETDRS, letters chart from baseline at Week 36.” (opens the source at this quote in a new tab)
“The first time a subject is observed to have lost 15 or more ETDRS letters in BCVA in the study eye due to wet AMD at any time up to Week 36 in the trial would be considered as having met the endpoint as a treatment failure.” (opens the source at this quote in a new tab)

Alignment with FDA draft guidance and the SPA agreement

“The SOL-1 primary endpoint was designed to support a potential superiority label in wet AMD based on the FDA’s 2023 draft guidance for wet AMD therapies and was agreed to by the FDA in the Company’s SPA agreement.” (opens the source at this quote in a new tab)

FDA-recommended superiority endpoints at 9 months or later

“Statistically significant smaller % of subjects with ≥15-letter decrease at 9 months or later” (opens the source at this quote in a new tab)
“Statistically significant greater % of subjects with ≥15-letter increase at 9 months or later” (opens the source at this quote in a new tab)
“Statistically significant difference between groups in mean BCVA of ≥15 letters at 9 months or later” (opens the source at this quote in a new tab)
“SOL-1 Primary Endpoint: Proportion of subjects who maintained visual acuity, defined as <15 ETDRS letters of BCVA loss from baseline at Week 36” (opens the source at this quote in a new tab)

Constraints of the SPA agreement

“With acceptance of SPA, study design, endpoints, and SAP cannot be changed” (opens the source at this quote in a new tab)

Key secondary and secondary endpoints in hierarchical order

Endpoint type and order	Quoted endpoint
Key secondary 1	“Proportion of subjects who maintained visual acuity** with one rescue injection or fewer at Week 52”
Key secondary 2	“Proportion of subjects who maintained visual acuity** at Week 52”
Key secondary 3	“Proportion of subjects who maintained visual acuity** with one rescue injection or fewer at Week 36”
Key secondary 4	“BCVA change from baseline at Week 36”
Key secondary 5	“BCVA change from baseline at Week 52”
Secondary 1	“CSFT changes from baseline at Weeks 36”
Secondary 2	“Proportion with no CSFT increase (≤50 microns) at Weeks 36”
Secondary 3	“Proportion CSFT ≤ 350 microns at Weeks 36 and 52”
Secondary 4	“Mean time to the first rescue injection”
Secondary 5	“Mean time to the second rescue injection”
Secondary 6	“Proportion of subjects who lose ≥ 10 letters at Weeks 36 and 52”

Pre-specified exploratory endpoints

“As a pre-specified exploratory endpoint, Ocular evaluated the proportion of patients who did not require rescue injections as specified by the protocol rescue criteria, which includes a BCVA loss of ≥15 ETDRS letters from baseline or new vision-threatening macular hemorrhage.” (opens the source at this quote in a new tab)
“As a pre-specified exploratory endpoint, Ocular evaluated the proportion of subjects maintaining Central Subfield Thickness (CSFT) within 30 μm from baseline.” (opens the source at this quote in a new tab)

Planned sample size

“The trial is intended to randomize approximately 300 evaluable treatment-naïve subjects with a diagnosis of wet AMD in the study eye.” (opens the source at this quote in a new tab)

Registered actual enrollment

Item	Registry record
Enrollment (actual)	“344”

Randomized participants and withdrawals before Day 1 treatment

“In December 2024, the trial completed randomization of 344 treatment-naïve subjects with a diagnosis of wet AMD in the study eye. Two randomized subjects withdrew from the trial prior to receiving Day 1 treatment.” (opens the source at this quote in a new tab)

“In December 2024, the SOL-1 trial completed randomization of 344 evaluable treatment-naïve subjects with a diagnosis of wet AMD in the study eye who have 20/80 vision or better and a central subfield thickness, or CSFT, of not more than 500 µm.” (opens the source at this quote in a new tab)

Participants analyzed by analysis

Analysis	Axitinib implant 0.45 mg	Aflibercept 2 mg
Randomized	“OTX-TKI 0.45 mg N = 172”	“Aflibercept 2 mg N = 172”
Full analysis set (efficacy)	“OTX-TKI 0.45 mg (n=170)”	“Aflibercept 2 mg (n=172)”
Safety tables through Week 52	“OTX-TKI 0.45 mg n = 170”	“Aflibercept 2 mg n = 172”
Screening BCVA quartile 1, post hoc	“OTX-TKI Q1 (n=41)”	“AFL Q1 (n=52)”
Screening BCVA quartile 2, post hoc	“OTX-TKI Q2 (n=39)”	“AFL Q2 (n=39)”
Screening BCVA quartile 3, post hoc	“OTX-TKI Q3 (n=46)”	“AFL Q3 (n=41)”
Screening BCVA quartile 4, post hoc	“OTX-TKI Q4 (n=44)”	“AFL Q4 (n=40)”
Rescue-free participants through Week 36, post hoc	“OTX-TKI 0.45 mg (n=127)”	“Aflibercept 2 mg (n=97)”
Participants with CSFT at Week 8, post hoc	“OTX-TKI 0.45 mg (n=165)”	“Aflibercept 2 mg (n=164)”

Participants exposed to the implant for the planned NDA safety database

“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)

Full analysis set and exclusion of misrandomized participants

“Two OTX-TKI subjects were misrandomized, did not receive study treatment and were not included in the full analysis set” (opens the source at this quote in a new tab)

Handling of treatment discontinuation and statistical model

“Predefined statistical rules were applied to adjust for treatment discontinuation or deviation as per the pre-specified statistical analysis plan.” (opens the source at this quote in a new tab)
“The risk difference is the difference in the probability of maintaining vision in the treatment arm compared to the control arm as per the pre-specified statistical model. The observed difference is the numerical difference of the observed event rate between the two arms.” (opens the source at this quote in a new tab)

Censoring of BCVA and CSFT after first rescue in descriptive analyses

“For subjects who received any rescue injections, their observed BCVA and CSFT values after the 1st rescue injection are set to missing. Baseline measurements are the last non-missing measurement prior to the study drug injection on Day 1.” (opens the source at this quote in a new tab)

Hierarchical testing of key secondary endpoints and sensitivity analyses

“Key secondary endpoints achieved in accordance with the prespecified hierarchy” (opens the source at this quote in a new tab)

“All six pre-specified sensitivity analyses for the SOL-1 primary endpoint at Week 36 were statistically significant, and the first three of five hierarchically controlled key secondary endpoints were also met with statistical significance.” (opens the source at this quote in a new tab)

Rescue-free subgroup definition

“Rescue-free subjects include those who did not require rescue injections as specified by the protocol” (opens the source at this quote in a new tab)

Analysis set for time to CSFT increase

“Subjects with CSFT at Week 8 in Full Analysis Set” (opens the source at this quote in a new tab)

Disposition through Week 52

Disposition item	Axitinib implant 0.45 mg	Aflibercept 2 mg
Randomized	“N=172”	“N=172”
Discontinued before Week 52	“Discontinued before Week 52 (n=11)”	“Discontinued before Week 52 (n=5)”
Adverse event	“Adverse event (n=1)”	“Adverse event (n=2)”
Withdrew consent	“Subject withdrew consent* (n= 6)”	“Subject withdrew consent* (n=1)”
Death	“Death (n=1)”	“Death (n=1)”
Lost to follow-up	“Lost to follow-up (n=1)”	“Lost to follow-up (n=1)”
Completed through Week 52	“n=161 (94%)”	“n=167 (97%)”

Misrandomized participants

“Mis-randomized (n=2)†” (opens the source at this quote in a new tab)
“Subjects did not receive study treatment and were not included in the full analysis set” (opens the source at this quote in a new tab)

Reasons for consent withdrawal

“Reasons included: personal reason, no reason, travel, offered another treatment at a different practice; only Day 1 completed, subject refused week 52 assessment” (opens the source at this quote in a new tab)

Retention and protocol-defined rescues

“Retention in the SOL-1 trial continues to be outstanding, with greater than 95% of randomized subjects remaining on trial to date, and rescues reviewed under masking show greater than 95% of rescue events to date have met pre-established protocol defined criteria.” (opens the source at this quote in a new tab)

Demographics

Characteristic	Axitinib implant 0.45 mg (N = 172)	Aflibercept 2 mg (N = 172)
Age, years, mean (SD)	“75.7 (8.3)”	“76.3 (7.4)”
Female, n (%)	“103 (59.9)”	“108 (62.8)”
Hispanic or Latino, n (%)	“33 (19.2)”	“47 (27.3)”
Not Hispanic or Latino, n (%)	“139 (80.8)”	“125 (72.7)”
White, n (%)	“168 (97.7)”	“170 (98.8)”

Study eye visual acuity and CSFT at screening and baseline

Characteristic	Axitinib implant 0.45 mg (N = 172)	Aflibercept 2 mg (N = 172)
Screening (Week -8) BCVA, ETDRS letters, mean (SD)	“70.9 (11.3)”	“69.5 (10.8)”
Screening (Week -8) CSFT, μm, mean (SD)	“303.6 (72.5)”	“302.7 (78.3)”
Baseline (randomization) BCVA, ETDRS letters, mean (SD)	“80.8 (7.6)”	“79.2 (7.9)”
Baseline (randomization) CSFT, μm, mean (SD)	“219.3 (37.1)”	“226.8 (42.1)”
Change from screening to baseline, ≥10 ETDRS letter gain, n (%)	“107 (62.9)”	“114 (67.1)”
Change from screening to baseline, ≥84 ETDRS letters (~20/20), n (%)	“63 (37.1)”	“56 (32.9)”

Study eye ocular characteristics at baseline

Characteristic	Axitinib implant 0.45 mg (N = 172)	Aflibercept 2 mg (N = 172)
BCVA >71 letters (~ 20/40), stratification category, n (%)	“145 (85.3)”	“136 (79.1)”
Presence of any fluid (IRF and/or SRF), n (%)	“63 (36.6)”	“72 (41.9)”
Presence of IRF, n (%)	“34 (19.8)”	“36 (20.9)”
Presence of SRF, n (%)	“33 (19.2)”	“48 (27.9)”
Presence of hemorrhage, n (%)	“69 (40.6)”	“60 (34.9)”
Phakic, n (%)	“74 (43.5)”	“78 (45.3)”

Baseline macular atrophy

Measure	Axitinib implant 0.45 mg (n=170)	Aflibercept 2 mg (n=172)
Any macular atrophy at baseline	“8.2%”	“7.6%”
Macular atrophy in the central 1 mm at baseline	“1.2%”	“1.2%”

Comparison of baseline visual acuity with other nAMD registration trials

“SOL-1 mean BCVA: 81 letters (~20/25) mean CSFT: 219 μM” (opens the source at this quote in a new tab)
“nAMD Trials mean BCVA: 52 to 62 letters (~20/100 to 20/60)” (opens the source at this quote in a new tab)

Summary: Week 36 and Week 52 efficacy

The primary endpoint was met: at Week 36, 74.1% of participants in the axitinib implant arm (n=170) and 55.8% in the aflibercept 2 mg arm (n=172) maintained vision (model-based risk difference 17.5%, 95% CI 7.7 to 27.4; p=0.0006; observed difference 18.3%). At Week 52, the corresponding proportions were 65.9% and 44.2% (risk difference 21.1%; p<0.0001). The first three of five hierarchically tested key secondary endpoints were met; the fourth and fifth, mean BCVA change from baseline at Weeks 36 and 52, were not reported as met, and no mean BCVA change from baseline values were identified for the full analysis set. Rescue-free rates were 80.6%, 74.7%, and 68.8% at Weeks 24, 36, and 52 with the implant versus 72.1%, 56.4%, and 47.7% with aflibercept. The company describes the rescue-free and CSFT within 30 μm analyses as pre-specified exploratory endpoints in its topline announcement, while congress slides label the same analyses post hoc. Most additional analyses (CSFT time-to-event, screening BCVA quartiles, rescue-free subgroup, treatment burden) are post hoc with descriptive or nominal p-values.

Primary endpoint and Week 52 key secondary endpoint: maintenance of vision

Measure	Week 36 (primary endpoint)	Week 52 (key secondary endpoint)
Axitinib implant 0.45 mg (n = 170), proportion maintaining vision	“74.1%”	“65.9%”
Aflibercept 2 mg (n = 172), proportion maintaining vision	“55.8%”	“44.2%”
Risk difference vs. aflibercept 2 mg	“17.5%”	“21.1%”
95% CI	“(7.7, 27.4)”	“(10.8, 31.4)”
P value	“P = 0.0006”	“P < 0.0001”
Observed difference vs. aflibercept 2 mg	“aflibercept 2 mg 18.3%”	“aflibercept 2 mg 21.7%”

Primary endpoint and Week 52 key secondary endpoint: annual report narrative

“The proportion of subjects who maintained visual acuity, defined as a loss of fewer than 15 ETDRS letters from baseline, at Week 36 was 74.1% in the AXPAXLI arm compared to 55.8% in the aflibercept 2 mg arm, with a risk difference of 17.5% and a p-value of 0.0006 per the pre-specified statistical model, and with an observed difference of 18.3%.” (opens the source at this quote in a new tab)
“The proportion of subjects who maintained vision at Week 52 was 65.9% in the AXPAXLI arm compared to 44.2% in the aflibercept 2 mg arm, with a risk difference of 21.1%, and a p-value of <0.0001 per the pre-specified statistical model compared to aflibercept 2 mg subjects, and with an observed difference of 21.7%.” (opens the source at this quote in a new tab)

Sensitivity analyses of the primary endpoint

“Multiple sensitivity analyses for the primary endpoint were also statistically significant and confirm that the data are robust.” (opens the source at this quote in a new tab)

Key secondary endpoints 1 to 3

Key secondary endpoint	Axitinib implant 0.45 mg (n=170)	Aflibercept 2 mg (n=172)	Risk difference vs. aflibercept	P value
Maintained vision with ≤1 rescue injection at Week 52	“72.4%”	“54.1%”	“17.7% (95% CI, 7.7, 27.8)”	“P = 0.0007”
Maintained vision at Week 52	“65.9%”	“44.2%”	“21.1% (95% CI, 10.8, 31.4)”	“P < 0.0001”
Maintained vision with ≤1 rescue injection at Week 36	“81.2%”	“66.9%”	“13.8% (95% CI, 4.6, 22.9)”	“P = 0.0036”

Key secondary endpoints 4 and 5: BCVA change from baseline

“Strong overall efficacy profile with unmatched durability: Achieved statistical significance in the first three of five key secondary endpoints tested in hierarchical order. In addition, six other pre-specified secondary endpoints measuring clinically significant functional and anatomic outcomes were met with statistical significance.” (opens the source at this quote in a new tab)

Secondary endpoint: proportion with CSFT of 350 μm or less

Timepoint	Axitinib implant 0.45 mg (n=170)	Aflibercept 2 mg (n=172)	Risk difference vs. aflibercept	Nominal p-value
Week 36	“68.8%”	“52.9%”	“15.0% (95% CI, 4.9, 25.1)”	“P = 0.0041*”
Week 52	“64.7%”	“43.6%”	“20.4% (95% CI, 10.1, 30.7)”	“P = 0.0001*”

Secondary endpoint: proportion losing 10 or more ETDRS letters

Timepoint	Axitinib implant 0.45 mg (n=170)	Aflibercept 2 mg (n=172)	Risk difference vs. aflibercept	Nominal p-value
Week 36	“34.1%”	“50.6%”	“-15.9% (95% CI-26.3, -5.6)”	“P = 0.0029*”
Week 52	“47.6%”	“59.3%”	“-10.9% (-21.4, -0.5)”	“P = 0.0423*”

Rescue-free rates: congress presentation, labeled post hoc

Timepoint	Axitinib implant 0.45 mg (n=170)	Aflibercept 2 mg (n=172)	Descriptive p-value
Week 24	“80.6%”	“72.1%”	“P = 0.0856*”
Week 36	“74.7%”	“56.4%”	“P = 0.0006*”
Week 52	“68.8%”	“47.7%”	“P = 0.0001*”

“Post-hoc analysis; Full analysis set; *Descriptive p-values” (opens the source at this quote in a new tab)

Rescue-free rates: quarterly report, with observed differences

“The rescue-free rates in the AXPAXLI arm were 80.6%, 74.7%, and 68.8% at Weeks 24, 36, and 52, respectively, compared to 72.1%, 56.4%, and 47.7% in the aflibercept 2 mg arm at the same time periods. The observed differences were 8.5%, 18.3%, and 21.1% in favor of the AXPAXLI arm at Weeks 24, 36, and 52, respectively.” (opens the source at this quote in a new tab)

Rescue-free rates: rounded values in a later announcement

“Of note, 81% of the AXPAXLI subjects were rescue-free at Week 24.” (opens the source at this quote in a new tab)

Secondary endpoint: time to first rescue treatment

“P = 0.0005*” (opens the source at this quote in a new tab)
“Rescue-free subjects include those who did not require rescue injections as specified by the protocol” (opens the source at this quote in a new tab)

“AXPAXLI Week 52 rescue rate reflects ~6-month advantage over aflibercept” (opens the source at this quote in a new tab)

Rescue-free rate at Week 24 applying SOL-R rescue criteria

“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.” (opens the source at this quote in a new tab)
“The protocol rescue criteria in SOL-R of >5 ETDRS letter loss in BCVA plus a ≥75 μm increase in CSFT are designed to track more closely with real-world clinical practice as compared to the rescue criteria used in SOL-1.” (opens the source at this quote in a new tab)

Rescue-free rate at Week 52 applying SOL-R rescue criteria and estimated injection burden, post hoc

“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. Applying the observed mean rescue treatment rates in SOL-1 to the estimated 33.5% of subjects requiring rescue under the SOL-R criteria corresponded to an average of 0.95 aflibercept (2 mg) rescues per subject for all subjects in the AXPAXLI arm through Week 52 after a single AXPAXLI injection at baseline. 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)

Mean number of expected injections per subject, Week -8 to Week 52	Axitinib implant	Aflibercept 2 mg (projected)	Injection burden reduction
Excluding loading doses	“1.95”	“7.00”	“72”
Including loading doses	“3.95”	“9.00”	“56”

CSFT maintained within 30 μm of baseline: topline announcement, labeled pre-specified exploratory

“Week 36: 55.9% of subjects treated with AXPAXLI maintained CSFT within 30 μm from baseline versus 37.8% of subjects in the aflibercept (2 mg) arm, representing a risk difference of 17.1% in favor of AXPAXLI (nominal p=0.0013).” (opens the source at this quote in a new tab)
“Week 52: 44.1% of subjects treated with AXPAXLI maintained CSFT within 30 μm from baseline versus 34.9% of subjects in the aflibercept (2 mg) arm, representing a risk difference of 8.4% in favor of AXPAXLI (nominal p=0.1094).” (opens the source at this quote in a new tab)

CSFT increase of 30 μm or less from baseline: congress presentation, labeled post hoc

Timepoint	Axitinib implant 0.45 mg (n=170)	Aflibercept 2 mg (n=172)	Risk difference vs. aflibercept	Descriptive p-value
Week 24	“51.8%”	“40.1%”	“11.0% (95% CI, 0.6, 21.5)”	“P = 0.0403*”
Week 36	“55.9%”	“37.8%”	“17.1% (95% CI, 6.8, 27.4)”	“P = 0.0013*”
Week 52	“44.1%”	“34.9%”	“8.4% (95% CI, -1.8, 18.7)”	“P = 0.1094*”

“Full analysis set. Post hoc analysis; *Descriptive p-value” (opens the source at this quote in a new tab)

Time to CSFT increase from Week 8, post hoc: announcement and congress presentation

“The median time to ≥30 uM Central Subfield Thickness (CSFT) increase from Week 8 was 39 weeks in the AXPAXLI group and 16 weeks in the aflibercept (2 mg) group, a 23-week difference. An estimated hazard ratio of 0.7 indicates that, at any time from Week 8 to Week 52, subjects in the treatment group experienced a 30% lower risk of the event (descriptive p=0.0028) compared with the control group.” (opens the source at this quote in a new tab)
“The median time to ≥75 uM CSFT increase from Week 8 was 46 weeks in the AXPAXLI group and 24 weeks in the aflibercept (2 mg) group, a 22-week difference. An estimated hazard ratio of 0.5 indicates that, at any time from Week 8 to Week 52, subjects in the treatment group experienced a 50% lower risk of the event (descriptive p<0.0001) compared with the control group.” (opens the source at this quote in a new tab)

Time to CSFT increase of 30 μm or more from Week 8: investor presentation reporting a different p-value

“~6-month difference in time to a 30 μm CSFT gain in favor of AXPAXLI suggests exceptional disease control” (opens the source at this quote in a new tab)
“P < 0.0001*” (opens the source at this quote in a new tab)

Mean BCVA and CSFT change from screening through Week 36, post hoc

Measure	Axitinib implant 0.45 mg (n=170)	Aflibercept 2 mg (n=172)
BCVA change from screening at Week 24, ETDRS letters	“+6.5”	“+4.9”
BCVA change from screening at Week 36, ETDRS letters	“+6.6”	“+5.4”
CSFT change from screening at Week 24, μm	“-43.0”	“-32.6”
CSFT change from screening at Week 36, μm	“-59.0”	“-31.7”

Mean BCVA and CSFT at Week 36, post hoc

Measure	Axitinib implant 0.45 mg (n=170)	Aflibercept 2 mg (n=172)
Mean BCVA at baseline, ETDRS letters	“80.8”	“79.2”
Mean BCVA at Week 36, ETDRS letters	“78.0”	“76.6”
Mean CSFT at baseline, μm	“219.3”	“226.8”
Mean CSFT at Week 36, μm	“238.3”	“258.0”

Mean change in total intraretinal and subretinal fluid volume from baseline: values as labeled in each presentation

Timepoint	Axitinib implant 0.45 mg (n=170)	Aflibercept 2 mg (n=172)
Week 24	“+31.1”	“+49.5”
Week 36	“+30.6”	“+54.0”

Timepoint	Axitinib implant 0.45 mg (n=170)	Aflibercept 2 mg (n=172)
Week 24	“32 nL”	“54 nL”
Week 36	“31 nL”	“59 nL”

Timepoint	Axitinib implant 0.45 mg (n=170)	Aflibercept 2 mg (n=172)
Week 36	“31 nL”	“59 nL”

Maintenance of vision at Week 36 by baseline fluid status

Subgroup	Axitinib implant	Aflibercept 2 mg	Risk difference (95% CI)
Overall	“74.1%”	“55.8%”	“17.5 (7.7, 27.4)”
IRF/SRF absent	“80.4%”	“56.0%”	“23.5 (11.1, 35.9)”
IRF/SRF present	“63.5%”	“55.6%”	“9.1 (-7.1, 25.3)”
IRF absent	“77.2%”	“57.4%”	“18.3 (7.4, 29.2)”
IRF present	“61.8%”	“50.0%”	“12.4 (-11.1, 36.0)”
SRF absent	“76.6%”	“56.5%”	“19.4 (8.2, 30.7)”
SRF present	“63.6%”	“54.2%”	“9.8 (-11.1, 30.8)”

BCVA by screening BCVA quartile, post hoc

“For example, AXPAXLI subjects in the lowest vision quartile group at screening had the greatest visual gains with +11.8 ETDRS letters compared to +8.5 letters in the aflibercept (2 mg) arm at Week 52. The mean vision at screening in this arm is similar to baseline BCVA in prior wet AMD studies. In comparison, subjects in the best vision quartile at screening had essentially no change in vision at Week 52 (-0.5 vs +1.1 letters; AXPAXLI vs aflibercept) as they started with almost 20/20 vision.” (opens the source at this quote in a new tab)

Quartile	Mean screening BCVA, axitinib implant	Mean screening BCVA, aflibercept 2 mg
Quartile 1	“55.5”	“56.8”
Quartile 2	“67.2”	“66.3”
Quartile 3	“75.7”	“75.7”
Quartile 4	“83.6”	“82.7”

BCVA change in rescue-free participants, post hoc

“Observed difference for change in BCVA from baseline at Week 24 in the rescue-free subjects was -1.9 ETDRS letters in the AXPAXLI arm (+7.5 letters from screening) vs -2.6 letters in the aflibercept arm (+6.0 letters from screening).” (opens the source at this quote in a new tab)
“At Week 36, 75% of AXPAXLI subjects remained rescue-free and lost <1 additional letter from Week 24 (+6.6 letters from screening).” (opens the source at this quote in a new tab)

Observed BCVA change from baseline in rescue-free participants, ETDRS letters	Axitinib implant (n=127) and aflibercept 2 mg (n=97)
Week 24	“24w -1.9 -2.6”
Week 36	“36w -2.8 -2.9”

Persistence of vision maintenance from Month 9 to Month 12, post hoc

“Of subjects that maintained vision at Month 9, ~90% maintained vision at Month 12” (opens the source at this quote in a new tab)

Health-related quality of life and patient-reported outcomes

No evidence found.

Summary: safety through Week 52

Through Week 52, ocular adverse events in the study eye occurred in 90 of 170 participants (52.9%) receiving the axitinib implant and 58 of 172 (33.7%) receiving aflibercept 2 mg; treatment-related ocular adverse events occurred in 15 (8.8%) and 1 (0.6%). One ocular serious adverse event (0.6%) occurred in the implant arm (severe vision loss due to posterior subcapsular cataract) and none were treatment related. Vitreous floaters were reported in 21 participants (12.4%) with the implant and 2 (1.2%) with aflibercept. Intraocular inflammation was reported as 9 events in 7 participants (4.1%) in the implant arm, all mild or moderate and resolved. No endophthalmitis, occlusive or non-occlusive retinal vasculitis, retinal detachment, or implant migration to the anterior chamber was reported in the implant arm. No intraocular pressure data and no Year 2 (post-redosing) safety data were identified.

Overview of adverse events through Week 52

Participants with AEs through Week 52, n (%)	Axitinib implant 0.45 mg (n = 170)	Aflibercept 2 mg (n = 172)
Non-ocular: ≥1 AE	“84 (49.4)”	“73 (42.4)”
Non-ocular: ≥1 SAE	“19 (11.2)”	“21 (12.2)”
Non-ocular: ≥1 study procedure-related AE	“1 (0.6)”	“0”
AE leading to study discontinuation	“3 (1.8)”	“3 (1.7)”
AE leading to death	“2 (1.2)”	“1 (0.6)”
Ocular, study eye: ≥1 AE	“90 (52.9)”	“58 (33.7)”
Ocular, study eye: ≥1 SAE	“1 (0.6)”	“0”
Ocular, study eye: ≥1 treatment-related AE	“15 (8.8)”	“1 (0.6)”
Ocular, study eye: ≥1 study procedure-related AE	“15 (8.8)”	“7 (4.1)”
Ocular AE leading to study discontinuation	“0”	“0”

Deaths and the ocular serious adverse event

“Stroke (day 103); worsening of metastatic melanoma (day 319); lung cancer metastatic (day 503)” (opens the source at this quote in a new tab)
“Severe vision loss due to 3+ PSC cataract, 78 ETDRS letters at baseline, recovered to 70 ETDRS letters after cataract surgery” (opens the source at this quote in a new tab)

Ocular adverse events in the study eye in more than 2% of participants

Adverse event, n (%)	Axitinib implant 0.45 mg (n = 170)	Aflibercept 2 mg (n = 172)
Vitreous floaters	“21 (12.4)”	“2 (1.2)”
Cataract	“12 (7.1)”	“5 (2.9)”
Conjunctival hemorrhage	“11 (6.5)”	“5 (2.9)”
Retinal hemorrhage	“10 (5.9)”	“17 (9.9)”
Dry eye	“7 (4.1)”	“2 (1.2)”
Vitreous detachment	“7 (4.1)”	“3 (1.7)”
Punctate keratitis	“6 (3.5)”	“0”
Vitreous opacities	“6 (3.5)”	“0”
Eye pain	“5 (2.9)”	“1 (0.6)”
Anterior chamber opacity	“4 (2.4)”	“0”
Posterior capsule opacification	“4 (2.4)”	“6 (3.5)”

Endophthalmitis, retinal vasculitis, retinal detachment, and implant migration

“As of the Week 52 database lock on February 5, 2026, AXPAXLI was generally well-tolerated in SOL-1 with no observed treatment-related ocular or systemic serious adverse events (SAEs). There were no events of endophthalmitis, occlusive or non-occlusive retinal vasculitis, retinal detachment, or implant migration to the anterior chamber observed in the AXPAXLI arm.” (opens the source at this quote in a new tab)

“There were no cases of endophthalmitis, occlusive or non-occlusive retinal vasculitis, confirmed by wide-field fluorescein angiography in uveitis cases (Reading Center graded)” (opens the source at this quote in a new tab)

Intraocular inflammation

“Nine events observed in 7 subjects in the OTX-TKI arm” (opens the source at this quote in a new tab)
“8 events treated with topical corticosteroids and resolved” (opens the source at this quote in a new tab)
“1 event (vitreous cells), mild in severity, resolved without treatment” (opens the source at this quote in a new tab)

Participant	MedDRA term	Eye	Severity	Medication
1	“Iritis”	“Study eye”	“Mild”	“Topical corticosteroids”
1	“Iritis”	“Study eye”	“Moderate”	“Topical corticosteroids”
2	“Iridocyclitis”	“Study eye”	“Mild”	“Topical corticosteroids”
3	“AC inflammation”	“Study eye”	“Moderate”	“Topical corticosteroids”
4	“Vitreal cells”	“Study eye”	“Mild”	“None”
5	“Iritis”	“Study eye”	“Mild”	“Topical corticosteroids”
6	“Eye inflammation”	“Study eye”	“Moderate”	“Topical corticosteroids”
7	“Iritis”	“Study eye”	“Mild”	“Topical corticosteroids”
7	“Uveitis”	“Study Eye”	“Moderate”	“Topical corticosteroids”
7	“Uveitis”	“Non-study eye”	“Mild”	“None”

Vitreous floaters: onset and effect on vision

Measure	Axitinib implant 0.45 mg (n = 23 events)	Aflibercept 2 mg (n = 2)
Time to onset, days, mean (SD)	“187.9 (64.0)”	“164.5 (164.8)”
Time to onset, days, median	“207.0”	“164.5”
BCVA change from prior visit before onset, ETDRS letters, mean (SD)	“-0.4 (5.0)”	“-5.5 (6.4)”

“23 events in the study eye, 21 subjects; No case observed to be associated with cataract formation” (opens the source at this quote in a new tab)
“OTK-TKI: Mean change from baseline (SD) in BCVA, -3.3 (8.2) ETDRS letters; median change from baseline, -1.0 ETDRS letters” (opens the source at this quote in a new tab)

“In all AXPAXLI subjects who had a vitreous floater AE, drug particles are no longer visible (mean time of 20 weeks)” (opens the source at this quote in a new tab)

Incidence of macular atrophy at Week 52

Measure	Axitinib implant 0.45 mg (n=170)	Aflibercept 2 mg (n=172)
Any macular atrophy at Week 52	“9.4%”	“10.3%”
Any macular atrophy, percent change from baseline	“OTX-TKI 0.45mg: 1.2%”	“Aflibercept 2 mg: 2.7%”
Macular atrophy in the central 1 mm at Week 52	“1.9%”	“1.8%”
Macular atrophy in the central 1 mm, percent change from baseline	“OTX-TKI 0.45mg: 0.7%”	“Aflibercept 2 mg: 0.6%”

Intraocular pressure

No evidence found.

Year 2 safety after redosing

“Masked safety data being monitored and DSMC recommends trial continuation” (opens the source at this quote in a new tab)

“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)

Summary

SOL-1 compared a single axitinib implant with a single aflibercept 2 mg injection rather than with aflibercept at its labeled every-8-week maintenance schedule, so the superiority result reflects durability after one dose of each agent, not comparative effectiveness against labeled anti-VEGF regimens; the treatment burden reduction versus on-label aflibercept is a post hoc projection that the company describes as illustrative. Enrollment was limited to treatment-naive eyes that responded to two aflibercept loading doses, and mean baseline BCVA was 80.8 and 79.2 ETDRS letters (approximately 20/25), compared with 52 to 62 letters in other nAMD registration trials; results may not apply to eyes with poorer vision, incomplete loading response, or prior treatment. Race was 97.7% and 98.8% White in the two arms. The primary endpoint is a responder definition (loss of fewer than 15 letters) under which aflibercept-treated participants were eligible for rescue; key secondary endpoints for mean BCVA change from baseline at Weeks 36 and 52 were not among the endpoints reported as met, and mean BCVA change values from baseline for the full analysis set were not identified. Several analyses highlighted by the company (rescue-free rates, CSFT within 30 μm, time to CSFT increase, quartile and rescue-free subgroups) are post hoc or exploratory with nominal p-values, and sources disagree on whether the rescue-free and CSFT analyses were pre-specified, on the p-value for time to a 30 μm CSFT increase (0.0028 versus less than 0.0001), and on the aflibercept retinal fluid volume change at Week 36 (54.0 versus 59 nL). All results available as of September 2026 are company press releases, SEC filings, and company-hosted congress slides; no peer-reviewed publication or registry results were identified, and the registry record was last updated in April 2025. Safety data cover 170 implant-treated participants through Week 52 after a single dose; data after redosing at Weeks 52 and 76, intraocular pressure data, and long-term safety are not yet reported, and vitreous floaters (12.4%) and intraocular inflammation (7 participants) were more frequent with the implant.