Corneal Edema, Corneal Endothelial Dysfunction
Conditions
Brief summary
The goal of this clinical trial is to compare different doses of AURN001 in patients with corneal edema secondary to corneal endothelial dysfunction. The main questions the clinical trial aims to answer are whether AURN001 effective and safe. Participants will receive a single injection of AURN001. A comparison between low, medium, and high doses of AURN001 against the contribution of each element, cells alone and Y27632 alone, will be conducted to determine the effects on corneal edema.
Interventions
COMBINATION_PRODUCTAURN001
Corneal Endothelial Cells and Y27632
BIOLOGICALCorneal Endothelial Cells
Corneal Endothelial Cells
DRUGY27632
Y27632
Sponsors
Aurion Biotech
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Have a diagnosis of corneal edema secondary to corneal endothelial dysfunction, requiring surgery (full- or partial-thickness endothelial keratoplasty) * BCVA between 65 Early Treatment of Diabetic Retinopathy Study (ETDRS) letters (i.e., 0.4 LogMAR or approximate 20/50 Snellen equivalent) and 5 ETDRS letters (i.e., 1.6 LogMAR or approximate 20/800 Snellen equivalent)
Exclusion criteria
* Have pre-operative corneal epithelial, sub-epithelial or stromal scarring or other opacity that is paracentral/central and visually significant, but not suspected to be secondary to corneal endothelial disease with the potential to improve from treatment in the study eye * Have history or presence of an ocular disease other than corneal endothelial dysfunction that could affect vision or safety assessments
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving ≥15-letter Improvement in Best-corrected Visual Acuity (BCVA) at Month 6 - Imputed Data | Month 6 | Best-corrected visual acuity was assessed using Early Treatment Diabetic Retinopathy Study(ETDRS) method, standard for vision testing. Standardized Sloan letter charts with 5 letters per line, decreasing by 0.1 logarithm of minimum angle of resolution (LogMAR) per line, were used at 4 meters (or 1 meter if ≤19 letters were read, with +0.75 spherical power added). Each correct letter equaled one point (0.02 LogMAR), with 85 letters (0.0 LogMAR) corresponding to 20/20 Snellen, 70 letters (+0.3) to 20/40, and 35 letters (+1.0) to 20/200. A gain of ≥15 letters (0.3 LogMAR, 3 lines) was clinically meaningful. Data from the study eye only were included in the analysis. Participants read letters aloud, guessing encouraged, and all responses recorded for accuracy. Data presented represent number of participants with available BCVA measurements at Month 6, with those who had missing data, underwent rescue surgery before Month 6, or discontinued study prior to Month 6 imputed as non-responders. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Central Corneal Thickness (CCT) at Month 6 | Baseline (Day 1) and at Month 6 | Central corneal thickness was measured by pachymetry which is an essential anatomical marker for detecting the presence or absence of edema and serves as a supportive indicator of treatment efficacy. Baseline was defined as the last measurement prior to the study drug injection on Day 1. Change from baseline values was calculated as follow-up visit minus baseline visit. |
| Percentage of Participants Achieving ≥15-letter Improvement in BCVA at All Timepoints - Observed Data | At Week 4 and at Months 2, 3, 4.5, 6, 9 and 12 | Best-corrected visual acuity was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) method, the standard for vision testing. Standardized Sloan letter charts with five letters per line, decreasing by 0.1 logarithm of the minimum angle of resolution (LogMAR) per line, were used at 4 meters (or 1 meter if ≤19 letters were read, with +0.75 spherical power added). Each correct letter equaled one point (0.02 LogMAR), with 85 letters (0.0 LogMAR) corresponding to 20/20 Snellen, 70 letters (+0.3) to 20/40, and 35 letters (+1.0) to 20/200. A gain of ≥15 letters (0.3 LogMAR, 3 lines) was clinically meaningful. Data from the study eye only were included in the analysis. Participants read letters aloud, guessing encouraged, and all responses recorded for accuracy. The data presented reflect only participants with non-missing BCVA at each corresponding visit. |
| Change From Baseline in BCVA at Month 6 | Baseline (Day 1) and at Month 6 | Best-corrected visual acuity was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) method, the standard for vision testing. Standardized Sloan letter charts with five letters per line, decreasing by 0.1 logarithm of the minimum angle of resolution (LogMAR) per line, were used at 4 meters (or 1 meter if ≤19 letters were read, with +0.75 spherical power added). Each correct letter equaled one point (0.02 LogMAR), with 85 letters (0.0 LogMAR) corresponding to 20/20 Snellen, 70 letters (+0.3) to 20/40, and 35 letters (+1.0) to 20/200. A gain of ≥15 letters (0.3 LogMAR, 3 lines) was clinically meaningful. Data from the study eye only were included in the analysis. Participants read letters aloud, guessing encouraged, and all responses recorded for accuracy. Baseline was defined as the last measurement prior to the study drug injection on Day 1. Change from baseline values was calculated as follow-up visit minus baseline visit. |
| Change From Baseline in CCT at All Other Timepoints | Baseline (Day 1) and at Weeks 1 and 4, Months 2, 3, 4.5, 6, 9, and 12 | Central corneal thickness was measured by pachymetry which is an essential anatomical marker for detecting the presence or absence of edema and serves as a supportive indicator of treatment efficacy. Baseline was defined as the last measurement prior to the study drug injection on Day 1. Change from baseline values was calculated as follow-up visit minus baseline visit. |
| Percentage of Participants Achieving ≥10-letter Improvement in BCVA at All Timepoints - Observed Data | At Week 4 and at Months 2, 3, 4.5, 6, 9 and 12 | Best-corrected visual acuity was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) method, the standard for vision testing. Standardized Sloan letter charts with five letters per line, decreasing by 0.1 logarithm of the minimum angle of resolution (LogMAR) per line, were used at 4 meters (or 1 meter if ≤19 letters were read, with +0.75 spherical power added). Each correct letter equaled one point (0.02 LogMAR), with 85 letters (0.0 LogMAR) corresponding to 20/20 Snellen, 70 letters (+0.3) to 20/40, and 35 letters (+1.0) to 20/200. A gain of ≥15 letters (0.3 LogMAR, 3 lines) was clinically meaningful. Data from the study eye only were included in the analysis. Participants read letters aloud, guessing encouraged, and all responses recorded for accuracy. The data presented reflect only participants with non-missing BCVA at each corresponding visit. |
| Change From Baseline in BCVA at All Other Timepoints | Baseline (Day 1) and at Week 4, Months 2, 3, 4.5, 6, 9 and 12 | Best-corrected visual acuity was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) method, the standard for vision testing. Standardized Sloan letter charts with five letters per line, decreasing by 0.1 logarithm of the minimum angle of resolution (LogMAR) per line, were used at 4 meters (or 1 meter if ≤19 letters were read, with +0.75 spherical power added). Each correct letter equaled one point (0.02 LogMAR), with 85 letters (0.0 LogMAR) corresponding to 20/20 Snellen, 70 letters (+0.3) to 20/40, and 35 letters (+1.0) to 20/200. A gain of ≥15 letters (0.3 LogMAR, 3 lines) was clinically meaningful. Data from the study eye only were included in the analysis. Participants read letters aloud, guessing encouraged, and all responses recorded for accuracy. Baseline was defined as the last measurement prior to the study drug injection on Day 1. Change from baseline values was calculated as follow-up visit minus baseline visit. |
Countries
Canada, United States
Participant flow
Recruitment details
This was a multicenter, randomized, double-masked, parallel-arm, dose-ranging Phase 1/2 study evaluating safety, efficacy, and tolerability of AURN001 in participants with corneal edema due to endothelial dysfunction. Three dose levels were compared with neltependocel and Y-27632 alone to assess each component's contribution on efficacy and safety of AURN001.
Pre-assignment details
A total of 97 participants were enrolled and received the study treatment.
Participants by arm
| Arm | Count |
|---|---|
| Y-27632 100 µM Participants received a single intracameral injection of Y-27632 (100 Micromolar \[μM\]) under local anesthesia. | 21 |
| Neltependocel 1.0 × 10^6 Participants received a single intracameral injection of neltependocel 1.0 × 10\^6 cells under local anesthesia. | 18 |
| AURN001 (2.5 × 10^5 Neltependocel + Y-27632 100 µM) Participants received a single intracameral injection of neltependocel 2.5 × 10\^5 cells administered with Y-27632 100 μM under local anesthesia. | 19 |
| AURN001 (5.0 × 10^5 Neltependocel + Y-27632 100 µM) Participants received a single intracameral injection of neltependocel 5.0 × 10\^5 cells administered with Y-27632 100 μM under local anesthesia. | 19 |
| AURN001 (1.0 × 10^6 Neltependocel + Y-27632 100 µM) Participants received a single intracameral injection of neltependocel 1.0 × 10\^6 cells administered with Y-27632 100 μM under local anesthesia. | 20 |
| Total | 97 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Rescue | 17 | 6 | 9 | 6 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 3 | 1 | 1 |
Baseline characteristics
| Characteristic | Y-27632 100 µM | Neltependocel 1.0 × 10^6 | AURN001 (2.5 × 10^5 Neltependocel + Y-27632 100 µM) | AURN001 (5.0 × 10^5 Neltependocel + Y-27632 100 µM) | AURN001 (1.0 × 10^6 Neltependocel + Y-27632 100 µM) | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 70.3 Years STANDARD_DEVIATION 9.59 | 71.3 Years STANDARD_DEVIATION 9.93 | 74.7 Years STANDARD_DEVIATION 10.32 | 69.3 Years STANDARD_DEVIATION 6.91 | 71.6 Years STANDARD_DEVIATION 8.28 | 71.4 Years STANDARD_DEVIATION 9.08 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants | 17 Participants | 18 Participants | 17 Participants | 20 Participants | 93 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 18 Participants | 17 Participants | 15 Participants | 18 Participants | 19 Participants | 87 Participants |
| Sex: Female, Male Female | 11 Participants | 14 Participants | 10 Participants | 5 Participants | 15 Participants | 55 Participants |
| Sex: Female, Male Male | 10 Participants | 4 Participants | 9 Participants | 14 Participants | 5 Participants | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 18 | 0 / 19 | 0 / 19 | 0 / 20 |
| other Total, other adverse events | 9 / 21 | 11 / 18 | 10 / 19 | 18 / 19 | 14 / 20 |
| serious Total, serious adverse events | 1 / 21 | 1 / 18 | 0 / 19 | 0 / 19 | 0 / 20 |
Outcome results
Primary
Percentage of Participants Achieving ≥15-letter Improvement in Best-corrected Visual Acuity (BCVA) at Month 6 - Imputed Data
Best-corrected visual acuity was assessed using Early Treatment Diabetic Retinopathy Study(ETDRS) method, standard for vision testing. Standardized Sloan letter charts with 5 letters per line, decreasing by 0.1 logarithm of minimum angle of resolution (LogMAR) per line, were used at 4 meters (or 1 meter if ≤19 letters were read, with +0.75 spherical power added). Each correct letter equaled one point (0.02 LogMAR), with 85 letters (0.0 LogMAR) corresponding to 20/20 Snellen, 70 letters (+0.3) to 20/40, and 35 letters (+1.0) to 20/200. A gain of ≥15 letters (0.3 LogMAR, 3 lines) was clinically meaningful. Data from the study eye only were included in the analysis. Participants read letters aloud, guessing encouraged, and all responses recorded for accuracy. Data presented represent number of participants with available BCVA measurements at Month 6, with those who had missing data, underwent rescue surgery before Month 6, or discontinued study prior to Month 6 imputed as non-responders.
Time frame: Month 6
Population: Full Analysis Set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Y-27632 100 µM | Percentage of Participants Achieving ≥15-letter Improvement in Best-corrected Visual Acuity (BCVA) at Month 6 - Imputed Data | 14.3 Percentage of participants |
| Neltependocel (1.0 × 10^6) | Percentage of Participants Achieving ≥15-letter Improvement in Best-corrected Visual Acuity (BCVA) at Month 6 - Imputed Data | 44.4 Percentage of participants |
| AURN001 (2.5 × 10^5 Neltependocel + Y-27632 100 µM) | Percentage of Participants Achieving ≥15-letter Improvement in Best-corrected Visual Acuity (BCVA) at Month 6 - Imputed Data | 10.5 Percentage of participants |
| AURN001 (5.0 × 10^5 Neltependocel + Y-27632 100 µM) | Percentage of Participants Achieving ≥15-letter Improvement in Best-corrected Visual Acuity (BCVA) at Month 6 - Imputed Data | 36.8 Percentage of participants |
| AURN001 (1.0 × 10^6 Neltependocel + Y-27632 100 µM) | Percentage of Participants Achieving ≥15-letter Improvement in Best-corrected Visual Acuity (BCVA) at Month 6 - Imputed Data | 50.0 Percentage of participants |
p-value: 0.072295% CI: [0.8, 58.3]Fisher Exact
p-value: >0.999995% CI: [-28.1, 20.6]Fisher Exact
p-value: 0.148295% CI: [-5.5, 50.6]Fisher Exact
p-value: 0.020395% CI: [5.9, 61.6]Fisher Exact
p-value: 0.029395% CI: [-60.3, -4.6]Fisher Exact
p-value: 0.743195% CI: [-38.9, 25.3]Fisher Exact
p-value: 0.756895% CI: [-26.8, 37.3]Fisher Exact
Secondary
Change From Baseline in BCVA at All Other Timepoints
Best-corrected visual acuity was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) method, the standard for vision testing. Standardized Sloan letter charts with five letters per line, decreasing by 0.1 logarithm of the minimum angle of resolution (LogMAR) per line, were used at 4 meters (or 1 meter if ≤19 letters were read, with +0.75 spherical power added). Each correct letter equaled one point (0.02 LogMAR), with 85 letters (0.0 LogMAR) corresponding to 20/20 Snellen, 70 letters (+0.3) to 20/40, and 35 letters (+1.0) to 20/200. A gain of ≥15 letters (0.3 LogMAR, 3 lines) was clinically meaningful. Data from the study eye only were included in the analysis. Participants read letters aloud, guessing encouraged, and all responses recorded for accuracy. Baseline was defined as the last measurement prior to the study drug injection on Day 1. Change from baseline values was calculated as follow-up visit minus baseline visit.
Time frame: Baseline (Day 1) and at Week 4, Months 2, 3, 4.5, 6, 9 and 12
Population: Full Analysis Set. Only those participants with data available at specified time points has been presented.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Y-27632 100 µM | Change From Baseline in BCVA at All Other Timepoints | Week 4 | -28.7 change in ETDRS letters | Standard Deviation 24.57 |
| Y-27632 100 µM | Change From Baseline in BCVA at All Other Timepoints | Month 12 | -21.5 change in ETDRS letters | Standard Deviation 28 |
| Y-27632 100 µM | Change From Baseline in BCVA at All Other Timepoints | Month 9 | -21.4 change in ETDRS letters | Standard Deviation 28.15 |
| Y-27632 100 µM | Change From Baseline in BCVA at All Other Timepoints | Month 6 | -21.2 change in ETDRS letters | Standard Deviation 28.63 |
| Y-27632 100 µM | Change From Baseline in BCVA at All Other Timepoints | Month 3 | -19.6 change in ETDRS letters | Standard Deviation 25.82 |
| Y-27632 100 µM | Change From Baseline in BCVA at All Other Timepoints | Month 4.5 | -21.2 change in ETDRS letters | Standard Deviation 26.51 |
| Y-27632 100 µM | Change From Baseline in BCVA at All Other Timepoints | Month 2 | -17.2 change in ETDRS letters | Standard Deviation 21.69 |
| Neltependocel (1.0 × 10^6) | Change From Baseline in BCVA at All Other Timepoints | Month 12 | -1.2 change in ETDRS letters | Standard Deviation 40.29 |
| Neltependocel (1.0 × 10^6) | Change From Baseline in BCVA at All Other Timepoints | Month 6 | -5.6 change in ETDRS letters | Standard Deviation 40.48 |
| Neltependocel (1.0 × 10^6) | Change From Baseline in BCVA at All Other Timepoints | Month 9 | -5.5 change in ETDRS letters | Standard Deviation 41.19 |
| Neltependocel (1.0 × 10^6) | Change From Baseline in BCVA at All Other Timepoints | Month 2 | -20.5 change in ETDRS letters | Standard Deviation 37.31 |
| Neltependocel (1.0 × 10^6) | Change From Baseline in BCVA at All Other Timepoints | Week 4 | -24.6 change in ETDRS letters | Standard Deviation 33.16 |
| Neltependocel (1.0 × 10^6) | Change From Baseline in BCVA at All Other Timepoints | Month 3 | -8.1 change in ETDRS letters | Standard Deviation 40.76 |
| Neltependocel (1.0 × 10^6) | Change From Baseline in BCVA at All Other Timepoints | Month 4.5 | -8.9 change in ETDRS letters | Standard Deviation 39.8 |
| AURN001 (2.5 × 10^5 Neltependocel + Y-27632 100 µM) | Change From Baseline in BCVA at All Other Timepoints | Week 4 | -27.8 change in ETDRS letters | Standard Deviation 29.64 |
| AURN001 (2.5 × 10^5 Neltependocel + Y-27632 100 µM) | Change From Baseline in BCVA at All Other Timepoints | Month 2 | -26.6 change in ETDRS letters | Standard Deviation 29.37 |
| AURN001 (2.5 × 10^5 Neltependocel + Y-27632 100 µM) | Change From Baseline in BCVA at All Other Timepoints | Month 12 | -14.3 change in ETDRS letters | Standard Deviation 26.16 |
| AURN001 (2.5 × 10^5 Neltependocel + Y-27632 100 µM) | Change From Baseline in BCVA at All Other Timepoints | Month 9 | -13.1 change in ETDRS letters | Standard Deviation 26.36 |
| AURN001 (2.5 × 10^5 Neltependocel + Y-27632 100 µM) | Change From Baseline in BCVA at All Other Timepoints | Month 4.5 | -11.6 change in ETDRS letters | Standard Deviation 26.97 |
| AURN001 (2.5 × 10^5 Neltependocel + Y-27632 100 µM) | Change From Baseline in BCVA at All Other Timepoints | Month 6 | -15.2 change in ETDRS letters | Standard Deviation 25.26 |
| AURN001 (2.5 × 10^5 Neltependocel + Y-27632 100 µM) | Change From Baseline in BCVA at All Other Timepoints | Month 3 | -10.6 change in ETDRS letters | Standard Deviation 22.64 |
| AURN001 (5.0 × 10^5 Neltependocel + Y-27632 100 µM) | Change From Baseline in BCVA at All Other Timepoints | Month 6 | -3.9 change in ETDRS letters | Standard Deviation 28.3 |
| AURN001 (5.0 × 10^5 Neltependocel + Y-27632 100 µM) | Change From Baseline in BCVA at All Other Timepoints | Week 4 | -26.9 change in ETDRS letters | Standard Deviation 25.04 |
| AURN001 (5.0 × 10^5 Neltependocel + Y-27632 100 µM) | Change From Baseline in BCVA at All Other Timepoints | Month 2 | -24.3 change in ETDRS letters | Standard Deviation 27.63 |
| AURN001 (5.0 × 10^5 Neltependocel + Y-27632 100 µM) | Change From Baseline in BCVA at All Other Timepoints | Month 3 | -9.2 change in ETDRS letters | Standard Deviation 27.96 |
| AURN001 (5.0 × 10^5 Neltependocel + Y-27632 100 µM) | Change From Baseline in BCVA at All Other Timepoints | Month 4.5 | -4.1 change in ETDRS letters | Standard Deviation 28.07 |
| AURN001 (5.0 × 10^5 Neltependocel + Y-27632 100 µM) | Change From Baseline in BCVA at All Other Timepoints | Month 9 | -3.8 change in ETDRS letters | Standard Deviation 28.54 |
| AURN001 (5.0 × 10^5 Neltependocel + Y-27632 100 µM) | Change From Baseline in BCVA at All Other Timepoints | Month 12 | -1.6 change in ETDRS letters | Standard Deviation 30.3 |
| AURN001 (1.0 × 10^6 Neltependocel + Y-27632 100 µM) | Change From Baseline in BCVA at All Other Timepoints | Month 12 | 8.8 change in ETDRS letters | Standard Deviation 21.46 |
| AURN001 (1.0 × 10^6 Neltependocel + Y-27632 100 µM) | Change From Baseline in BCVA at All Other Timepoints | Month 9 | 8.2 change in ETDRS letters | Standard Deviation 18.98 |
| AURN001 (1.0 × 10^6 Neltependocel + Y-27632 100 µM) | Change From Baseline in BCVA at All Other Timepoints | Month 3 | 0.2 change in ETDRS letters | Standard Deviation 21.73 |
| AURN001 (1.0 × 10^6 Neltependocel + Y-27632 100 µM) | Change From Baseline in BCVA at All Other Timepoints | Month 2 | -12.1 change in ETDRS letters | Standard Deviation 28.37 |
| AURN001 (1.0 × 10^6 Neltependocel + Y-27632 100 µM) | Change From Baseline in BCVA at All Other Timepoints | Week 4 | -16.9 change in ETDRS letters | Standard Deviation 27.14 |
| AURN001 (1.0 × 10^6 Neltependocel + Y-27632 100 µM) | Change From Baseline in BCVA at All Other Timepoints | Month 6 | 6.8 change in ETDRS letters | Standard Deviation 18.67 |
| AURN001 (1.0 × 10^6 Neltependocel + Y-27632 100 µM) | Change From Baseline in BCVA at All Other Timepoints | Month 4.5 | 5.4 change in ETDRS letters | Standard Deviation 19.9 |
Secondary
Change From Baseline in BCVA at Month 6
Best-corrected visual acuity was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) method, the standard for vision testing. Standardized Sloan letter charts with five letters per line, decreasing by 0.1 logarithm of the minimum angle of resolution (LogMAR) per line, were used at 4 meters (or 1 meter if ≤19 letters were read, with +0.75 spherical power added). Each correct letter equaled one point (0.02 LogMAR), with 85 letters (0.0 LogMAR) corresponding to 20/20 Snellen, 70 letters (+0.3) to 20/40, and 35 letters (+1.0) to 20/200. A gain of ≥15 letters (0.3 LogMAR, 3 lines) was clinically meaningful. Data from the study eye only were included in the analysis. Participants read letters aloud, guessing encouraged, and all responses recorded for accuracy. Baseline was defined as the last measurement prior to the study drug injection on Day 1. Change from baseline values was calculated as follow-up visit minus baseline visit.
Time frame: Baseline (Day 1) and at Month 6
Population: Full Analysis Set.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Y-27632 100 µM | Change From Baseline in BCVA at Month 6 | -25.5 change in ETDRS letters | Standard Error 6.06 |
| Neltependocel (1.0 × 10^6) | Change From Baseline in BCVA at Month 6 | -5.1 change in ETDRS letters | Standard Error 6.41 |
| AURN001 (2.5 × 10^5 Neltependocel + Y-27632 100 µM) | Change From Baseline in BCVA at Month 6 | -15.7 change in ETDRS letters | Standard Error 6.24 |
| AURN001 (5.0 × 10^5 Neltependocel + Y-27632 100 µM) | Change From Baseline in BCVA at Month 6 | -3.0 change in ETDRS letters | Standard Error 6.25 |
| AURN001 (1.0 × 10^6 Neltependocel + Y-27632 100 µM) | Change From Baseline in BCVA at Month 6 | 10.4 change in ETDRS letters | Standard Error 6.17 |
p-value: 0.023295% CI: [2.9, 38]ANCOVA
p-value: 0.2695% CI: [-7.4, 27.1]ANCOVA
p-value: 0.011595% CI: [5.2, 39.9]ANCOVA
p-value: <0.000195% CI: [18.5, 53.4]ANCOVA
p-value: 0.240395% CI: [-28.4, 7.2]ANCOVA
p-value: 0.813895% CI: [-15.7, 19.9]ANCOVA
p-value: 0.083495% CI: [-2.1, 33.2]ANCOVA
Secondary
Change From Baseline in CCT at All Other Timepoints
Central corneal thickness was measured by pachymetry which is an essential anatomical marker for detecting the presence or absence of edema and serves as a supportive indicator of treatment efficacy. Baseline was defined as the last measurement prior to the study drug injection on Day 1. Change from baseline values was calculated as follow-up visit minus baseline visit.
Time frame: Baseline (Day 1) and at Weeks 1 and 4, Months 2, 3, 4.5, 6, 9, and 12
Population: Full Analysis Set. Only those participants with data available at specified time points has been presented.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Y-27632 100 µM | Change From Baseline in CCT at All Other Timepoints | Month 9 | 64.8 Microns | Standard Deviation 122.48 |
| Y-27632 100 µM | Change From Baseline in CCT at All Other Timepoints | Month 12 | 63.0 Microns | Standard Deviation 114.77 |
| Y-27632 100 µM | Change From Baseline in CCT at All Other Timepoints | Month 2 | 63.7 Microns | Standard Deviation 61.4 |
| Y-27632 100 µM | Change From Baseline in CCT at All Other Timepoints | Month 3 | 60.8 Microns | Standard Deviation 115.35 |
| Y-27632 100 µM | Change From Baseline in CCT at All Other Timepoints | Month 4.5 | 66.9 Microns | Standard Deviation 117.55 |
| Y-27632 100 µM | Change From Baseline in CCT at All Other Timepoints | Week 1 | 87.4 Microns | Standard Deviation 89.76 |
| Y-27632 100 µM | Change From Baseline in CCT at All Other Timepoints | Month 6 | 65.7 Microns | Standard Deviation 116.75 |
| Y-27632 100 µM | Change From Baseline in CCT at All Other Timepoints | Week 4 | 97.5 Microns | Standard Deviation 117.81 |
| Neltependocel (1.0 × 10^6) | Change From Baseline in CCT at All Other Timepoints | Month 6 | -5.7 Microns | Standard Deviation 112.03 |
| Neltependocel (1.0 × 10^6) | Change From Baseline in CCT at All Other Timepoints | Month 3 | -4.6 Microns | Standard Deviation 114.97 |
| Neltependocel (1.0 × 10^6) | Change From Baseline in CCT at All Other Timepoints | Week 1 | 116.9 Microns | Standard Deviation 134.59 |
| Neltependocel (1.0 × 10^6) | Change From Baseline in CCT at All Other Timepoints | Month 9 | -15.5 Microns | Standard Deviation 112.88 |
| Neltependocel (1.0 × 10^6) | Change From Baseline in CCT at All Other Timepoints | Month 2 | 64.4 Microns | Standard Deviation 100.38 |
| Neltependocel (1.0 × 10^6) | Change From Baseline in CCT at All Other Timepoints | Week 4 | 77.3 Microns | Standard Deviation 102.4 |
| Neltependocel (1.0 × 10^6) | Change From Baseline in CCT at All Other Timepoints | Month 4.5 | 6.3 Microns | Standard Deviation 113.65 |
| Neltependocel (1.0 × 10^6) | Change From Baseline in CCT at All Other Timepoints | Month 12 | -22.4 Microns | Standard Deviation 107.81 |
| AURN001 (2.5 × 10^5 Neltependocel + Y-27632 100 µM) | Change From Baseline in CCT at All Other Timepoints | Month 4.5 | -25.0 Microns | Standard Deviation 110.49 |
| AURN001 (2.5 × 10^5 Neltependocel + Y-27632 100 µM) | Change From Baseline in CCT at All Other Timepoints | Month 9 | -21.0 Microns | Standard Deviation 114.96 |
| AURN001 (2.5 × 10^5 Neltependocel + Y-27632 100 µM) | Change From Baseline in CCT at All Other Timepoints | Month 12 | -19.1 Microns | Standard Deviation 113.35 |
| AURN001 (2.5 × 10^5 Neltependocel + Y-27632 100 µM) | Change From Baseline in CCT at All Other Timepoints | Week 1 | 93.4 Microns | Standard Deviation 155.81 |
| AURN001 (2.5 × 10^5 Neltependocel + Y-27632 100 µM) | Change From Baseline in CCT at All Other Timepoints | Week 4 | 35.1 Microns | Standard Deviation 126.58 |
| AURN001 (2.5 × 10^5 Neltependocel + Y-27632 100 µM) | Change From Baseline in CCT at All Other Timepoints | Month 3 | -16.1 Microns | Standard Deviation 94.48 |
| AURN001 (2.5 × 10^5 Neltependocel + Y-27632 100 µM) | Change From Baseline in CCT at All Other Timepoints | Month 6 | -20.2 Microns | Standard Deviation 110.13 |
| AURN001 (2.5 × 10^5 Neltependocel + Y-27632 100 µM) | Change From Baseline in CCT at All Other Timepoints | Month 2 | 47.9 Microns | Standard Deviation 45.15 |
| AURN001 (5.0 × 10^5 Neltependocel + Y-27632 100 µM) | Change From Baseline in CCT at All Other Timepoints | Month 6 | -16.7 Microns | Standard Deviation 66.35 |
| AURN001 (5.0 × 10^5 Neltependocel + Y-27632 100 µM) | Change From Baseline in CCT at All Other Timepoints | Week 4 | 40.7 Microns | Standard Deviation 57.74 |
| AURN001 (5.0 × 10^5 Neltependocel + Y-27632 100 µM) | Change From Baseline in CCT at All Other Timepoints | Month 2 | 2.6 Microns | Standard Deviation 45.88 |
| AURN001 (5.0 × 10^5 Neltependocel + Y-27632 100 µM) | Change From Baseline in CCT at All Other Timepoints | Month 3 | -1.6 Microns | Standard Deviation 76.72 |
| AURN001 (5.0 × 10^5 Neltependocel + Y-27632 100 µM) | Change From Baseline in CCT at All Other Timepoints | Week 1 | 69.4 Microns | Standard Deviation 86.47 |
| AURN001 (5.0 × 10^5 Neltependocel + Y-27632 100 µM) | Change From Baseline in CCT at All Other Timepoints | Month 4.5 | -11.8 Microns | Standard Deviation 76.22 |
| AURN001 (5.0 × 10^5 Neltependocel + Y-27632 100 µM) | Change From Baseline in CCT at All Other Timepoints | Month 9 | -37.3 Microns | Standard Deviation 74.17 |
| AURN001 (5.0 × 10^5 Neltependocel + Y-27632 100 µM) | Change From Baseline in CCT at All Other Timepoints | Month 12 | -31.8 Microns | Standard Deviation 68.25 |
| AURN001 (1.0 × 10^6 Neltependocel + Y-27632 100 µM) | Change From Baseline in CCT at All Other Timepoints | Month 12 | -7.6 Microns | Standard Deviation 89.14 |
| AURN001 (1.0 × 10^6 Neltependocel + Y-27632 100 µM) | Change From Baseline in CCT at All Other Timepoints | Week 1 | 117.0 Microns | Standard Deviation 138.71 |
| AURN001 (1.0 × 10^6 Neltependocel + Y-27632 100 µM) | Change From Baseline in CCT at All Other Timepoints | Week 4 | 66.0 Microns | Standard Deviation 78.97 |
| AURN001 (1.0 × 10^6 Neltependocel + Y-27632 100 µM) | Change From Baseline in CCT at All Other Timepoints | Month 2 | 36.9 Microns | Standard Deviation 72.53 |
| AURN001 (1.0 × 10^6 Neltependocel + Y-27632 100 µM) | Change From Baseline in CCT at All Other Timepoints | Month 3 | 20.8 Microns | Standard Deviation 68.96 |
| AURN001 (1.0 × 10^6 Neltependocel + Y-27632 100 µM) | Change From Baseline in CCT at All Other Timepoints | Month 4.5 | 6.8 Microns | Standard Deviation 65.26 |
| AURN001 (1.0 × 10^6 Neltependocel + Y-27632 100 µM) | Change From Baseline in CCT at All Other Timepoints | Month 6 | 2.6 Microns | Standard Deviation 70.27 |
| AURN001 (1.0 × 10^6 Neltependocel + Y-27632 100 µM) | Change From Baseline in CCT at All Other Timepoints | Month 9 | -21.7 Microns | Standard Deviation 50.56 |
Secondary
Change From Baseline in Central Corneal Thickness (CCT) at Month 6
Central corneal thickness was measured by pachymetry which is an essential anatomical marker for detecting the presence or absence of edema and serves as a supportive indicator of treatment efficacy. Baseline was defined as the last measurement prior to the study drug injection on Day 1. Change from baseline values was calculated as follow-up visit minus baseline visit.
Time frame: Baseline (Day 1) and at Month 6
Population: Full Analysis Set.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Y-27632 100 µM | Change From Baseline in Central Corneal Thickness (CCT) at Month 6 | 67.5 Microns | Standard Error 20.52 |
| Neltependocel (1.0 × 10^6) | Change From Baseline in Central Corneal Thickness (CCT) at Month 6 | -7.6 Microns | Standard Error 22.17 |
| AURN001 (2.5 × 10^5 Neltependocel + Y-27632 100 µM) | Change From Baseline in Central Corneal Thickness (CCT) at Month 6 | -13.8 Microns | Standard Error 21.68 |
| AURN001 (5.0 × 10^5 Neltependocel + Y-27632 100 µM) | Change From Baseline in Central Corneal Thickness (CCT) at Month 6 | -5.6 Microns | Standard Error 21.91 |
| AURN001 (1.0 × 10^6 Neltependocel + Y-27632 100 µM) | Change From Baseline in Central Corneal Thickness (CCT) at Month 6 | -14.2 Microns | Standard Error 21.82 |
p-value: 0.014795% CI: [-135.2, -15.1]ANCOVA
p-value: 0.007795% CI: [-140.5, -22]ANCOVA
p-value: 0.016595% CI: [-132.6, -13.7]ANCOVA
p-value: 0.007995% CI: [-141.4, -22]ANCOVA
p-value: 0.844395% CI: [-67.8, 55.6]ANCOVA
p-value: 0.94995% CI: [-60.1, 64.1]ANCOVA
p-value: 0.832495% CI: [-68.1, 55]ANCOVA
Secondary
Percentage of Participants Achieving ≥10-letter Improvement in BCVA at All Timepoints - Observed Data
Best-corrected visual acuity was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) method, the standard for vision testing. Standardized Sloan letter charts with five letters per line, decreasing by 0.1 logarithm of the minimum angle of resolution (LogMAR) per line, were used at 4 meters (or 1 meter if ≤19 letters were read, with +0.75 spherical power added). Each correct letter equaled one point (0.02 LogMAR), with 85 letters (0.0 LogMAR) corresponding to 20/20 Snellen, 70 letters (+0.3) to 20/40, and 35 letters (+1.0) to 20/200. A gain of ≥15 letters (0.3 LogMAR, 3 lines) was clinically meaningful. Data from the study eye only were included in the analysis. Participants read letters aloud, guessing encouraged, and all responses recorded for accuracy. The data presented reflect only participants with non-missing BCVA at each corresponding visit.
Time frame: At Week 4 and at Months 2, 3, 4.5, 6, 9 and 12
Population: Full Analysis Set. Only those participants with data available at specified time points has been presented.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Y-27632 100 µM | Percentage of Participants Achieving ≥10-letter Improvement in BCVA at All Timepoints - Observed Data | Week 4 | 4.8 percentage of participants |
| Y-27632 100 µM | Percentage of Participants Achieving ≥10-letter Improvement in BCVA at All Timepoints - Observed Data | Month 3 | 6.7 percentage of participants |
| Y-27632 100 µM | Percentage of Participants Achieving ≥10-letter Improvement in BCVA at All Timepoints - Observed Data | Month 12 | 33.3 percentage of participants |
| Y-27632 100 µM | Percentage of Participants Achieving ≥10-letter Improvement in BCVA at All Timepoints - Observed Data | Month 2 | 0 percentage of participants |
| Y-27632 100 µM | Percentage of Participants Achieving ≥10-letter Improvement in BCVA at All Timepoints - Observed Data | Month 9 | 33.3 percentage of participants |
| Y-27632 100 µM | Percentage of Participants Achieving ≥10-letter Improvement in BCVA at All Timepoints - Observed Data | Month 6 | 50.0 percentage of participants |
| Y-27632 100 µM | Percentage of Participants Achieving ≥10-letter Improvement in BCVA at All Timepoints - Observed Data | Month 4.5 | 16.7 percentage of participants |
| Neltependocel (1.0 × 10^6) | Percentage of Participants Achieving ≥10-letter Improvement in BCVA at All Timepoints - Observed Data | Week 4 | 11.8 percentage of participants |
| Neltependocel (1.0 × 10^6) | Percentage of Participants Achieving ≥10-letter Improvement in BCVA at All Timepoints - Observed Data | Month 9 | 83.3 percentage of participants |
| Neltependocel (1.0 × 10^6) | Percentage of Participants Achieving ≥10-letter Improvement in BCVA at All Timepoints - Observed Data | Month 2 | 16.7 percentage of participants |
| Neltependocel (1.0 × 10^6) | Percentage of Participants Achieving ≥10-letter Improvement in BCVA at All Timepoints - Observed Data | Month 6 | 57.1 percentage of participants |
| Neltependocel (1.0 × 10^6) | Percentage of Participants Achieving ≥10-letter Improvement in BCVA at All Timepoints - Observed Data | Month 3 | 47.1 percentage of participants |
| Neltependocel (1.0 × 10^6) | Percentage of Participants Achieving ≥10-letter Improvement in BCVA at All Timepoints - Observed Data | Month 12 | 83.3 percentage of participants |
| Neltependocel (1.0 × 10^6) | Percentage of Participants Achieving ≥10-letter Improvement in BCVA at All Timepoints - Observed Data | Month 4.5 | 50.0 percentage of participants |
| AURN001 (2.5 × 10^5 Neltependocel + Y-27632 100 µM) | Percentage of Participants Achieving ≥10-letter Improvement in BCVA at All Timepoints - Observed Data | Month 12 | 42.9 percentage of participants |
| AURN001 (2.5 × 10^5 Neltependocel + Y-27632 100 µM) | Percentage of Participants Achieving ≥10-letter Improvement in BCVA at All Timepoints - Observed Data | Week 4 | 15.8 percentage of participants |
| AURN001 (2.5 × 10^5 Neltependocel + Y-27632 100 µM) | Percentage of Participants Achieving ≥10-letter Improvement in BCVA at All Timepoints - Observed Data | Month 9 | 37.5 percentage of participants |
| AURN001 (2.5 × 10^5 Neltependocel + Y-27632 100 µM) | Percentage of Participants Achieving ≥10-letter Improvement in BCVA at All Timepoints - Observed Data | Month 6 | 16.7 percentage of participants |
| AURN001 (2.5 × 10^5 Neltependocel + Y-27632 100 µM) | Percentage of Participants Achieving ≥10-letter Improvement in BCVA at All Timepoints - Observed Data | Month 2 | 14.3 percentage of participants |
| AURN001 (2.5 × 10^5 Neltependocel + Y-27632 100 µM) | Percentage of Participants Achieving ≥10-letter Improvement in BCVA at All Timepoints - Observed Data | Month 4.5 | 21.4 percentage of participants |
| AURN001 (2.5 × 10^5 Neltependocel + Y-27632 100 µM) | Percentage of Participants Achieving ≥10-letter Improvement in BCVA at All Timepoints - Observed Data | Month 3 | 11.8 percentage of participants |
| AURN001 (5.0 × 10^5 Neltependocel + Y-27632 100 µM) | Percentage of Participants Achieving ≥10-letter Improvement in BCVA at All Timepoints - Observed Data | Month 3 | 31.6 percentage of participants |
| AURN001 (5.0 × 10^5 Neltependocel + Y-27632 100 µM) | Percentage of Participants Achieving ≥10-letter Improvement in BCVA at All Timepoints - Observed Data | Month 12 | 66.7 percentage of participants |
| AURN001 (5.0 × 10^5 Neltependocel + Y-27632 100 µM) | Percentage of Participants Achieving ≥10-letter Improvement in BCVA at All Timepoints - Observed Data | Month 2 | 12.5 percentage of participants |
| AURN001 (5.0 × 10^5 Neltependocel + Y-27632 100 µM) | Percentage of Participants Achieving ≥10-letter Improvement in BCVA at All Timepoints - Observed Data | Month 9 | 53.8 percentage of participants |
| AURN001 (5.0 × 10^5 Neltependocel + Y-27632 100 µM) | Percentage of Participants Achieving ≥10-letter Improvement in BCVA at All Timepoints - Observed Data | Month 4.5 | 35.3 percentage of participants |
| AURN001 (5.0 × 10^5 Neltependocel + Y-27632 100 µM) | Percentage of Participants Achieving ≥10-letter Improvement in BCVA at All Timepoints - Observed Data | Month 6 | 43.8 percentage of participants |
| AURN001 (5.0 × 10^5 Neltependocel + Y-27632 100 µM) | Percentage of Participants Achieving ≥10-letter Improvement in BCVA at All Timepoints - Observed Data | Week 4 | 5.3 percentage of participants |
| AURN001 (1.0 × 10^6 Neltependocel + Y-27632 100 µM) | Percentage of Participants Achieving ≥10-letter Improvement in BCVA at All Timepoints - Observed Data | Month 12 | 82.4 percentage of participants |
| AURN001 (1.0 × 10^6 Neltependocel + Y-27632 100 µM) | Percentage of Participants Achieving ≥10-letter Improvement in BCVA at All Timepoints - Observed Data | Week 4 | 10.0 percentage of participants |
| AURN001 (1.0 × 10^6 Neltependocel + Y-27632 100 µM) | Percentage of Participants Achieving ≥10-letter Improvement in BCVA at All Timepoints - Observed Data | Month 2 | 40.0 percentage of participants |
| AURN001 (1.0 × 10^6 Neltependocel + Y-27632 100 µM) | Percentage of Participants Achieving ≥10-letter Improvement in BCVA at All Timepoints - Observed Data | Month 3 | 31.6 percentage of participants |
| AURN001 (1.0 × 10^6 Neltependocel + Y-27632 100 µM) | Percentage of Participants Achieving ≥10-letter Improvement in BCVA at All Timepoints - Observed Data | Month 6 | 57.9 percentage of participants |
| AURN001 (1.0 × 10^6 Neltependocel + Y-27632 100 µM) | Percentage of Participants Achieving ≥10-letter Improvement in BCVA at All Timepoints - Observed Data | Month 9 | 77.8 percentage of participants |
| AURN001 (1.0 × 10^6 Neltependocel + Y-27632 100 µM) | Percentage of Participants Achieving ≥10-letter Improvement in BCVA at All Timepoints - Observed Data | Month 4.5 | 52.6 percentage of participants |
Secondary
Percentage of Participants Achieving ≥15-letter Improvement in BCVA at All Timepoints - Observed Data
Best-corrected visual acuity was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) method, the standard for vision testing. Standardized Sloan letter charts with five letters per line, decreasing by 0.1 logarithm of the minimum angle of resolution (LogMAR) per line, were used at 4 meters (or 1 meter if ≤19 letters were read, with +0.75 spherical power added). Each correct letter equaled one point (0.02 LogMAR), with 85 letters (0.0 LogMAR) corresponding to 20/20 Snellen, 70 letters (+0.3) to 20/40, and 35 letters (+1.0) to 20/200. A gain of ≥15 letters (0.3 LogMAR, 3 lines) was clinically meaningful. Data from the study eye only were included in the analysis. Participants read letters aloud, guessing encouraged, and all responses recorded for accuracy. The data presented reflect only participants with non-missing BCVA at each corresponding visit.
Time frame: At Week 4 and at Months 2, 3, 4.5, 6, 9 and 12
Population: Full Analysis Set. Only those participants with data available at specified time points has been presented.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Y-27632 100 µM | Percentage of Participants Achieving ≥15-letter Improvement in BCVA at All Timepoints - Observed Data | Month 9 | 33.3 percentage of participants |
| Y-27632 100 µM | Percentage of Participants Achieving ≥15-letter Improvement in BCVA at All Timepoints - Observed Data | Month 4.5 | 0 percentage of participants |
| Y-27632 100 µM | Percentage of Participants Achieving ≥15-letter Improvement in BCVA at All Timepoints - Observed Data | Month 12 | 0 percentage of participants |
| Y-27632 100 µM | Percentage of Participants Achieving ≥15-letter Improvement in BCVA at All Timepoints - Observed Data | Month 6 | 50.0 percentage of participants |
| Y-27632 100 µM | Percentage of Participants Achieving ≥15-letter Improvement in BCVA at All Timepoints - Observed Data | Month 3 | 6.7 percentage of participants |
| Y-27632 100 µM | Percentage of Participants Achieving ≥15-letter Improvement in BCVA at All Timepoints - Observed Data | Month 2 | 0 percentage of participants |
| Y-27632 100 µM | Percentage of Participants Achieving ≥15-letter Improvement in BCVA at All Timepoints - Observed Data | Week 4 | 4.8 percentage of participants |
| Neltependocel (1.0 × 10^6) | Percentage of Participants Achieving ≥15-letter Improvement in BCVA at All Timepoints - Observed Data | Month 3 | 35.3 percentage of participants |
| Neltependocel (1.0 × 10^6) | Percentage of Participants Achieving ≥15-letter Improvement in BCVA at All Timepoints - Observed Data | Week 4 | 5.9 percentage of participants |
| Neltependocel (1.0 × 10^6) | Percentage of Participants Achieving ≥15-letter Improvement in BCVA at All Timepoints - Observed Data | Month 2 | 16.7 percentage of participants |
| Neltependocel (1.0 × 10^6) | Percentage of Participants Achieving ≥15-letter Improvement in BCVA at All Timepoints - Observed Data | Month 4.5 | 42.9 percentage of participants |
| Neltependocel (1.0 × 10^6) | Percentage of Participants Achieving ≥15-letter Improvement in BCVA at All Timepoints - Observed Data | Month 6 | 57.1 percentage of participants |
| Neltependocel (1.0 × 10^6) | Percentage of Participants Achieving ≥15-letter Improvement in BCVA at All Timepoints - Observed Data | Month 9 | 58.3 percentage of participants |
| Neltependocel (1.0 × 10^6) | Percentage of Participants Achieving ≥15-letter Improvement in BCVA at All Timepoints - Observed Data | Month 12 | 58.3 percentage of participants |
| AURN001 (2.5 × 10^5 Neltependocel + Y-27632 100 µM) | Percentage of Participants Achieving ≥15-letter Improvement in BCVA at All Timepoints - Observed Data | Month 12 | 28.6 percentage of participants |
| AURN001 (2.5 × 10^5 Neltependocel + Y-27632 100 µM) | Percentage of Participants Achieving ≥15-letter Improvement in BCVA at All Timepoints - Observed Data | Month 6 | 16.7 percentage of participants |
| AURN001 (2.5 × 10^5 Neltependocel + Y-27632 100 µM) | Percentage of Participants Achieving ≥15-letter Improvement in BCVA at All Timepoints - Observed Data | Month 2 | 0 percentage of participants |
| AURN001 (2.5 × 10^5 Neltependocel + Y-27632 100 µM) | Percentage of Participants Achieving ≥15-letter Improvement in BCVA at All Timepoints - Observed Data | Month 9 | 37.5 percentage of participants |
| AURN001 (2.5 × 10^5 Neltependocel + Y-27632 100 µM) | Percentage of Participants Achieving ≥15-letter Improvement in BCVA at All Timepoints - Observed Data | Month 3 | 11.8 percentage of participants |
| AURN001 (2.5 × 10^5 Neltependocel + Y-27632 100 µM) | Percentage of Participants Achieving ≥15-letter Improvement in BCVA at All Timepoints - Observed Data | Week 4 | 10.5 percentage of participants |
| AURN001 (2.5 × 10^5 Neltependocel + Y-27632 100 µM) | Percentage of Participants Achieving ≥15-letter Improvement in BCVA at All Timepoints - Observed Data | Month 4.5 | 14.3 percentage of participants |
| AURN001 (5.0 × 10^5 Neltependocel + Y-27632 100 µM) | Percentage of Participants Achieving ≥15-letter Improvement in BCVA at All Timepoints - Observed Data | Month 9 | 38.5 percentage of participants |
| AURN001 (5.0 × 10^5 Neltependocel + Y-27632 100 µM) | Percentage of Participants Achieving ≥15-letter Improvement in BCVA at All Timepoints - Observed Data | Month 4.5 | 29.4 percentage of participants |
| AURN001 (5.0 × 10^5 Neltependocel + Y-27632 100 µM) | Percentage of Participants Achieving ≥15-letter Improvement in BCVA at All Timepoints - Observed Data | Month 6 | 43.8 percentage of participants |
| AURN001 (5.0 × 10^5 Neltependocel + Y-27632 100 µM) | Percentage of Participants Achieving ≥15-letter Improvement in BCVA at All Timepoints - Observed Data | Week 4 | 5.3 percentage of participants |
| AURN001 (5.0 × 10^5 Neltependocel + Y-27632 100 µM) | Percentage of Participants Achieving ≥15-letter Improvement in BCVA at All Timepoints - Observed Data | Month 3 | 21.1 percentage of participants |
| AURN001 (5.0 × 10^5 Neltependocel + Y-27632 100 µM) | Percentage of Participants Achieving ≥15-letter Improvement in BCVA at All Timepoints - Observed Data | Month 12 | 66.7 percentage of participants |
| AURN001 (5.0 × 10^5 Neltependocel + Y-27632 100 µM) | Percentage of Participants Achieving ≥15-letter Improvement in BCVA at All Timepoints - Observed Data | Month 2 | 0 percentage of participants |
| AURN001 (1.0 × 10^6 Neltependocel + Y-27632 100 µM) | Percentage of Participants Achieving ≥15-letter Improvement in BCVA at All Timepoints - Observed Data | Month 6 | 52.6 percentage of participants |
| AURN001 (1.0 × 10^6 Neltependocel + Y-27632 100 µM) | Percentage of Participants Achieving ≥15-letter Improvement in BCVA at All Timepoints - Observed Data | Month 2 | 10.0 percentage of participants |
| AURN001 (1.0 × 10^6 Neltependocel + Y-27632 100 µM) | Percentage of Participants Achieving ≥15-letter Improvement in BCVA at All Timepoints - Observed Data | Month 4.5 | 36.8 percentage of participants |
| AURN001 (1.0 × 10^6 Neltependocel + Y-27632 100 µM) | Percentage of Participants Achieving ≥15-letter Improvement in BCVA at All Timepoints - Observed Data | Month 3 | 26.3 percentage of participants |
| AURN001 (1.0 × 10^6 Neltependocel + Y-27632 100 µM) | Percentage of Participants Achieving ≥15-letter Improvement in BCVA at All Timepoints - Observed Data | Month 9 | 50.0 percentage of participants |
| AURN001 (1.0 × 10^6 Neltependocel + Y-27632 100 µM) | Percentage of Participants Achieving ≥15-letter Improvement in BCVA at All Timepoints - Observed Data | Month 12 | 76.5 percentage of participants |
| AURN001 (1.0 × 10^6 Neltependocel + Y-27632 100 µM) | Percentage of Participants Achieving ≥15-letter Improvement in BCVA at All Timepoints - Observed Data | Week 4 | 10.0 percentage of participants |