Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as AGN-150998
Abicipar pegol · 9 trials · 3 indications
Stable vision was defined as vision loss of fewer than 15 letters in Best-corrected Visual Acuity (BCVA) from baseline. BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The percentage of participants with a BCVA loss of fewer than 15 letters are reported. Study eye was defined as the eye that meets the entry criteria. If both the eyes met all of the entry criteria, the eye with worse BCVA at baseline (Day 1) was selected. If BCVA values for both eyes were identical then participant had to select the non-dominant eye, or else right eye was selected as study eye.
Stable vision was defined as a loss of fewer than 15 letters in Best Corrected Visual Acuity (BCVA) compared to baseline. BCVA was measured using an eye chart and is reported as the number of letters read correctly using the Early Treatment of Diabetic Retinopathy Study (ETDRS) Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The study eye was defined as the eye that meets the entry criteria. If both eyes met the entry criteria, the eye with the worse BCVA at baseline (Day 1) was selected as the study eye. If both eyes had same BCVA values at baseline (Day 1), then the participant had to select their non-dominant eye for treatment, or else the right eye was selected as the study eye.
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase (positive number change from baseline) in the number of letters read correctly means that vision has improved and a decrease (negative number change from baseline) in the number of letters read correctly means that vision has worsened.
BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.
Stage 1 evaluated the safety of a single intravitreal injection of AGN-150998 with doses ranging from 1.0 to 4.2 mg.
CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from Baseline indicated improvement.
Recurrence of Active Disease was based on Best Corrected Visual Acuity (BCVA), Central Retinal Thickness (CRT) values as evaluated by the Central Reading Center (CRC) and the investigator assessments of haemorrhage.
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.
| Arm | Type | Description |
|---|---|---|
| Abicipar Pegol 2 mg (2Q8) | EXPERIMENTAL | Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, and Week 8, followed by injections every 8 weeks through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered. |
| Abicipar Pegol 2 mg (2Q12) | EXPERIMENTAL | Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, and Week 12, followed by injections every 12 weeks through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered. |
| Ranibizumab (rQ4) | ACTIVE_COMPARATOR | Ranibizumab (Lucentis®) was administered to the study eye by intravitreal injection every 4 weeks from Day 1 through Week 96. |
| Ranibizumab 0.5 mg (rQ4) | ACTIVE_COMPARATOR | Ranibizumab (Lucentis®) 0.5 mg was administered to the study eye by intravitreal injection every 4 weeks (rQ4) from Day 1 through Week 96. |
| Abicipar pegol 2 mg | EXPERIMENTAL | Abicipar pegol 2 mg administered to the study eye by intravitreal injection on Day 1 and Weeks 4, 8, 16, and 24. |
| abicipar pegol 1 mg | EXPERIMENTAL | Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16. |
| ranibizumab 0.5 mg | ACTIVE_COMPARATOR | Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16. |
| abicipar pegol 2 mg (group A) | EXPERIMENTAL | Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4, 8, and 20, followed by a sham procedure at weeks 12, 16, and 24. |
| abicipar pegol 2 mg (group B) | EXPERIMENTAL | Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4, 8, 16, and 24, followed by a sham procedure at weeks 12 and 20. |
| ranibizumab | ACTIVE_COMPARATOR | Ranibizumab (Lucentis®) administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 24. |
| Stage 1: AGN-150998 4.2 mg | EXPERIMENTAL | Stage 1: AGN-150998 4.2.mg given as a single intravitreal injection. |
| Stage 1: AGN-150998 3.0 mg | EXPERIMENTAL | Stage 1: AGN-150998 3.0 mg given as a single intravitreal injection. |
| Stage 1: AGN-150998 2.0 mg | EXPERIMENTAL | Stage 1: AGN-150998 2.0 mg given as a single intravitreal injection. |
| Stage 1: AGN-150998 1.0 mg | EXPERIMENTAL | Stage 1: AGN-150998 1.0 mg given as a single intravitreal injection. |
| Stage 2: AGN-150998 4.2 mg | EXPERIMENTAL | Stage 2: AGN-150998 4,2 mg (highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16. |
| Stage 2: AGN-150998 3.0 mg | EXPERIMENTAL | Stage 2: AGN-150998 3.0 mg (one dose below highest tolerated dose) from Stage 1 given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16. |
| Stage 2: ranibizumab 0.5 mg | ACTIVE_COMPARATOR | Stage 2: ranibizumab 0.5 mg given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16. |
| Stage 3: AGN-150998 2.0 mg | EXPERIMENTAL | Stage 3: AGN-150998 2.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16. |
| Stage 3: AGN-150998 1.0 mg | EXPERIMENTAL | Stage 3: AGN-150998 1.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16. |
| Stage 3: ranibizumab 0.5 mg | ACTIVE_COMPARATOR | Stage 3: ranibizumab 0.5 mg given as intravitreal injections every 4 weeks for 16 weeks. |
| Abicipar pegol | EXPERIMENTAL | Abicipar pegol 2 mg administered to the study eye by intravitreal injection |
| Abicipar Pegol_Repeat Dose | EXPERIMENTAL | Treatment Group 1: Abicipar pegol 2 mg administered to the study eye by intravitreal injection, 3 injections 4 weeks apart. \[Day 1, Weeks 4 and 8\] |
| Abicipar Pegol_Single Dose | EXPERIMENTAL | Treatment Group 2: Abicipar pegol 2 mg administered to the study eye by intravitreal injection on Day 1. |
| Name | Type | Description |
|---|---|---|
| Abicipar Pegol | DRUG | Abicipar pegol intravitreal injection. |
| Ranibizumab | DRUG | Ranibizumab intravitreal injection. |
| Sham Procedure | OTHER | Sham injection. |
| AGN-150998 | DRUG | AGN-150998 Intravitreal injection. |
| Sham Injection | OTHER | Stage 3: Sham injection at Weeks 12 and 16. |
Inclusion Criteria: * Diagnosis of age-related macular degeneration in at least 1 eye * Best corrected visual acuity of 20/40 to 20/320 in the study eye * Best corrected visual acuity of 20/200 or better in the non-study eye Exclusion Criteria: * History of vitrectomy, macular surgery, or glaucom...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AbbVie, Inc. | ABBV | 7 | PHASE3 | Surabgene Lomparvovec, RGX-314, ABBV-6628 |
| Ocular Therapeutix Inc | OCUL | 3 | PHASE3 | OTX-TKI |
| 4D Molecular Therapeutics, Inc. | FDMT | 3 | PHASE3 | 4D-150 |
| Regeneron Pharmaceuticals, Inc. | REGN | 2 | PHASE3 | Aflibercept, Pozelimab, Cemdisiran |
| Novartis AG Sponsored ADR | NVS | 5 | PHASE2 | Iptacopan, GT005, FWY003 |
| EyePoint, Inc. | EYPT | 2 | PHASE3 | EYP-1901 |
| Kodiak Sciences, Inc. | KOD | 1 | PHASE3 | Tarcocimab tedromer, Tabirafusp tedromer |
| Hoffmann-La Roche | RHHBY | 10 | PHASE3 | Ranibizumab, Susvimo, RO7965032, OpRegen, Faricimab |
| Outlook Therapeutics, Inc. | OTLK | 1 | PHASE3 | ONS-5010 |
| Adverum Biotechnologies, Inc. | ADVM | 4 | PHASE3 | Ixo-vec, ADVM-022 |
| Apellis Pharmaceuticals, Inc. | APLS | 1 | PHASE2 | APL-3007 |
| Amgen Inc. | AMGN | 1 | PHASE3 | ABP 938, Aflibercept |
| Johnson & Johnson | JNJ | 1 | PHASE2 | JNJ-81201887 |
| Ocugen Inc | OCGN | 1 | PHASE3 | OCU410 |
| Alcon AG | ALC | 1 | PHASE1 | AR-14034 |
| Sanofi SA Sponsored ADR | SNY | 1 | PHASE1 | SAR402663 |
| Arrowhead Pharmaceuticals, Inc. | ARWR | 1 | PHASE1 | ARO-033 |
| Bayer | BAYRY | 2 | - | Aflibercept |
Abicipar pegol is an investigational ophthalmic drug developed by AbbVie Inc. (ticker ABBV) for retinal conditions. It is being studied for macular degeneration and macular edema and is administered as an intravitreal injection into the eye. It remains in clinical development and has not been approved by the FDA.
Abicipar pegol is being studied for the treatment of neovascular age-related macular degeneration, a form of macular degeneration marked by abnormal blood vessel growth in the retina. Clinical trials have also enrolled patients with macular edema. It is an investigational therapy and is not approved for commercial use.
Abicipar pegol targets VEGFA, vascular endothelial growth factor A. It acts as an inhibitor of this target, which is a protein that drives the abnormal blood vessel formation and leakage seen in neovascular retinal diseases. By inhibiting VEGFA, the drug aims to reduce the vascular changes associated with macular degeneration.
Abicipar pegol is developed by AbbVie Inc., which trades under the ticker ABBV. AbbVie is the company responsible for the clinical development program for this investigational ophthalmology asset.
Abicipar pegol has reached Phase 3 clinical development. Its clinical program includes Phase 1, Phase 2, and Phase 3 studies, all of which are completed. The drug is investigational and has not been approved by the FDA for any indication.
Abicipar pegol has been evaluated in completed trials including NCT02462928, a Phase 3 study in neovascular age-related macular degeneration with 939 participants, NCT03539549, a Phase 2 study with 124 participants, and the Phase 1 studies NCT03335852 and NCT02859766. All seven trials in the program are completed.