Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as AR-14034 SR implant lower dose, AR-14034 lower dose
AR-14034 · 1 trial · 1 indication
Visual acuity will be measured after manifest refraction using Early Treatment of Diabetic Retinopathy Study (ETDRS) letter charts in a 4-meter lane under standard illumination. Best corrected visual acuity (BCVA) will be recorded as the number of letters read correctly. The difference between the average across Weeks 44 and 48, and the baseline visit will be reported. One eye (study eye) will contribute to the analysis.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 (Stage 1) | EXPERIMENTAL | One intravitreal (IVT) injection of aflibercept 2 mg at Week -1 and one IVT insertion of AR-14034 SR lower dose at Baseline. Up to one retreatment with AR-14034 SR will be administered between Weeks 4 and 36 according to protocol-specified disease activity criteria. |
| Cohort 2 (Stage 1) | EXPERIMENTAL | One IVT injection of aflibercept 2 mg at Week -1 and one IVT insertion of AR-14034 SR higher dose at Baseline. Up to one retreatment with AR-14034 SR will be administered between Weeks 4 and 36 according to protocol-specified disease activity criteria. |
| AR-14034 SR one injection (Stage 2) | EXPERIMENTAL | One IVT injection of aflibercept 2 mg at Baseline, Week 4, and Week 8, with one IVT insertion of AR-14034 SR at Week 2. Sham procedures will be performed between Baseline and Week 52 when other arms are receiving scheduled treatment injections. |
| AR-14034 SR two injections (Stage 2) | EXPERIMENTAL | One IVT injection of aflibercept 2 mg at Baseline, Week 4, and Week 8, with IVT insertions of AR-14034 SR at Week 2 and Week 6. Sham procedures will be performed between Baseline and Week 52 when other arms are receiving scheduled treatment injections. |
| Aflibercept (Stage 2) | ACTIVE_COMPARATOR | One IVT injection of aflibercept 2 mg at Baseline, Week 4, Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48. Sham procedures will be performed between Baseline and Week 52 when other arms are receiving scheduled treatment injections. |
| Name | Type | Description |
|---|---|---|
| AR-14034 SR implant lower dose | DRUG | AR-14034 SR administered as an intravitreal implant |
| AR-14034 SR implant higher dose | DRUG | AR-14034 SR administered as an intravitreal implant |
| AR-14034 SR implant | DRUG | AR-14034 SR administered as an intravitreal implant |
| Aflibercept Injection | DRUG | Aflibercept administered as a 2 milligram (mg) intravitreal injection |
| Sham procedure | DRUG | Needleless syringe used to simulate an intravitreal injection |
Key Inclusion Criteria \[Stage 1 and Stage 2\]: * Presence of an active choroidal neovascularization (CNV) lesion secondary to age-related macular degeneration (AMD); * Best corrected visual acuity (BCVA) between 80 and 35 letters (20/25 to 20/200 Snellen equivalent) in the study eye; * BCVA greate...
AR-14034 is an investigational small molecule developed by Alcon Inc. (ticker ALC) for neovascular age-related macular degeneration, or nAMD. It is being studied as a sustained-release implant, including a lower-dose formulation. AR-14034 remains in clinical development and has not been approved by the FDA.
AR-14034 is being developed for the treatment of neovascular age-related macular degeneration, commonly called nAMD, a form of macular degeneration driven by abnormal blood vessel growth in the eye. The investigational therapy is delivered as a sustained-release implant and is being evaluated in adults age 50 and older.
AR-14034 is developed by Alcon Inc., which trades under the ticker ALC. Alcon is the sponsor of the clinical program evaluating the small molecule implant in neovascular age-related macular degeneration. The asset is also referred to as the AR-14034 SR implant lower dose or AR-14034 lower dose.
AR-14034 is in Phase 1 clinical development. It is an investigational therapy and has not been approved by the FDA for any indication. The Phase 1 program is evaluating the small molecule implant in participants with neovascular age-related macular degeneration.
AR-14034 is being studied in the Phase 1 trial NCT05769153, titled Study of AR-14034 in Participants With Neovascular Age-Related Macular Degeneration (nAMD). The trial is active but not recruiting, enrolled 139 participants in the United States, and uses a randomized, double-blind, active-controlled design.
Yes. AR-14034 SR implant lower dose and AR-14034 lower dose are alternative names for AR-14034, the small molecule sustained-release implant developed by Alcon Inc. for neovascular age-related macular degeneration. Searches using those alternative names refer to the same investigational asset.