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Also known as pazopanib eye drops, pazopanib eye
Pazopanib eye and Allergen Refresh Plus eye · 3 trials · 2 indications
BCVA was measured in the study eye using the ETDRS grading charts starting at a test distance of 4 meters. The ETDRS grading chart was of at least 24 to 78 letters. 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. There were seven cut off points in change from baseline visual acuity on ETDRS grading chart which are, 15 to 29, 10 to 14, 5 to 9, -4 to 4, -5 to -9, -10 to -14 and -15 to -29 letters. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. If either the baseline or post-randomization value was missing, the change from baseline was set to missing as well. Day 1 values are considered as Baseline in this study.
| Arm | Type | Description |
|---|---|---|
| investigational arm 1 | EXPERIMENTAL | 5 mg/mL pazopanib eye drops TID with allowance for as-needed ranibizumab injection |
| investigational arm 2 | EXPERIMENTAL | 5 mg/mL pazopanib eye drops QID with allowance for as-needed ranibizumab injection |
| investigational arm 3 | EXPERIMENTAL | 10 mg/mL pazopanib eye drops BID with allowance for as-needed ranibizumab injection |
| investigational arm 4 | EXPERIMENTAL | 10 mg/mL pazopanib eye drops TID with allowance for as-needed ranibizumab injection |
| investigational arm 5 | EXPERIMENTAL | 10 mg/mL pazopanib eye drops QID with allowance for as-needed ranibizumab injection |
| placebo control arm | PLACEBO_COMPARATOR | Placebo eye drops QID with allowance for as-needed ranibizumab injection |
| active open-label control arm | ACTIVE_COMPARATOR | Ranibizumab intravitreal injection every 4 weeks |
| Treatment A receivers | EXPERIMENTAL | Subjects received pazopanib, single dose as 2 x 40 microliter drops of 5 mg/mL solution in Period 1 |
| Treatment B receivers | EXPERIMENTAL | Subjects received ketoconazole, daily 400 mg oral dose on Days 1 to 8; pazopanib, single dose as 2 x 40 microliter drops of 5 mg/mL solution on Day 5 in Period 2 |
| Name | Type | Description |
|---|---|---|
| pazopanib eye drops | DRUG | A tyrosine kinase inhibitor of multiple receptors including vascular endothelial growth factor receptors and platelet-derived growth factor receptors. |
| placebo | DRUG | placebo eye drops |
| ranibizumab intravitreal injection | BIOLOGICAL | Humanized recombinant monoclonal antibody fragment targeted against human vascular endothelial growth factor A |
| Ketoconozole tablets | DRUG | Ketoconozole will be administered as tablets via oral route. Ketoconozole tablets will be present as white, rounded, scored tablets |
| Pazopanib eye drops and Allergen Refresh Plus eye drops | DRUG | - |
Inclusion Criteria: * Men and women aged ≥50 years. * Active subfoveal choroidal neovascularization (CNV) lesion secondary to AMD in study eye: Total lesion area ≤12 disc areas with CNV ≥50% total lesion area. * Anti-Vascular endothelial growth factor (VEGF) intravitreal injection experienced and i...
| 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 |
Pazopanib eye drops are being studied for the treatment of macular degeneration, including neovascular age-related macular degeneration. The investigational eye drop formulation is designed for topical ocular administration in ophthalmology. It is not approved for this use and remains in clinical development.
Pazopanib eye drops target FGFR1, FGFR3, CSF1R, PDGFRB, PDGFRA, and KIT. It is a small molecule inhibitor of these receptor tyrosine kinases. By inhibiting these targets, the eye drop formulation is intended to affect pathways relevant to macular degeneration.
Pazopanib eye drops are being developed by GSK plc, which trades under the ticker GSK. The company is responsible for the clinical development of this investigational ophthalmology asset.
Pazopanib eye drops are in Phase 2 clinical development for macular degeneration. The program includes a completed Phase 2 dose-ranging study and two completed Phase 1 studies. The drug is investigational and has not been approved for any indication.
Pazopanib eye drops have been evaluated in three completed trials: NCT01134055, a Phase 2 dose-ranging study in neovascular age-related macular degeneration; NCT00659555, a Phase 1 pharmacokinetic study; and NCT00463320, a Phase 1 safety and pharmacokinetic study. All three trials are completed.