Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as LHA510 Ophthalmic Suspension
LHA510 · 2 trials · 2 indications
For subjects who completed the Day 84 visit, retreatment need status was positive if LUCENTIS® retreatment (injection) was required before or at Day 84, including requiring retreatment at or before the Day 84 visit with the actual retreatment performed at a later visit.
A serious adverse event (SAE) was defined as any event which is fatal or life-threatening, which requires or prolongs hospitalization, which is significantly or permanently disabling or incapacitating, which constitutes a congenital anomaly or a birth defect, or which is medically significant, may jeopardize the subject and may require medical or surgical intervention to prevent one of the outcomes listed above.
A serious adverse event (SAE) was defined as any event which is fatal or life-threatening, which requires or prolongs hospitalization, which is significantly or permanently disabling or incapacitating, which constitutes a congenital anomaly or a birth defect, or which is medically significant, may jeopardize the subject and may require medical or surgical intervention to prevent one of the outcomes listed above.
An adverse event (AE) was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment.
An adverse event (AE) was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment.
| Arm | Type | Description |
|---|---|---|
| LHA510 | EXPERIMENTAL | LHA510 ophthalmic suspension administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy. |
| Vehicle | PLACEBO_COMPARATOR | LHA510 vehicle administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy. |
| LHA510 Part 1 | EXPERIMENTAL | LHA510 Ophthalmic Suspension in 1 of 4 concentrations, 1 drop instilled in the study eye as a single dose during Part 1 |
| LHA510 Vehicle Part 1 | PLACEBO_COMPARATOR | Inactive ingredients, 1 drop instilled in the study eye as a single dose during Part 1 |
| LHA510 Part 2 | EXPERIMENTAL | LHA510 Ophthalmic Suspension in 1 of 4 concentrations, 1 drop instilled in the study eye once, twice, or three times daily for 7 days during Part 2 |
| LHA510 Vehicle Part 2 | PLACEBO_COMPARATOR | Inactive ingredients, 1 drop instilled in the study eye once, twice, or 3 times daily for 7 days during Part 2 |
| Name | Type | Description |
|---|---|---|
| LHA510 ophthalmic suspension | DRUG | - |
| LHA510 vehicle | DRUG | Inactive ingredients used as a placebo comparator |
| Ranibizumab ophthalmic solution | DRUG | For intravitreal (IVT) injection |
Inclusion Criteria: * Sign written informed consent form; * Wet AMD; * IVT anti-VEGF therapy for at least 6 months and a maximum of 7 years since the 3rd loading dose; * BCVA 50 letters (approximate Snellen equivalent 20/100) or better in the study eye; * Demonstrate ability to administer eye drops...
LHA510 is an investigational small molecule developed by Alcon Inc. (ticker ALC) as an ophthalmic suspension. It is being studied in ophthalmology for age-related macular degeneration, including the exudative (wet) form. It is not approved and remains in clinical development.
LHA510 is being studied for age-related macular degeneration, specifically exudative age-related macular degeneration, also called wet AMD. One trial evaluated it as a maintenance therapy for patients with wet AMD. It is investigational and has not been approved for any use.
LHA510 is developed by Alcon Inc., which trades under the ticker ALC. Alcon is the sponsor of the clinical program studying the drug in age-related macular degeneration.
LHA510 is in Phase 1 development. A first-in-human Phase 1 study was completed, and a separate proof-of-concept study in wet age-related macular degeneration is listed as Phase 2. The drug is investigational and has not been approved by the FDA.
LHA510 has been studied in two completed trials. NCT02076919 was a first-in-human Phase 1 study in elderly subjects and patients with age-related macular degeneration. NCT02355028 was a Phase 2 proof-of-concept study of LHA510 as maintenance therapy in wet age-related macular degeneration, enrolling 136 patients in the United States.
Yes. LHA510 ophthalmic suspension is another name for LHA510, the investigational small molecule developed by Alcon Inc. for age-related macular degeneration. The ophthalmic suspension describes the formulation used in the clinical program.