Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 being developed for exudative age-related macular degeneration and age-related macular degeneration. It is being studied as a potential maintenance therapy for patients with wet age-related macular degeneration. The drug is in clinical development and is not approved by the FDA.
LHA510 is a small molecule designed to target pathways involved in age-related macular degeneration. Its exact molecular target has not been disclosed in available information. It is being investigated for its ability to treat exudative AMD, potentially as a maintenance therapy.
LHA510 is being developed by Alcon Inc., a company traded on the New York Stock Exchange under the ticker ALC. Alcon is conducting clinical trials to evaluate the safety and efficacy of LHA510 in patients with age-related macular degeneration.
LHA510 has completed Phase 1 and Phase 2 clinical trials. The Phase 1 trial was a first-in-human study, and the Phase 2 trial was a proof-of-concept study as a maintenance therapy for wet AMD. The drug is investigational and not yet approved.
LHA510 has been studied in two completed trials. NCT02076919 was a Phase 1 first-in-human study in elderly subjects and AMD patients. NCT02355028 was a Phase 2 proof-of-concept study as a maintenance therapy for wet AMD in the United States.
LHA510 is a distinct investigational small molecule developed by Alcon. It is not known to be the same as other marketed AMD treatments. Its mechanism and chemical structure are not publicly detailed, and it is being studied as a potential oral or topical therapy.