Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LME636/mL · 1 trial · 1 indication
Response was defined as a two-step decrease or more from baseline in Anterior Chamber (AC) Cell Grade as per Standardization of Uveitis Nomenclature (SUN). Baseline was defined as the measurement taken before drug administration on Day 1. Subjects receiving rescue treatment on or before Day 15 were considered non-responders. Only one eye contributed to the analysis.
Visual Acuity (VA) with the subject's best spectacles or other visual corrective devices was measured using an Early Treatment of Diabetic Retinopathy Study (ETDRS) or Snellen visual acuity chart and reported in letters read correctly. An increase (gain) in letters read indicates improvement. Only one eye contributed to the analysis.
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry or Tonopen and reported in millimeters mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Only one eye contributed to the analysis.
Slit-lamp biomicroscopy (examination) was performed to evaluate the anterior segment of the eye, including lids/lashes, conjunctiva, cornea, anterior chamber (cells and flare), iris, and lens. Ocular signs were categorized as Aqueous Flare, Aqueous Inflammatory Cell Grade, Keratic Precipitates, Lens, Limbal Injection, Status of Lens, Peripheral Anterior Synechia, and Posterior Synechia. An increase indicates worsening. Only one eye contributed to the analysis.
The dilated fundus examination was performed to evaluate the health of the vitreous, optic disc, retinal vessels, macula, and retinal periphery. An increase indicates worsening. Only one eye contributed to the analysis.
| Arm | Type | Description |
|---|---|---|
| LME636 | EXPERIMENTAL | LME636 60 mg/mL ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 1 week (Week 3) and 1 week of masked Vehicle administration (Week 4) |
| Dexamethasone | ACTIVE_COMPARATOR | Dexamethasone 0.1% ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 2 weeks (Weeks 3 and 4) |
| Name | Type | Description |
|---|---|---|
| LME636 60 mg/mL ophthalmic solution | DRUG | - |
| Dexamethasone 0.1% ophthalmic solution | DRUG | - |
| LME636 Vehicle | DRUG | Inactive ingredients used for masking purposes |
Inclusion Criteria: * Provide written informed consent. * Diagnosis of non-infectious AAU in at least 1 eye. * Anterior chamber cell score of 2+ or 3+ as per Standardization of Uveitis Nomenclature (SUN) in at least one eye. * Able to communicate well with the Investigator, to understand and comply...
LME636 is an investigational monoclonal antibody being developed by Alcon Inc. for ophthalmology indications, specifically dry eye disease and acute anterior uveitis. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
LME636 is a monoclonal antibody, but its specific molecular target has not been disclosed in available information. The drug is being studied for its potential to treat dry eye disease and acute anterior uveitis, though the precise mechanism of action remains unspecified.
LME636 is being developed by Alcon Inc., a company traded under the ticker symbol ALC. The drug is an investigational monoclonal antibody in Phase 2 clinical trials for ophthalmology indications, including dry eye and acute anterior uveitis.
LME636 is in Phase 2 clinical development. It has completed two Phase 2 trials, one for severe dry eye disease and another for acute anterior uveitis. The drug remains investigational and has not received FDA approval.
LME636 has completed two Phase 2 clinical trials. NCT02365519 evaluated the drug in 514 subjects with severe dry eye disease, while NCT02482129 assessed its safety and efficacy in 45 patients with acute anterior uveitis. Both trials were randomized, double-blind, and placebo-controlled.
No alternative names for LME636 have been identified. The drug is known solely by its code name LME636 and is being developed by Alcon Inc. for ophthalmology indications.