Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LME636 · 1 trial · 1 indication
Discomfort frequency and severity (each graded on a separate 100-units scale) were assessed daily using a visual analog scale (VAS) displayed on a handheld digital Pad (electronic patient-reported outcome (ePRO)). Frequency score was in response to the question 'how often your eyes felt uncomfortable during the past 24 hours' ranging from 'Rarely' to 'All the time.' Severity score was in response to the question 'how uncomfortable your eyes felt during the past 24 hours' ranging from 'Very mildly uncomfortable' to 'Very severely uncomfortable.' The Global Ocular Discomfort Score, ranging from 0 to 100, was calculated for any given day, as the square root of the product of the discomfort frequency score multiplied by the discomfort severity score. Improvement results in a reduction of the discomfort frequency or severity, or both, translating into a reduction of the resulting Global Ocular Discomfort score as compared to baseline. A negative change from baseline indicates improvement.
Visual Acuity (VA) with the subject's best spectacles or other visual corrective devices was measured using an ETDRS visual acuity chart at 3 meters (10 feet) and reported in letters read correctly. An increase (gain) in letters read indicates improvement. Both eyes contributed to the analysis.
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry or Tonopen and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Both eyes contributed to the analysis.
Ocular signs (cornea, lens, and iris/anterior chamber) were assessed by slit-lamp biomicroscopy. An increase indicates worsening. Only one eye contributed to the analysis.
The dilated fundus examination was performed to evaluate the health of the vitreous, retina, macula, choroid, and optic nerve. An increase indicates worsening. Only one eye contributed to the analysis.
| Arm | Type | Description |
|---|---|---|
| LME636 | EXPERIMENTAL | LME636 ophthalmic solution, 1 drop (approx. 40 µL; 2.4 mg) administered topically in each eye 3 times a day (TID) for 6 weeks |
| Vehicle | PLACEBO_COMPARATOR | LME636 Vehicle, 1 drop administered topically in each eye TID for 6 weeks |
| Name | Type | Description |
|---|---|---|
| LME636 ophthalmic solution | BIOLOGICAL | - |
| LME636 Vehicle | BIOLOGICAL | Inactive ingredients used as a placebo comparator |
Inclusion Criteria: * Must sign written informed consent. * Physician diagnosis of DED of at least 6 months prior to Visit 1. * Must use artificial tears, gels, lubricants or re-wetting drops on a regular basis. * Respond as "often" or "constantly" to the question "How often do your eyes feel uncom...
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.