Approval Probability
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Also known as LME636 ophthalmic solution
LME636 · 2 trials · 2 indications
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.
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 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) |
| Vehicle | PLACEBO_COMPARATOR | LME636 Vehicle, 1 drop administered topically in each eye TID for 6 weeks |
| 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 |
| LME636 ophthalmic solution | BIOLOGICAL | - |
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 small molecule ophthalmic solution developed by Alcon Inc. (ticker ALC). It is being studied in Phase 2 clinical trials for two eye conditions: acute anterior uveitis and dry eye disease. LME636 is not yet approved and remains in clinical development.
LME636 is being evaluated for the treatment of acute anterior uveitis and for the relief of persistent ocular discomfort in patients with severe dry eye disease. Both are inflammatory or discomfort-related conditions of the eye. The drug is investigational and has not been approved for any use.
LME636 is developed by Alcon Inc., which trades under the ticker ALC. Alcon is an eye care company, and LME636 is part of its ophthalmology pipeline as an investigational ophthalmic solution in Phase 2 development.
LME636 is in Phase 2 development. Two Phase 2 trials have been completed, one in acute anterior uveitis and one in severe dry eye disease. The drug is investigational and has not been approved by the FDA for any indication.
LME636 has been studied in two completed Phase 2 trials. NCT02482129 was a proof of concept study evaluating safety and efficacy in acute anterior uveitis with 45 participants. NCT02365519 evaluated LME636 in 514 subjects with severe dry eye disease. Both trials are completed.
Yes. LME636 is also referred to as LME636 ophthalmic solution, LME636 60 mg/mL ophthalmic solution, and LME636/mL. These names describe the same investigational small molecule eye drop developed by Alcon Inc. for acute anterior uveitis and dry eye disease.