Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as OMS302 Solution, OMS302 Irrigation Solution
OMS302 · 5 trials · 5 indications
Mean Area-under-the-Curve (AUC) Analysis of Change From Baseline in Pupil Diameter (mm/min) During Surgery Excluding Subjects with In-evaluable Videos.
Mean AUC Analysis of Postoperative pain as measured using the Alder Hey Triage Pain Score at 3, 6, 9, and 24 hours after surgery. The primary analysis of Alder Hey Triage Pain Score was similar to the primary analysis of the change in pupil diameter using AUC. The Alder Hey Triage Pain Score identifies five categories of observations: voice/cry, facial expression, posture, movement, and color. Each of these has a possible score of 0, 1, or 2, resulting in a total score ranging between 0 and 10. A total score of zero means the subject experienced no pain, as the 5 categories added up totals zero. A total score of 10 means the subject experienced a lot of pain and is the worst possible outcome, as the 5 categories added up totals 10. Parent responses in a diary with a score of 0, 1, or 2. 1. Cry or voice, 0=no compliant/cry, 1=Consolable, 2=Inconsolable 2. Facial Expression, 0=Normal, 1=Short grimace \<50% of time, 2=Long grimace \>50% of time 3. Posture, 0=Normal, 1=Touching/rub
Safety as assessed by the incidence of adverse events and serious adverse events up until the last visit at Day 90.
The co-primary analysis of the change in pupil diameter based on the mean area under the curve (AUC) pupil diameter change from baseline. First, the AUC of the pupil diameter from surgical baseline to wound closure was calculated using the trapezoidal rule. Second, the mean AUC was obtained by dividing the AUC by the total time of surgery. Third, the mean AUC of change from baseline was calculated by subtracting the baseline pupil diameter from the mean AUC.
The co-primary analysis of the ocular pain VAS (where 0 = no pain and 100 = worst possible pain) based on the mean area under the curve (AUC). The AUC of the ocular pain VAS during 12 hours postoperatively was calculated by the trapezoidal rule in which the hour 11 was used to represent the time-point 10-12 hour. The mean AUC was defined as the AUC divided by the number of hours with ocular pain VAS results during the first 12 hours postoperatively.
Change in pupil diameter over time from surgical baseline (immediately prior to surgical incision) to the end of the surgical procedure (wound closure) was summarized using descriptive statistics by treatment arm and time-point (every minute). The primary analysis of the change in pupil diameter was based on the mean area-under-the-curve (AUC) pupil diameter change from baseline. First, the AUC of the pupil diameter from surgical baseline to wound closure was calculated using the trapezoidal rule. Second, the mean AUC was obtained by dividing the AUC by the total time of surgery. Third, the mean AUC of change from baseline was calculated by subtracting the baseline pupil diameter from the mean AUC.
Pupil diameter from surgical baseline (immediately prior to surgical incision) to the end of the surgical procedure (wound closure) was summarized using descriptive statistics by treatment group and time point. Repeated measures analyses of variance were used to test for differences in the maintenance of mydriasis. The repeated measures model included change from baseline pupil diameter as the response variable and treatment (OMS302, ketorolac tromethamine, and vehicle), time point (as a categorical variable) and the stratification factor lens opacities classification system II (LOCS II) grade as predictor variables. A generalized estimating equation (GEE) approach with an AR(1) working-correlation structure was used.
For the primary analysis of this endpoint, only the results on the day of operation at 2, 4, 6, 8 and 10-12 hours were utilized. The VAS scores (where 0 = no pain and 100 = worst possible pain) were summarized by treatment group and time point. Repeated measures analyses of variance were used to test for differences in postoperative ocular pain. The repeated measures model included VAS pain score as the response variable and treatment (OMS302, phenylephrine hydrochloride (PE), and vehicle), time point (as a categorical variable) and the stratification factor LOCS II grade as predictor variables. A generalized estimating equation (GEE) approach with an AR(1) working correlation structure was used.
| Arm | Type | Description |
|---|---|---|
| OMS302 | EXPERIMENTAL | OMS302 diluted in balanced salt solution (BSS) and administered as irrigation solution |
| Phenylephrine HCl | ACTIVE_COMPARATOR | Phenylephrine diluted in balanced salt solution (BSS) and administered as irrigation solution |
| Placebo | PLACEBO_COMPARATOR | Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery. |
| OMS302 Solution | EXPERIMENTAL | OMS302 Solution |
| OMS302 Mydriatic Solution | EXPERIMENTAL | OMS302 Mydriatic Solution |
| OMS302 Anti-inflammatory Solution | EXPERIMENTAL | OMS302 Anti-inflammatory Solution |
| Balanced Salt Solution (BSS) Solution | PLACEBO_COMPARATOR | Balanced Salt Solution (BSS) Solution |
| 1 | EXPERIMENTAL | OMS302 Irrigation Solution |
| 2 | ACTIVE_COMPARATOR | OMS302-PE HCl Irrigation Solution |
| 3 | PLACEBO_COMPARATOR | Standard topical mydriatics and BSS Irrigation Solution |
| Name | Type | Description |
|---|---|---|
| OMS302 | DRUG | - |
| Phenylephrine HCl | DRUG | - |
| Placebo | DRUG | Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product is added to a 500 mL bottle of commercially available BSS through a syringe filter. This will achieve 4.0 mL of the drug product in a 500 mL bottle of BSS. |
| OMS302 Solution | DRUG | - |
| OMS302 Mydriatic Solution | DRUG | - |
| OMS302 Anti-inflammatory Solution | DRUG | - |
| Balanced Salt Solution (BSS) Solution | DRUG | - |
| OMS302-PE | DRUG | OMS302-PE HCI Irrigation Solution |
| Vehicle | DRUG | Standard topical mydriatics and Balanced Salt Solution Irrigation Solution |
Inclusion Criteria: 1. Are 0 through three years of age at the time of surgery. 2. Are to undergo unilateral primary cataract extraction with or without lens replacement. 3. Have informed consent and Health Insurance Portability and Accountability Act (HIPAA) Authorization provided by a parent or l...
OMS302 is an investigational ophthalmology product being developed for use during cataract extraction and intraocular lens replacement procedures. It is studied in adult patients undergoing these eye surgeries, as well as in children undergoing unilateral cataract extraction with or without lens replacement. It is not approved and remains in clinical development.
OMS302 is developed by Omeros Corporation, which trades on the Nasdaq under the ticker OMER. Omeros is the sponsor of the clinical trials evaluating OMS302 in cataract and intraocular lens replacement procedures.
OMS302 is in Phase 2 development. Clinical trials for OMS302 have been completed, including Phase 2 and Phase 3 studies, and no trials are currently active. It is an investigational product and has not been approved by the FDA.
OMS302 has been studied in completed trials including NCT02132312 in children undergoing unilateral cataract extraction, NCT01579565 and NCT01454063 in adults undergoing intraocular lens replacement with phacoemulsification, and NCT01193127 in adults undergoing unilateral cataract extraction with lens replacement. These trials enrolled a total of 821 participants.
Yes, OMS302 Solution is another name for OMS302. Both refer to the same investigational ophthalmology product developed by Omeros Corporation for use in cataract extraction and intraocular lens replacement procedures.
OMS302 is being developed for use in cataract surgery, specifically for patients undergoing cataract extraction and intraocular lens replacement. It has been evaluated in randomized, double-blind, placebo-controlled trials in adults and in children undergoing unilateral cataract extraction with or without lens replacement.