Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SAF312 · 2 trials · 2 indications
The pain severity Visual Analogue Scale (VAS) was completed by the subject using an electronic diary. A vertical mark was placed on the horizontal scoring line (anchored with 'No Pain' on the left and 'Very Severe' pain on the right) to score the severity of ocular pain over the past 24 hours, with a range from 0 (min) to 100 (max). Higher scores indicate higher pain severity. A negative change from baseline is a positive outcome.
VAS pain severity scale pre-dose, 6 hours post-operatively. The Visual Analog Scale (VAS) is a commonly used measurement of pain, discomfort, that goes from 0 meaning no pain to 100 meaning worst imaginable pain
VAS pain severity scale from the first post-operative assessment to pre-dose 12 hours post-operative assesment The Visual Analog Scale (VAS) is a commonly used measurement of pain, discomfort, that goes from 0 meaning no pain to 100 meaning worst imaginable pain
| Arm | Type | Description |
|---|---|---|
| SAF312 Placebo | PLACEBO_COMPARATOR | Randomized to a 1:1:1 topical eye drops, twice daily |
| SAF312 5 mg/mL | EXPERIMENTAL | Randomized to a 1:1:1 topical eye drops, twice daily |
| SAF312 15 mg/mL | EXPERIMENTAL | Randomized to a 1:1:1 topical eye drops, twice daily |
| Treatment Sequence 1 | EXPERIMENTAL | - |
| Treatment Sequence 2 | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| SAF312 Placebo | OTHER | Topical ocular, suspension eye drops |
| SAF312 | DRUG | Topical ocular, suspension eye drops |
| Placebo | DRUG | - |
Key Inclusion Criteria: * Subjects who have undergone refractive surgery (i.e., PRK, LASIK, LASEK, RK, or SMILE) in both eyes or cataract surgery in both eyes, with or without refractive enhancement in one or both eyes, ≥4 months prior to Screening Visit and experiencing persistent ocular surface p...
SAF312 is an investigational small molecule eye drop being studied for chronic ocular pain and postoperative ocular pain after photorefractive keratectomy (PRK) surgery. It is in Phase 2 clinical development and is not approved by the FDA.
SAF312 is being developed by Novartis AG, which trades on the New York Stock Exchange under the ticker NVS. The company is evaluating the drug as an eye drop for ocular pain conditions.
SAF312 is in Phase 2 clinical development. Two Phase 2 trials have been completed, one in chronic ocular pain and one in postoperative ocular pain after PRK surgery. The drug remains investigational and is not FDA approved.
SAF312 has been studied in two completed Phase 2 trials. NCT02961062 enrolled 40 participants with postoperative ocular pain after PRK surgery in the United States. NCT04630158 enrolled 153 participants with chronic ocular pain across the United States, Japan, and the United Kingdom.
No alternative names for SAF312 have been disclosed. It is referred to solely as SAF312 in clinical trial records and by its developer, Novartis.