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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 developed by Novartis AG for chronic ocular pain and for postoperative ocular pain following photorefractive keratectomy (PRK) surgery. It is a TRPV1 inhibitor and is in Phase 2 clinical development. It is not approved for any indication.
SAF312 is being studied for two eye pain indications: chronic ocular pain, including post-operative corneal induced chronic pain, and postoperative ocular pain after PRK surgery. Both uses remain investigational, as SAF312 is in Phase 2 testing and has not received regulatory approval.
SAF312 targets TRPV1, a receptor involved in pain signaling, and acts as a TRPV1 inhibitor. By inhibiting this target, the eye drop formulation is designed to reduce ocular pain. This mechanism underlies its study in chronic ocular pain and post-PRK postoperative pain.
SAF312 is developed by Novartis AG, which trades under the ticker NVS. Novartis is the sponsor of the clinical program evaluating the drug as an eye drop for chronic ocular pain and postoperative ocular pain after PRK surgery.
SAF312 is in Phase 2 clinical development. It is an investigational therapy and is not FDA approved. The completed Phase 2 trials evaluated the eye drop in chronic ocular pain and in postoperative ocular pain following PRK surgery.
SAF312 has been studied in two completed Phase 2 trials. NCT04630158 evaluated SAF312 eye drops in 153 subjects with post-operative corneal induced chronic pain across the United States, Japan, and United Kingdom. NCT02961062 evaluated SAF312 eye drops for eye pain after PRK surgery in 40 subjects in the United States.