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NOV03 · 3 trials · 2 indications
The National Eye Institute (NEI) scale relies on a chart that divides the cornea into five sections (central, superior, temporal, nasal, and inferior) and assigns a value from 0 (absent) to 3 (severe) to each section, based on the amount, size, and confluence of the punctate keratitis, for a maximum total score of 15 points (sum of scores for each section).
Study staff will ask participants to rate their severity of ocular dryness (both eyes simultaneously) by placing a vertical mark on a horizontal line to indicate the level of discomfort (0 corresponds to "no dryness" and 100% corresponds to "maximal dryness").
Corneal Fluorescein Staining (tCFS) is graded based on the NEI scale. The NEI scale divides the cornea in 5 subregions: central, inferior, superior, nasal, temporal. The score for each region ranges from 0-3; 0 corresponds to no staining, 3 corresponds to maximum staining. The total score is the sum of the 5 subregions ranging from 0-15.
Dryness Score is rated on a visual analogue scale (VAS) ranging from 0-100; 0 corresponds to no discomfort and 100 to maximum discomfort).
| Arm | Type | Description |
|---|---|---|
| NOV03 | EXPERIMENTAL | 100% perfluorohexyloctane 4 times daily (QID) |
| Saline solution | PLACEBO_COMPARATOR | 0.6% sodium chloride solution 4 times daily (QID) |
| NOV03 4 times daily (QID) | EXPERIMENTAL | 100% Perfluorohexyloctance solution 4 times daily (QID) |
| Placebo 4 times daily (QID) | PLACEBO_COMPARATOR | Saline solution (0.6% sodium chloride solution) 4 times daily (QID) |
| Name | Type | Description |
|---|---|---|
| NOV03 | DRUG | 100% perfluorohexyloctane |
| Saline Solution | DRUG | 0.6% sodium chloride solution |
| Placebo | DRUG | Saline solution (0.6% sodium chloride solution) |
Inclusion Criteria: 1. Was at least 18 years of age at the time of consent. 2. Provided written informed consent. 3. Had a subject-reported history of DED in both eyes for at least 6 months prior to Visit 0. 4. Had a TFBUT ≤5 seconds at Visit 0 and Visit 1. 5. Had an OSDI score ≥25 at Visit 0 and V...
Top 4 of 6 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Vanda Pharmaceuticals Inc. | VNDA | 1 | PHASE2 | VSJ-110 |
| AbbVie, Inc. | ABBV | 1 | PHASE1 | ABBV-319 |
| Oculis Holding AG | OCS | 1 | PHASE2 | licaminlimab |
| Bausch Health Companies Inc. | BHC | 1 | PHASE2 | BL1107 |
NOV03 is an investigational small molecule developed by Bausch + Lomb Corporation for dry eye disease. It has been studied in three completed Phase 3 clinical trials, including the Mojave, Kalahari, and Gobi studies, which together enrolled 1,475 participants. NOV03 is not yet approved and remains in clinical development.
NOV03 is being developed for the treatment of dry eye disease, including dry eye disease associated with meibomian gland dysfunction. Its Phase 3 program evaluated the drug in adults 18 years and older with these conditions. It is investigational and has not been approved for commercial use.
NOV03 is developed by Bausch + Lomb Corporation, which trades under the ticker BLCO. The company sponsored the Phase 3 clinical program for the drug, including the Mojave, Kalahari, and Gobi studies conducted in the United States.
NOV03 is in Phase 3 development. Three Phase 3 trials have been completed: the Mojave, Kalahari, and Gobi studies. All three are listed as completed, and no active trials are currently underway. The drug is investigational and has not been approved by the FDA.
NOV03 has been evaluated in three completed Phase 3 trials. The Mojave Study (NCT04567329) enrolled 620 participants, the Kalahari Study (NCT04140227) enrolled 256 participants, and the Gobi Study (NCT04139798) enrolled 599 participants. All were randomized, double-blind, placebo-controlled trials in dry eye disease conducted in the United States.
Yes, NOV03 is also known as perfluorohexyloctane. The Kalahari Study (NCT04140227) and Gobi Study (NCT04139798) refer to the drug by both names, confirming they are the same investigational small molecule being developed by Bausch + Lomb for dry eye disease.