Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AbbVie, Inc. | ABBV | 2 | PHASE3 | ABBV-444, REFRESH OPTIVE UD |
| Vanda Pharmaceuticals Inc. | VNDA | 1 | PHASE2 | VSJ-110 |
| Oculis Holding AG | OCS | 1 | PHASE2 | licaminlimab |
| Alcon AG | ALC | 1 | N/A | Undisclosed |
| Harrow, Inc. | HROW | 1 | - | Undisclosed |
NOV03 is an investigational small molecule being developed for the treatment of Dry Eye Disease (DED), including DED associated with Meibomian Gland Dysfunction. It is currently in Phase 3 clinical development and has not been approved by the FDA.
NOV03 is being developed by Bausch + Lomb Corporation, a company traded on the New York Stock Exchange under the ticker symbol BLCO. The drug is currently in Phase 3 clinical trials for Dry Eye Disease.
NOV03 is in Phase 3 clinical development for Dry Eye Disease. It is an investigational drug and has not received FDA approval. Three Phase 3 trials have been completed, studying the drug's efficacy and safety in patients with DED.
NOV03 has completed three Phase 3 trials: NCT04139798 (Gobi Study), NCT04140227 (Kalahari Study), and NCT04567329 (Mojave Study). These trials enrolled a total of 855 patients with Dry Eye Disease and were conducted in the United States.
NOV03 is a small molecule designed to treat Dry Eye Disease. Its mechanism of action is not disclosed in the available clinical trial information, but it is being studied for its ability to address both signs and symptoms of DED, particularly in patients with Meibomian Gland Dysfunction.