Bausch+Lomb Results Presentation Deck
NOV031: Submitted NDA to FDA
Investigational first in class treatment for Dry Eye Disease (DED) associated with Meibomian Gland Dysfunction (MGD)
Consistent statistically significant efficacy, safety and tolerability have now been demonstrated in two Phase 3 studies of
NOV031 and one Phase 2 study
Statistically significant difference of sign and symptom was noted at day 15 and 57 in both Phase 3 studies
Current Market
. DED is one of the most common ocular surface
disorders, with approximately 18M Americans
diagnosed with DED.2,3
In one study, it was found that approximately 86%
of patients with DED had MGD involvement.4
U.S. Prescription Dry Eye Market Growth
~24%
CAGR
2016-20217
BAUSCH + LOMB
Expect Double
Digit Growth
2021-20278
Decrease from
Baseline (%)
Second Phase 3 (MOJAVE) Efficacy Endpoints:
Total Corneal Staining (sign) and Ocular Dryness (symptom) at Day 57
Total Corneal Staining 5 (ITT6)
Ocular Dryness 5 (ITT6)
N=311
-33.3%
p<0.001
NOV03
N=309
-15.8%
Saline
N=311
-45.4%
p<0.001
■NOV03
1. In 2019, the Company acquired an exclusive license from Novaliq GmbH for the commercialization and development of NOV03 in the United States and Canada.
2. Leonardi, A., Modugno, R. L., & Salami, E. (2021). Allergy and Dry Eye Disease. Ocular immunology and inflammation, 29(6), 1168-1176. https://doi.org/10.1080/09273948.2020.1841804
3. 2020 Dry Eye Products Market Report: A global Analysis for 2019 to 2025. Market Scope. Retrieved from https://www.market-scope.com/pages/reports/250/2020-ophthalmic-landscape-report-global-analysis-for-2019-to-2025-april-2021#reports.
4. Lemp, M. A., Crews, L. A., Bron, A. J., Foulks, G. N., & Sullivan, B. D. (2012). Distribution of aqueous-deficient and evaporative dry eye in a clinic-based patient cohort: a retrospective study. Cornea, 31(5), 472-478. doi: 10.1097/ICO.0b013e318225415a.
5. P-value for the difference in Least Squared Means.
6. Intent-to-treat.
7. IQVIA NSP.
8. Clarivate
N=309
-29.8%
Saline
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