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Bausch's (BHC) NOV03 for Dry Eye Disease Meets Study Goal
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Bausch Health’s (BHC - Free Report) global eye health business Bausch + Lomb announced positive top-line data from the phase III MOJAVE study evaluating its novel investigational drug, NOV03 (perfluorohexyloctane), for the treatment of dry eye disease (“DED”) associated with Meibomian gland dysfunction (“MGD”).
The study enrolled 620 participants who were randomized to receive either NOV03 or placebo four times daily. Data from the study demonstrated that NOV03 achieved statistical significance over placebo in both primary sign and symptom endpoints. While the primary sign was measured by changes from baseline in total Corneal Fluorescein Staining to assess eye damage, the changes from baseline in Dryness score fulfilled the criteria for symptom endpoints.
The study also met all secondary endpoints, which demonstrated statistically significant improvements of the drug over placebo in each sign and symptom of DED associated with MGD, which the MOJAVE study evaluated.
Bausch expects to file a new drug application with the FDA for NOV03 for the given indication in 2022.
Bausch’s shares have risen 33.9% so far this year against the industry’s 9.4% decline.
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We inform investors that Bausch out-licensed rights for NOV03 from Germany-based Novaliq in 2019.
The MOJAVE study is the second phase III study evaluating NOV03 for the given indication. Per FDA, drugs developed for the treatment of DED are required to demonstrate safety and efficacy in at least two independent studies. Data from the MOJAVE study supports the data from the first phase III GOBI study, which also evaluated the drug for DED associated with MGD. The GOBI study achieved both primary and secondary endpoints.
Bausch anticipates the NOV03 clinical development program to conclude with the ongoing 12-month open-label safety extension KALAHARI study.
MGM-associated DED is a common ocular disorder affecting millions of people. If approved and successfully commercialized, NOV03 in the given indication will lead to impressive revenue prospects for the company in the long run.
Bausch currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech/drug sector include Ironwood Pharmaceuticals (IRWD - Free Report) , Moderna (MRNA - Free Report) and Regeneron Pharmaceuticals (REGN - Free Report) . While both Ironwood and Regeneron sport a Zacks Rank #1 (Strong Buy) at present, Moderna currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Ironwood’s earnings per share estimates for 2021 have increased from $1.21 to $1.27 in the past 60 days. The same for 2022 has risen from $1.20 to $1.43 over the same period. The stock has rallied 14.7% in the year so far.
Moderna’s earnings per share estimates for 2021 have increased from $25.60 to $29.13 in the past 60 days. The same for 2022 has risen from $17.70 to $26.12 over the same period. The stock has rallied 268.4% in the year so far.
Regeneron’s earnings per share estimates for 2021 have increased from $49.91 to $61.41 in the past 60 days. The same for 2022 has risen from $40.91 to $46.73 over the same period. The stock has rallied 25.3% in the year so far.
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Bausch's (BHC) NOV03 for Dry Eye Disease Meets Study Goal
Bausch Health’s (BHC - Free Report) global eye health business Bausch + Lomb announced positive top-line data from the phase III MOJAVE study evaluating its novel investigational drug, NOV03 (perfluorohexyloctane), for the treatment of dry eye disease (“DED”) associated with Meibomian gland dysfunction (“MGD”).
The study enrolled 620 participants who were randomized to receive either NOV03 or placebo four times daily. Data from the study demonstrated that NOV03 achieved statistical significance over placebo in both primary sign and symptom endpoints. While the primary sign was measured by changes from baseline in total Corneal Fluorescein Staining to assess eye damage, the changes from baseline in Dryness score fulfilled the criteria for symptom endpoints.
The study also met all secondary endpoints, which demonstrated statistically significant improvements of the drug over placebo in each sign and symptom of DED associated with MGD, which the MOJAVE study evaluated.
Bausch expects to file a new drug application with the FDA for NOV03 for the given indication in 2022.
Bausch’s shares have risen 33.9% so far this year against the industry’s 9.4% decline.
We inform investors that Bausch out-licensed rights for NOV03 from Germany-based Novaliq in 2019.
The MOJAVE study is the second phase III study evaluating NOV03 for the given indication. Per FDA, drugs developed for the treatment of DED are required to demonstrate safety and efficacy in at least two independent studies. Data from the MOJAVE study supports the data from the first phase III GOBI study, which also evaluated the drug for DED associated with MGD. The GOBI study achieved both primary and secondary endpoints.
Bausch anticipates the NOV03 clinical development program to conclude with the ongoing 12-month open-label safety extension KALAHARI study.
MGM-associated DED is a common ocular disorder affecting millions of people. If approved and successfully commercialized, NOV03 in the given indication will lead to impressive revenue prospects for the company in the long run.
Bausch Health Cos Inc. Price
Bausch Health Cos Inc. price | Bausch Health Cos Inc. Quote
Zacks Rank & Key Picks
Bausch currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech/drug sector include Ironwood Pharmaceuticals (IRWD - Free Report) , Moderna (MRNA - Free Report) and Regeneron Pharmaceuticals (REGN - Free Report) . While both Ironwood and Regeneron sport a Zacks Rank #1 (Strong Buy) at present, Moderna currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Ironwood’s earnings per share estimates for 2021 have increased from $1.21 to $1.27 in the past 60 days. The same for 2022 has risen from $1.20 to $1.43 over the same period. The stock has rallied 14.7% in the year so far.
Moderna’s earnings per share estimates for 2021 have increased from $25.60 to $29.13 in the past 60 days. The same for 2022 has risen from $17.70 to $26.12 over the same period. The stock has rallied 268.4% in the year so far.
Regeneron’s earnings per share estimates for 2021 have increased from $49.91 to $61.41 in the past 60 days. The same for 2022 has risen from $40.91 to $46.73 over the same period. The stock has rallied 25.3% in the year so far.