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Bausch (BHC) Begins Second Phase III Study on NOV03 for DED

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Bausch Health Companies Inc. (BHC - Free Report) announced that it has initiated a second phase III study, which is evaluating its first-in-class investigational treatment NOV03 (perfluorohexyloctane) for addressing the signs and symptoms of dry eye disease (DED) associated with Meibomian gland dysfunction (MGD).

Notably, the first phase III study on NOV03 is currently ongoing and already achieved 85% of the enrollment target for the same.

The investigational, water-free and preservative-free solution NOV03 is being developed to treat DED, a chronic and serious disease of the ocular surface. NOV03 met the primary efficacy endpoint in a phase II study by demonstrating statistically significant improvement of total corneal fluorescein staining over the control arm at eight weeks of treatment. Moreover, treatment with NOV03 led to statistically significant improvement in symptoms, such as severity and frequency of dryness as well as burning of the eyes.

Importantly, there was no notable safety event observed in the phase II study on NOV03.

Per the company, upon potential approval, NOV03 might become the first pharmaceutical therapy for treating patients with DED associated with MGD in the United States. An estimated 16 million people suffer DED in the United States.

Shares of Bausch have plunged 35.7% so far this year compared with the industry’s decrease of 2.3%.

price chart for BHC


We note that several companies are developing their products for the treatment of DED.

In October 2020, Aerie Pharmaceuticals, Inc. (AERI - Free Report) initiated the phase IIb study COMET-1 on its product candidate AR-15512 eye drop for the treatment of DED. Top-line results from the same are expected in the third quarter of 2021.

Meanwhile, pharma giant AbbVie’s (ABBV - Free Report) Restasis (added to its portfolio with the acquisition of Allergan) is already marketed for the treatment of DED.

Zacks Rank & Key Pick

Bausch currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the same sector is Homology Medicines, Inc. (FIXX - Free Report) , which has a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Homology Medicines’ loss per share estimates have narrowed 6.3% for 2020 and 9.3% for 2021 over the past 60 days.

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