Bausch + Lomb reports statistically significant data on novel dry eye supplement

Bausch + Lomb Corporation announced promising data published in Frontiers in Ophthalmology supporting the safety and efficacy of its novel daily nutritional supplement formulated to address dry eye symptoms: Blink NutriTears.

Is this a new product?

Yes—for B+L, at least. The product joins the company’s already extensive dry eye portfolio of various ophthalmic and contact lens topical formulations, including:

MIEBO (perfluorohexyloctane ophthalmic solution)
- FDA-approved in May 2023 as the first and only dry eye disease (DED) treatment directly targeting tear evaporation
Xiidra (lifitegrast ophthalmic solution) 5%
- FDA-approved in 2016
- Targets inflammation
- Acquired from Novartis in June 2023

Gotcha. Now explain the Blink brand.

Blink NutriTears is B+L’s newest addition to the Blink product line of eye and contact lens drops, which it acquired through an affiliate in July 2023. (Read our coverage here.)

Six varieties of eye drops and contact lens rewetting drops are included in the brand’s portfolio:

What’s unique about the Blink drops?

The drops are formulated to provide long-lasting symptom relief of burning, irritation, and discomfort due to dry eyes caused by exposure to wind or sun by restoring eye tears’ natural salt balance.

Click here to learn more about the Blink drops ingredients.

Now talk about this new supplement.

Per B+L, Blink NutriTears is a daily nutritional supplement (670 mg softgel capsule) created with a proprietary blend of ingredients, including:

Lutein
Zeaxanthin isomers
Curcumin
Vitamin D3

Is it commercially available yet?

Not quite! The company expects to launch the supplement in the United States by the early part of Q3 2024.

I see. Let’s move on to this study.

The prospective randomized, double-blind, parallel, placebo-controlled study was designed to assess the safety and efficacy of the NutriTears supplement in 155 participants (diagnosed with mild dry eye symptoms; aged 18-65; median age of 42).

The setup: Patients were randomized to be given either the NutriTears supplement (n = 77) or a placebo capsule of soybean oil (n = 78)
The duration: Once per day in the morning for 56 days (eight weeks)
- Note: Study involved a 7-day screening period, 56-day treatment period, and an end-of-study visit at 56 + 3 days
  - Follow-up visits conducted at days 14, 28, and 56
- Also: Captured artificial tear use during this time

What was measured?

The primary endpoints included:

Change in tear production
Change in participant reports of dry eye symptoms

Secondary endpoints included:

Tear break-up time (TBUT) and standard patient evaluation of eye dryness (SPEED)
- Evaluated at: baseline and days 14, 28, and 56
Corneal and conjunctival staining, tear osmolarity, and presence of MMP-9
- Evaluated at: baseline and Day 56

And the findings?

Out of the total 156 participants, 116 completed the study:

NutriTears group: 57 patients (74%)
Placebo group: 59 participants (76%)

Start with the primary endpoints.

Per the company, the study met both primary outcomes, with NutriTears patients demonstrating “significant improvements in tear production, as measured by change in Schirmer’s test scores from baseline compared to placebo to day 56 (p<0.001 for both).”

How did OSDI scores rate?

Total ocular surface disease index (OSDI) scores—plus symptoms and vision domains of the OSDI—were reported to be “significantly improved for participants consuming the daily NutriTears versus placebo, (p<0.05 for all) by day 14.”

Also: These scores were maintained to day 56 (p<0.001).

Moving on to secondary endpoints …

By day 56, significant improvements were noted for the NutriTears group in:

Ocular surface staining
Patient-reported dry eye symptoms
Inflammatory marker MMP-9
TBUT and tear osmolarity (vs placebo [p<0.001])

What else?

Study authors noted significant improvements among NutriTears participants at at day 56 in corneal and conjunctival staining (p<0.001 for both) as well as inflammation.

And for patient-reported ocular dry eye symptoms?

By day 14, both patient-reported dry eye symptoms and experience (frequency and severity) were significantly improved for NutriTears participants vs placebo (p<0.05 for days 14 and 28) and maintained to day 56 (p<0.001).

Any adverse events?

While the NutriTears supplement was found to be well-tolerated with no serious adverse events (AEs), two AEs were reported:

Increased nasal bleeding (one NutriTears patient)
Increased blurred vision (one placebo patient)

What did the study authors have to say about this?

The authors concluded that the use of NutriTears provides anti-inflammatory and antioxidant nutritional support to DED patients by “improving their experience of symptoms, addressing the characteristic loss of tear homeostasis, and ameliorating the ocular inflammation and damage that are the basis of DED pathophysiology.”

And lastly?

NutriTears investigator Neda Gioia, OD, CNS, noted that the data suggests the supplement may help to restore tear film homeostasis by addressing dry eye’s key root causes.

“This could represent a significant opportunity for consumers looking for options when it comes to long-lasting dry eye symptom relief,” stated Dr. Gioia, also the founder of Integrative Vision and president of the Ocular Wellness & Nutrition Society.