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Bausch + Lomb announced statistically significant results from a clinical study on a novel daily nutritional supplement for dry eyes. The supplement, Blink NutriTears, showed improvements in tear production, ocular symptoms, tear-film break-up time, osmolarity, and ocular surface health. The study included 155 adult participants and met all primary and secondary endpoints, with no serious adverse events reported. The supplement is expected to be launched in the U.S. in the third quarter of 2024.
Bausch + Lomb ha annunciato risultati statisticamente significativi da uno studio clinico su un nuovo integratore alimentare quotidiano per gli occhi secchi. L'integratore, Blink NutriTears, ha mostrato miglioramenti nella produzione di lacrime, sintomi oculari, tempo di rottura del film lacrimale, osmolarità e salute della superficie oculare. Lo studio ha coinvolto 155 partecipanti adulti e ha raggiunto tutti gli endpoint primari e secondari, senza segnalare eventi avversi gravi. Si prevede che l'integratore sarà lanciato negli Stati Uniti nel terzo trimestre del 2024.
Bausch + Lomb anunció resultados estadísticamente significativos de un estudio clínico sobre un nuevo suplemento nutricional diario para ojos secos. El suplemento, Blink NutriTears, mostró mejoras en la producción de lágrimas, síntomas oculares, tiempo de ruptura de la película lagrimal, osmolaridad, y la salud de la superficie ocular. El estudio incluyó a 155 participantes adultos y cumplió con todos los puntos finales primarios y secundarios, sin eventos adversos graves reportados. Se espera que el suplemento se lance en EE. UU. en el tercer trimestre de 2024.
바우쉬 + 롬은 건조한 눈을 위한 새로운 일일 영양 보충제에 대한 임상 연구에서 통계적으로 유의미한 결과를 발표했습니다. 이 보충제인 Blink NutriTears는 눈물 생산, 안구 증상, 눈물막 파열 시간, 삼투압, 그리고 안구 표면 건강의 개선을 보였습니다. 연구는 155명의 성인 참가자를 포함하였으며 모든 1차 및 2차 최종목표를 충족하였고, 심각한 부작용은 보고되지 않았습니다. 이 보충제는 2024년 3분기에 미국에서 출시될 예정입니다.
Bausch + Lomb a annoncé des résultats statistiquement significatifs d'une étude clinique sur un nouveau complément nutritionnel quotidien pour les yeux secs. Le complément, Blink NutriTears, a montré des améliorations dans la production de larmes, les symptômes oculaires, le temps de rupture du film lacrymal, l'osmolarité et la santé de la surface oculaire. L'étude a inclus 155 participants adultes et a atteint tous les critères d'évaluation primaires et secondaires, sans aucun événement indésirable grave signalé. Le complément est prévu pour être lancé aux États-Unis au troisième trimestre de 2024.
Bausch + Lomb gab statistisch signifikante Ergebnisse einer klinischen Studie über ein neues tägliches Nahrungsergänzungsmittel für trockene Augen bekannt. Das Nahrungsergänzungsmittel, Blink NutriTears, zeigte Verbesserungen bei der Tränenproduktion, okularen Symptomen, der Tränenfilm-Aufrisszeit, der Osmolarität und der Gesundheit der Augenoberfläche. Die Studie umfasste 155 erwachsene Teilnehmer und erreichte alle primären und sekundären Endpunkte, ohne dass schwerwiegende unerwünschte Ereignisse gemeldet wurden. Es wird erwartet, dass das Ergänzungsmittel im dritten Quartal 2024 in den USA eingeführt wird.
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Insights
The study's successful outcome positions Blink NutriTears as a potentially disruptive entrant in the dry eye supplement market. Tear production and OSDI score improvements signal considerable efficacy that can translate into high consumer adoption rates, especially among tech-savvy, younger demographics increasingly affected by dry eye symptoms. However, the long-term commercial success hinges on consumer experience beyond the controlled environment of clinical trials. Investors should monitor consumer feedback post-launch, as early adoption trends often set the trajectory for sustained sales momentum. The absence of serious adverse events is noteworthy and enhances the product's safety profile, a critical factor that can influence both market approval processes and consumer confidence.
Bausch + Lomb's market positioning could be significantly strengthened by the introduction of Blink NutriTears, especially given the large addressable market of 150 million potential customers in the U.S. alone. The announcement may lead to positive investor sentiment, reflected in stock valuation in anticipation of the product launch. Notably, the timing of the launch in Q3 2024 allows for strategic marketing build-up. However, investors should consider the potential for market saturation and competitive responses. Revenue projections should factor in the pace of market penetration, pricing strategy and reimbursement scenarios, if applicable. It will be important to track the company's R&D and marketing expenditures to gauge the impact on the bottom line in subsequent fiscal periods.
The innovation in dry eye treatment with a focus on nutritional supplementation reflects an evolving consumer preference for proactive and holistic health management. The inclusion of ingredients like lutein and curcumin aligns with current health trends and may bolster the product's appeal. The lack of significant artificial tear usage difference between the NutriTears and placebo groups suggests that the supplement could serve as a primary intervention rather than an adjunct therapy. Market dynamics will likely respond favorably to a non-invasive, dietary approach to eye care. As the ophthalmic supplement landscape expands, differentiation through clinically validated results, such as those demonstrated by NutriTears, will be key to capturing and retaining market share.
Novel Supplement Shown to Address Signs and Symptoms of Dry Eyes, All Primary Endpoints Achieved
VAUGHAN, Ontario--(BUSINESS WIRE)--
Bausch + Lomb Corporation (NYSE/TSX: BLCO), a leading global eye health company dedicated to helping people see better to live better, today announced Frontiers in Ophthalmologypublished statistically significant results from a clinical study evaluating the efficacy and safety of a novel daily nutritional supplement formulated to address the symptoms of dry eyes.1 Bausch + Lomb expects to launch the supplement, which features a proprietary blend of ingredients including lutein, zeaxanthin isomers, curcumin and vitamin D3, under the brand name Blink™ NutriTears® early in the third quarter of 2024 in the U.S.
The clinical study met both primary endpoints:
Change from baseline at day 56 (week eight) in tear production (Schirmer’s test).
Change from baseline at day 56 in ocular symptoms measured by OSDI score.
The study also met secondary endpoints, showing statistically significant improvements in tear-film break-up time (TBUT), osmolarity, ocular surface health and presence of an inflammatory marker.
“More than 150 million people experience dry eyes in the U.S.,” said Yehia Hashad, M.D., executive vice president, Research & Development and chief medical officer, Bausch + Lomb. “We believe Blink NutriTears will offer a novel nutritional option that can provide dry eye symptom relief in as little as two to four weeks.”
Dry eyes are a prevalent ocular surface disorder that affects millions of adults worldwide. Once a condition known to traditionally affect adults over the age of 55, dry eye is impacting a younger demographic of consumers fueled by modern-day factors such as increased digital device use, environmental stressors, anxiety and stress. Nearly 70% of consumers attribute their dry eye symptoms to digital device use.
The prospective, randomized, double-blind, parallel, placebo-controlled study evaluated the efficacy and safety of NutriTears in 155 adult participants with mild dry eye symptoms (aged 18–65; median age 42). Participants were randomized to receive one NutriTears or placebo capsule (NutriTears, n=77; placebo, n=78) per day for 56 days (eight weeks) and artificial tear use was captured.
Key points from the trial:
Primary endpoints
The study met both of its primary endpoints: Change in tear production and participant reports of dry eye symptoms.
Participants consuming the daily NutriTears had significant improvements in tear production, as measured by change in Schirmer’s test scores from baseline compared to placebo to day 56 (week eight) (p<0.001 for both).
By day 14, total OSDI scores, as well as symptoms and vision domains of the OSDI significantly improved from baseline for participants consuming the daily NutriTears versus placebo, (p<0.05 for all) and were maintained to day 56 (p<0.001).
Key secondary endpoints
Significant improvements in ocular surface staining, participant reported symptoms, and the inflammatory marker MMP-9 in participants consuming the daily NutriTears compared to placebo were seen at day 56.
By day 56, participants consuming the daily NutriTears had significantly improved TBUT and tear osmolarity, versus placebo (p<0.001).
Participants consuming the daily NutriTears supplement had significant improvements in corneal and conjunctival staining (p<0.001 for both), and inflammation, as assessed by presence of MMP-9, by day 56 (p<0.001 for each eye).
Significant improvements in participant-reported ocular symptoms of dry eyes and participant experience of the frequency and severity of dry eye symptoms, as assessed by a SPEED questionnaire, were noted by day 14 for participants consuming the daily NutriTears versus placebo (p<0.05 for days 14 and 28) and maintained to day 56 (p<0.001).
Participants were allowed to use artificial tears throughout the study; there was no difference between groups for artificial tear usage.
NutriTears was found to be well-tolerated. No serious adverse events were reported during the study period.
“These data suggest consumption of this new once-daily nutritional supplement may help restore tear film homeostasis by addressing the key root causes of dry eyes,” said Neda Gioia, OD, CNS, founder Integrative Vision, president, Ocular Wellness & Nutrition Society, and Blink NutriTears investigator. “This could represent a significant opportunity for consumers looking for options when it comes to long-lasting dry eye symptom relief.”
About the Blink Brand
Blink is a leading brand of lubricating eye drops for dry eyes and dry contacts in the United States. The portfolio is formulated to relieve dryness and discomfort in the eyes. They work by moisturizing the surface of the eye and providing relief from irritation caused by factors such as prolonged screen time, environmental conditions or contact lens wear. Bausch + Lomb plans to build upon the Blink product line later this year with Blink NutriTears clinically proven supplement for dry eyes.
About Bausch + Lomb
Bausch + Lomb is dedicated to protecting and enhancing the gift of sight for millions of people around the world – from birth through every phase of life. Its comprehensive portfolio of approximately 400 products includes contact lenses, lens care products, eye care products, ophthalmic pharmaceuticals, over-the-counter products and ophthalmic surgical devices and instruments. Founded in 1853, Bausch + Lomb has a significant global research and development, manufacturing and commercial footprint with approximately 13,000 employees and a presence in nearly 100 countries. Bausch + Lomb is headquartered in Vaughan, Ontario with corporate offices in Bridgewater, New Jersey. For more information, visit www.bausch.com and connect with us on X, LinkedIn, Facebook and Instagram.
Forward-looking Statements
This news release may contain forward-looking statements, which may generally be identified by the use of the words “anticipates,” “hopes,” “expects,” “intends,” “plans,” “should,” “could,” “would,” “may,” “believes,” “estimates,” “potential,” “target,” or “continue” and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties discussed in Bausch + Lomb’s filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. Bausch + Lomb undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.
References
Gioia, et al. A Novel Multi-Ingredient Supplement Significantly Improves Ocular Symptoms Severity and Tear Production in Patients with Dry Eye Disease: Results from a Randomized, Placebo-Controlled Clinical Trial. Front. Ophthalmol. 2024;4. doi: 10.3389/fopht.2024.1362113.
What did Bausch + Lomb announce regarding a clinical study?
Bausch + Lomb announced statistically significant results from a clinical study of a novel daily nutritional supplement for dry eyes.
What is the brand name of the novel nutritional supplement?
The novel nutritional supplement will be launched under the brand name Blink NutriTears.
What were the primary endpoints of the clinical study?
The primary endpoints of the study were the change in tear production and ocular symptoms measured by OSDI score.
What were the key secondary endpoints of the clinical study?
The key secondary endpoints included improvements in ocular surface staining, tear-film break-up time, tear osmolarity, corneal and conjunctival staining, and inflammation.
How many participants were involved in the clinical study?
The clinical study evaluated 155 adult participants with mild dry eye symptoms.
