Bruder Healthcare, a Hilco Vision company, announced it will be re-branding and marketing Santen Pharmaceuticals’ Retaine MGD eye drop formulation via an exclusive distribution agreement.
First up: Bruder.
Based in Alpharetta, Georgia, the medical equipment manufacturer’s therapeutic eyecare and analgesic products fall into the following categories:
- Eyecare solutions
- Contact lens discomfort
- Hydration and eye health
- Eyelid and eyelash hygiene
- Sinus and allergy
- Blepharitis and inflammation
- Styes
- Pain relief products
- Moist heat wraps and pads
- Cold therapy wraps and pads
Any details on this agreement?
As of now, the companies have not disclosed any further information.
Gotcha. So talk about Retaine MGD.
Original U.S. launch date: 2012 via OCuSOFT, Inc.
The product: Retaine Meibomian Gland Dysfunction (MGD) ophthalmic emulsion, preservative-free (PF) eye drops are distributed as single-dose vials formulated with a lipid-replenishing formula that stabilizes the tear film and protects from moisture loss.
- Note: Outside of the United States, the eye drop is marketed as Cationorm by Santen Pharmaceuticals.
Its target: Providing moisturization, lubrication, and protection for moderate-to-severe evaporative dry eye disease (DED) due to prolonged use of contact lenses or environmental conditions.
So will OCuSOFT not be marketing Retaine in the U.S. anymore?
Per a representative from Hilco Vision Group, Santen and OCuSOFT have ended their exclusive distribution agreement for the formulation.
As a result, Bruder now holds the exclusive distribution agreement for the Retaine MGD's original formulation.
Edited to add: According to OCuSOFT, Retaine MGD is still a registered trademark of the company and will now be manufactured in the United States as well as available for purchase as Retaine MGD Advanced from OCuSOFT.
What ingredients are included in the formulation?
Based on Santen’s product: mineral oils, primarily.
See here for others.
How does it work?
The PF eye drops feature an oil-in-water cationic emulsion technology that “delivers ingredients through electrostatic attraction between positively-charged droplets and the negatively-charged ocular surface.”
- More on this technology: Dubbed “Novasorb,” the tech’s electrostaticity enables the emulsion to spread evenly over the ocular surface, while the oil droplets’ nanoscale size allows for emulsion stability and ocular absorption.
And the dosing?
Based on Santen’s directions, one or two drops should be instilled as needed.
The intended result: DED symptom relief.
Moving on to Bruder’s rebranded version …
The drop will join Bruder’s dry eye treatment portfolio as Eyeleve MGD, which features a hypotonicity-based emulsion that adds moisture by lowering tears’ salt concentration while also protecting the eye’s surface.
Its target conditions:
- Dry eye
- MGD
- Blepharitis
- Allergies
Any clinical data to support its mechanism of action?
There is! The eye drop was actually evaluated for its efficacy in research published in Clinical Ophthalmology in 2015.
The study: A single-center, open-label study investigated the use of the formulation (Retaine) in managing tear film stability and ocular surface staining among dry eye patients.
The participants: 42 patients (aged 18+) with a history of dry eye for at least 6 months.
- Criteria: Use of eye drops for dry eye symptoms or interest in using drops
The design: Twice-daily (BID), bilateral dosing of Retaine, plus:
- Two clinical visits (Day 1 and Day 14); with the following assessments conducted at each visit:
- Ocular sign and symptom assessment
- Visual acuity procedures
- Comfort assessments
The duration: 14 days.
And those findings?
By the second visit (Day 14), a statistically significant reduction in mean breakup area was noted between the predose and post-dose time (P = 0.026).
Further, by Day 14, participants demonstrated significantly less corneal fluorescein staining in the following ocular regions compared to Day 1:
- Superior (P = 0.002)
- Central (P = 0.0017)
- Corneal sum (P = 0.011)
- All ocular regions combined (P = 0.038)
Any other significant changes?
Also on Visit 2, the following reductions were noted:
- Dryness (P < 0.001)
- Grittiness (P = 0.0217)
- Ocular discomfort (P = 0.0017)
- All symptoms (P < 0.001)
Participants also reported a “statistically significant improvement in their abilities to work with a computer at night (P = 0.044),” while the mean drop comfort scores ranged from 1.28–1.81 (with 1 being very comfortable).
Any potential drawbacks?
While the study did not use a placebo for comparison, the “breadth of examinations and procedures do provide a complete picture of the benefits of the product,” the study authors stated.
Further: They acknowledged that a 2-week treatment period is short for an artificial tear—despite the treatment findings being “very encouraging and (highlighting) the fast onset of action for this compound.”
Nice! So about this Eyeleve MGD … when will it be available?
Packaged as 30 sterile, single-dose containers, the drops won’t launch until early 2025, according to Bruder.
The product will be manufactured in France, a company representative confirmed.
Stay tuned in the meantime for ordering details!