Development and manufacturing for ophthalmic treatments

The ophthalmic market is seeing an increase in chronic pathologies such as glaucoma and dry eye disease. Patients are looking for safer, better tolerated, and easy-to-use treatments. Unither has made this a strategic priority and is strengthening its capacities, particularly with the development of multi-dose treatments, with or without preservatives.

A global leader in Blow-Fill-Seal (BFS) technology, Unither offers sterile single doses (eye drops) that are perfectly suited to the needs of ophthalmology, thanks to a closed aseptic process without preservatives. Our innovations draw on proprietary technologies such as Sol-Gel™ and the integration of advanced solutions like Eyeleeen (based on Carragelose) to provide more effective and better-tolerated treatments.

Ophthalmic formats we can manufacture

Blow-Fill-Seal

Multi-Dose

Integrated expertise for your ophthalmic projects

Développement d'un produit ophtalmique schéma 7 étapes

Ophthalmic product development

Our ophthalmic development teams work closely with our partners to design robust formulations, validate analytical methods, and ensure aseptic manufacturing that can be adapted to the industrial scale. The process follows a clearly defined sequence:

  • Pre-formulation: API characterization, solubility optimization, compatibility, and early stability.
  • Analytical development: assay, forced degradation, sterility, and microbiological controls.
  • Formulation: design based on QbD and DoE principles for solutions, gels, emulsions, and nanosystems.
  • Sterilization: study of the impact of steam, filtration, and filterability.
  • Container/content interactions: stress studies, extractables, and leachables.
  • Scale-up: process robustness, validations, cleaning verification, and clinical batches.
  • Industrialization: small commercial batches, full validation, and stability studies
En savoir plus
BFS et multidose

Out-licensing - our documentation and turnkey products

Unither offers a comprehensive portfolio of ophthalmic products available for out-licensing, which cover the major needs of the market.

These registration-ready products allow you to accelerate your launches by benefitting from Unither’s expertise in ophthalmology, from aseptic BFS to multi-dose formats.

Licensing out
 Data table
BFS (Blow-Fill-Seal) Volume Category Status Dossier Country
Hyaluronate 0.2% 0.25mL Ocular lubricant Medical Device (ls) CE Marking Contact us
Isotonic Saline Solution 0.9% 5 mL Rhinology, Ophthalmology Medical Device (ls) CE Marking Contact us
Multi-purpose Isotonic 0.9% 5 mL Eyes, nose, ear, wound, inhalation MD (IIa) CE Marking Contact us
 Data table
Multi-dose Volume Category Status Dossier Country
Sodium Carmellose (CMC) 0.5% and 1% 10.15 ml Ophthalmic MD CE Mark Brazil, US
Sodium Hyaluronate 0.15% 10 ml Ophthalmic MD CE Mark Brazil, US
Sodium Carmellose (CMC) 0.5% + Sodium Hyaluronate 0.10% + Glycerol 0.9% 10 ml Ophthalmic MD CE Mark Brazil, US
Hyaluronic Acid 0.15% 10 ml Ophthalmic MD CE Mark Contact us
Carragelose eye drops 3.2 mg/ml 10 ml Ophthalmic MD (IIa) CE Mark Contact us

Our proprietary technologies

SOLUTIONS de rupture Sol Gel

Sol-Gel™

Sol-Gel™ is a patented technology developed by Unither to formulate liquid ophthalmic hydrogels during manufacturing, which gel directly upon contact with the tear film thanks to the presence of gellan gum. This in-situ transformation allows for smooth and comfortable application, followed by prolonged retention on the eye.

Key advantages:

  • Ease of application
  • Extended release for improved efficacy
  • High ocular bioavailability
  • Reduction in the doses of active ingredient required
  • Fewer potential side effects
  • Recognized, tried-and-tested, and well-tolerated ingredients
En savoir plus

Why trust us?

5 billion units/year

Global leader in BFS for sterile single doses, especially for ophthalmic treatments.

+30 years

of expertise in sterile and ophthalmic formulations

3 continents

(Europe, US, Brazil, China) to support registrations in EMA, FDA, ANVISA, NMPA regions.

3 L to 2,000 L flexibility

from small batches

+75 clients

Presence in ~100 countries

19 BFS machines

dedicated to ophthalmic products

Got a project?

Talk to our experts

Natalia SERVOL

Ophthalmic Division Director

Anaïs CASTEX

Business Development Manager – Ophthalmology Early Stage

Ana-Lucia DA COSTA

Business Development Manager

Brian KENYON

Business Development Manager – US

Claire COSTA

Business Development Manager

Stefanie VINING

Business Development Manager

Anne-Sophie MARIN

Business Development Manager (Bordeaux)

Got questions? - Consult our FAQ

Unither handles the full development cycle – from pre-formulation though industrialization – and assists its clients with complex projects such as preservative-free eye drops, multi-doses (with or without preservatives), Sol-Gel™ hydrogels, and medical devices. Our industrial sites on four continents optimize your supply chains and international registration strategies.

The choice of packaging format depends on the dosage and duration of treatment.
At Unither, clients can choose between:

  • Sterile and preservative-free BFS single doses — often preferred for occasional or intermediate use (e.g. post-surgery)

  • Multi-doses (with or without preservatives) — generally suitable for chronic-disease treatments such as glaucoma or dry eye

The decision is made as clinical development progresses, such as during a dose-ranging when the concentration, number of drops, and duration of treatment is defined.

BFS is a closed aseptic process that is ideal for sterile single doses and is particularly suited to sensitive formulations. As a global leader in BFS, Unither guarantees optimal sterility, high reproducibility, and safe, preservative-free eye drops that comply with international standards.

Yes. Our out-licensing portfolio includes ocular lubricants, saline solutions, multi-dose products (with or without preservatives), and Eyeleen® (Carragelose®) for dry eye, to accelerate market access.

Our patented Sol-Gel™ technology allows the formulation of liquid ophthalmic hydrogels for production, which gel upon contact with tear fluid thanks to gellan gum. This property increases patient comfort, prolongs drug release time, and offers high bioavailability. Sol-Gel™ requires less active ingredient than traditional eye drops, which limits adverse effects. The first application, Solmyd™, offers effective mydriasis in a single instillation, instead of several successive drops.

Yes — it’s one of our strengths!

Unither can manufacture very small batches to begin with and then assist with scale-up to large commercial volumes using the same techniques (BFS and multi-dose).

This flexibility allows us to offer services for both start-ups and major pharmaceutical companies, even in the case of complex processes requiring multiple manufacturing steps.