A committed partner for ophthalmology stakeholders: from pre-formulation to market launch

Developing an ophthalmic drug requires much more than formulation stability: it means creating a safe, preservative-free solution that is aligned with new therapeutic expectations and designed for the patient.

At Unither Pharmaceuticals, we support:

Start-ups and biotechs involved in the development of new ophthalmic molecules or formulations

Pharmaceutical companies specializing in the treatment of eye diseases,

Laboratories that already have multi-dose or single-dose eye drop products,

CROs during preclinical phases.

Our mission is to transform your ideas into ophthalmic products ready for clinical and commercial manufacturing, with a tailored and pragmatic approach.

Thanks to a multi-site organization combining specialized technology platforms and pilot facilities, Unither Pharmaceuticals manages every stage of development, from pre-formulation to formulation. We then carry out scale-up until the production of the first batches.

This organization guarantees both early-phase agility and continuity through industrialization.

Ophthalmic development expertise

Blow-Fill-Seal ophthalmology

Pre-formulation and characterization of active ingredients

We start each project with an in-depth pre-formulation study, key to ensuring the product’s stability and future performance.

  • Optical microscopy, X-ray diffraction (XRD)
  • Particle size analysis (PSD)
  • Log P / Log D, membrane permeability
  • Solubility studies, cyclodextrin complexation, co-solvents, micronization
  • Container-content compatibility study
  • Manufacturing of the first preclinical batches
Développement ophtalmique

Ophthalmic formulation adapted to clinical uses and constraints

The development of eye drops requires strategic choices related to the tolerance, use, and dosage of the treatment.

At Unither Pharmaceuticals, we are proficient in multi-dose solutions, including formulations with preservatives and those that are preservative-free, which are now preferred for their better tolerance. We assist our clients in choosing the most suitable dosage format for their project, taking into account indications, treatment duration, and administration method.

We develop a wide range of formats:

  • Solutions, gels, emulsions
  • Micro- and nanoemulsions
  • Nanosuspensions

With an approach based on Quality by Design (QbD):

  • Design of experiments (JMP), risk analysis
  • Full characterization: pH, osmolality, rheology, bioadhesion
Multidoses + BFS

Guidance in choice of packaging

The choice of packaging is often fine-tuned throughout the development phases, especially during dose-ranging studies.

We advise you on the most suitable formats:

  • Single-dose BFS, ideal for ad-hoc or post-surgical treatments
  • Preservative-free multi-dose, suitable for chronic treatments requiring better tolerance
  • Multi-dose with preservatives, a proven solution for certain products, depending on markets or technical constraints
Développement analytique et contrôles qualité

Analytical development and quality controls

  • Assay of active ingredients and impurities
  • Forced degradation studies
  • Full analytical validation
Mise à l’échelle et industrialisation

Scale-up and industrialization

  • Manufacturing of clinical and pre-commercial batches
  • Process validation, robustness studies
  • Sterilization, filterability
  • ICH stability studies and ongoing monitoring
  • Extractables and leachables studies

Why choose Unither Pharmaceuticals for the development of your ophthalmic products?

Over 30 years of experience in ophthalmic formulation and production

Recognized expertise in single-dose BFS and preservative-free multi-doses

Personalized support: from preclinical vials to the first commercial batches

Our teams work with start-ups as well as specialized pharma leaders

Ability to integrate formulation, analytics, industrialization, and regulatory compliance

FAQ – Ophthalmic development

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.

Yes. Unither has structured its services to support early-stage projects by strengthening R&D teams and providing regulatory support (strategy, drafting, and dossier preparation), as well as through our ability to produce very small volumes using pilot lines and dedicated tanks.

This enables us to help start-ups, biotechs, CROs, and development companies to safely conduct initial studies, right up to transfer to a BFS or multi-dose industrial site.

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.