Drug Delivery

Looking to excel in the high-growth area of Ocular Drug Delivery and meet unmet needs? Look to Ora - the leading Ophthalmic Preclinical and Clinical CRO and your regulatory, strategic development, and clinical resource.

While the eye is readily accessible, drug delivery to the eye presents a challenge. The eye’s structure, function, and biochemistry make it highly impervious to drug penetration and retention. Topical administrations often require frequent applications over indefinite periods of time, while direct injection of a drug can present adverse events related to the procedure; and both options present issues with long-term patient compliance.

These challenges are fueling the rapidly expanding field of ophthalmic drug delivery, compelling multinational pharmaceutical companies and emerging companies alike to develop innovative methods for better delivery of ophthalmic drugs. Ora is at the forefront of ophthalmic drug delivery development with 34 FDA drug approvals across the ophthalmic category, making us a trusted resource for companies around the world.

Front of the Eye Back of the Eye Post Surgical Glaucoma
  • Iontophoresis
  • Contact Lenses
  • PLGA inserts
  • PLGA
  • Drug Depots
  • Microspheres
  • Implants
  • Punctal Plugs
  • Collagen Inserts
  • Nanoparticles

Our product development experience spans from early stage product development up to Phase III pivotal studies. We have assisted our clients in developing products within these areas of drug delivery:

  • Contact Lenses: Ora works with leading lens manufacturers to develop lens/drug combinations using our CAC and CAE chamber models. We pioneered the unique regulatory pathway for approvals in this developing market.
  • Collagen Inserts: We are currently working on a sustained release program aimed at Glaucoma. Our significant preclinical experience and MOA understanding help our clients reach development and valuation milestones.
  • Punctal Plugs: We’re helping to develop the regulatory pathway and product development of new materials in punctual plug designs that are targeted at anti-infective and anti-inflammatory pathways.

Regulatory Expertise

Over the next five years, patent expiration in the ocular space will increase. We can help you evaluate which compounds to consider for sustained delivery platforms. Our years of clinical experience can provide you with a greater understanding of your target drug substance and your delivery system, and how to navigate the regulatory pathway.

Regulatory Services include:
  • Identifying the right combination of the delivery system and the chosen active compound
  • How your MOA defines your regulatory path
  • Pre-IND Package and Development of Protocol
  • Complete regulatory filing capabilities
  • Integration of CSRs into the NDA or PMA as needed

 

Strategic Development

Our experts will help you to identify and capitalize on expiring IPs; provide target identification and indication selection; uphold technical and business due diligence; develop and implement preclinical and clinical strategies.

We work to support our clients throughout the product development process with a full suite of tailored services:
  • Strategic Consulting – e.g., capitalizing on the expiring IP of well characterized pharmaceuticals
  • Target identification and indication selection
  • Technical and business due diligence
  • Preclinical development strategy and turnkey study management
  • Clinical development strategy, study design and turnkey study management
  • Comprehensive regulatory consulting, interface with international regulatory agencies, briefing package preparation, and ongoing regulatory support

 

As a resource for our clients, we provide knowledge and insights crucial to answering key development questions, including:
  • What is sought by potential strategic partners?
  • Which preclinical and clinical studies are needed to show the most value to strategic partners?
  • How should these studies be designed?
  • What needs to be demonstrated in these studies?
  • What are the regulatory standards to which these studies need to adhere?

 

Clinical Value

Ora is especially adept at mitigating the risk that is so often associated with the development of novel ophthalmic drug delivery methods.

We have a proven track record in guiding clients through a complete range of development challenges:
  • Formulation and stability challenges
  • Missed product development timelines
  • Dose ranging for therapeutic significance
  • Identifying proper drug compounds
  • Developing proper surgical techniques for implantation or injection of a device