Paul Gomes, MS, Vice President, Allergy & Blepharitis
Andy Whitlock, PhD, Vice President of Preclinical Research & Development
Blepharitis is a common inflammatory disease of the eyelids and the conjunctiva. Eye care clinicians report that a high percentage of the patients they see have the condition. Since so many patients stand to benefit – and there are no treatments specifically approved for the condition – blepharitis represents a promising area for drug development.
Blepharitis is a chronic condition without a single definitive cause. Blepharitis may be associated with bacterial infection, allergy, meibomian gland obstruction, and/or demodex mite infestation in the eyelashes. Blepharitis affects people of both genders and all ages. It is more prevalent in those aged 50 years and older. Blepharitis especially in cases in which the meibomian glands are affected is strongly associated with dry eye. It is characterized by inflammatory flare-ups whose severity increases with age. Signs and symptoms of this condition include:
There are limited existing options for blepharitis treatment, which center around lid hygiene. The current standard of care includes lid scrubs with mild soap or baby shampoo, pulse steroids, as well as topical and oral antibiotics. Eye care clinicians estimate that 37 – 47% of their patients who are experiencing ocular discomfort or irritation have blepharitis, so there’s a large unmet need.
Ora has more than 40 years of experience in ophthalmic clinical development, with a focus on continuously establishing and refining clinical models and endpoints to standardize and improve clinical trial design and processes. Ora originally developed the Ora-CAC® and Ora-CAE® models to support customers with their development of ocular allergy and dry eye products, respectively. This methodology combined with Ora’s concierge like approach assisting sites support the block enrollment of clinical trial participants and enables faster enrollment at fewer sites and often a lower number of patients providing a higher quality dataset.
Over the years, Ora has sponsored observational clinical trials to better understand the epidemiology and natural disease progression of various anterior segment conditions such as allergic conjunctivitis, dry eye, blepharitis, idiopathic ocular redness, and lid swelling. By amassing a library of digital images and patient symptom data, Ora has been able to develop its own standardized sign and symptom scales to better evaluate these diseases. Ora’s scales have a proven track record of reducing variability and enhancing investigational product efficacy outcomes. Consistent and thorough training of these scales by Ora to patients and clinicians is a critical component of the Ora System.
Key operational considerations when executing on a clinical development program include:
Ora’s standardized scales for multiple ocular conditions including blepharitis, dry eye, and allergy help site staff – across all sites, using the same criteria – correlate severity in a way that was challenging in the past, with easily graded assessments of disease using photos of patients’ eyes. Another differentiator is Ora’s frequent engagement with regulatory authorities across the ophthalmic spectrum. The knowledge and insights gained support the strategies we deploy with our customers and their programs. Ultimately, the Ora team will work closely with the sponsor to design the most efficient studies with scales and endpoints to facilitate the greatest likelihood of study success.
At Ora, we continually strive not only to demonstrate drug efficacy but also to improve the quality of ophthalmic research by reducing “noise” and variability. Ora, has made it possible to know that sites are adhering to protocol through verification and the support of a team who has spent 40 years perfecting the execution of ophthalmic clinical development. This can significantly reduce much of the risk in the clinical development of blepharitis trials.
In addition to de-risking a program by streamlining and optimizing the clinical process, many times a program can be de-risked early in development through careful use of relevant preclinical disease models. Blepharitis is a multifactor disease, and thus it is hard to recapitulate in its entirety in a single animal model. Ora’s preclinical team have multiple animal models exploring individual components of the disease such as inflammation. These preclinical models can also be used to confirm safety, efficacy and bioavailability following ocular reformulation of preexisting anti-inflammatory or ant-infective drugs.
Paul Gomes is Vice President of Allergy & Blepharitis at Ora and has been with the company since 1998. He began his Ora journey as a clinical trial patient in an ocular allergy study, and that experience inspired him to make a career improving the lives of patients like him. In addition to overseeing all programs in allergy, Paul’s guidance and insight into new and developing research in ocular allergy allows Ora to be at the forefront of development in an ever-changing industry. In his time at Ora, Paul has played an integral part in the development and approval of 19 FDA products, such as Pataday, Pazeol, Bepreve, Lastacaft, and the most recent Zerviate approval.
Andy Whitlock, PhD, is Vice President of Preclinical Research & Development at Ora. Dr. Whitlock oversees all aspects of preclinical development for both internally-funded and client-sponsored ophthalmic development projects, from early PK and proof-of-concept studies through IND-enabling studies. Dr. Whitlock combines his robust therapeutic knowledge with his experience in executing preclinical research studies to deliver great value to clients in early stages of development. In addition to overseeing Ora’s internal laboratories, Dr. Whitlock has developed long-standing relationships with leading basic scientists and lab facilities to provide Ora and its clients with unique access to some of the most advanced and appropriate animal models.