ORA Dry-Eye System Supports Two Largest Exits in Dry Eye

Andover, Mass. – Ora, Inc., the world’s leading independent, full-service ophthalmic contract research organization (CRO) and product development firm, announced today its support of two dry eye exits in 2013 valuing in excess of a billion dollars for its clients.

In July, the global eye health company Bausch + Lomb announced that it acquired an option to license Mimetogen’s MIM-D3, an investigational compound currently in phase 3 development for the treatment of dry eye. Most recently, Mimetogen announced the initiation of a phase 3 clinical trial, being conducted by Ora, with MIM-D3.

“Working with Ora on many dry eye candidates in clinical trials for over 10 years has proven an incredible learning opportunity and practice builder,” said Joel A. Geffin, MD, of The Eye Care Group Waterbury, CT, an investigator in Mimetogen’s clinical development program. “This molecule is very different than previous candidates; MIM-D3 offers a unique mechanism differentiated from other late-stage candidates, both past and present. Dry eye is a complex disease: we must be able to offer an agent that is more than just an anti-inflammatory.”

MIM-D3 is the first in a class of molecules called TrkA agonists. MIM-D3 stimulates the production of mucin, which plays a critical role in the protection and overall health of the ocular surface.

Garth Cumberlidge, PhD, Chief Executive Officer, Mimetogen, comments: "Utilizing Ora’s Dry Eye System allowed us to control multiple factors that caused other programs to fail - such as completing the study within one season. Ora’s process enables us to shorten the timeline to market and is only accomplishable through the use of their Dry Eye System. The commencement of patient enrollment in our Phase 3 trial was a significant milestone for us. Completing enrollment of 50% of patients just 6 weeks later reinforced our decision to work with Ora on this important study. This is an imperative step towards realizing our ultimate goal: making this novel therapy available to millions of dry eye patients.”

Ora’s Dry Eye System addresses the challenges of studying dry eye disease, such as environmental and seasonal variability, through a combination of scientific and operational methods. Ora’s Dry Eye System integrates highly trained site-level operations support, mobile and stationary Controlled Adverse Environment (CAESM) Chambers, validated Ora Calibra™ Scales and a subject recruiting system that allows for high-density block enrolment across Ora’s network of clinical investigator sites (OraNET).

Due to the rapidly growing demand for late stage clinical development in dry eye, Ora has made a significant investment to expand the capacity for dry eye research including the expansion of the mobile CAESM fleet. Currently, Ora is enrolling over 100 patients per month in both traditional environmental and CAESM-based programs.

“I’m very pleased that the technologies that we have been developing to improve the study of dry eye disease have allowed clients to consistently demonstrate the efficacy of their novel therapies,” said Stuart Abelson, President + CEO, Ora, Inc. “After 20 years of working with this very challenging disease, we understand when and how to best integrate our unique technology based solutions to ensure our clients the best chance for success.”

Track Record in Ophthalmology

Over 30 years, Ora has established itself as a full-service ophthalmic development facility able to guide clients from molecule to marketplace. Ora utilizes a staff of 110, including 6 ophthalmologists and 15 PhDs, in addition to a global network of ophthalmic investigators. Ora’s experienced staff, adherence to protocol and ability to meet timelines bring unprecedented competitive advantage to clients.

To date, Ora is or has been:

  • Integrally involved in the development, clinical testing and regulatory interface for 19 ophthalmic anti-allergy drugs now on the market.
  • Running more than 90% of the drugs in clinical evaluation for dry eye.

Strategizing, designing and executing international investigational pre-clinical and clinical programs in every major ophthalmic indication for drugs and devices, including: allergy, age-related macular degeneration (wet and dry), anti-infective, anti-inflammatory, blepharitis, diabetic macular edema, dry eye, glaucoma, presbyopia and diagnostic, surgical and refractive medical devices.

  • Centrally involved in the development of one third of the ophthalmic pharmaceuticals currently on the world market.

About Ora, Inc.

Ora is the world’s leading independent, full-service ophthalmic CRO and product development firm with offices in the United States and Japan. Over the past 30 years, we helped our clients earn 34 FDA approvals. We support a wide array of organizations, from start-ups to global pharmaceutical and device companies, to efficiently and successfully bring their new products from concept to market. Ora’s pre-clinical and clinical models, unique methodologies and regulatory strategies have been refined and proven across thousands of projects both in the US and internationally. We bring together the world’s most extensive and experienced network of ophthalmic experts and R&D professionals to maximize the value of new product initiatives.