NEWSspectrum

IKA Now Accepting Membership Applications

The International Keratoconus Academy of Eye Care Professionals (IKA), an organization established to promote ongoing professional education and scientific development in the area of keratoconus and other forms of corneal ectasia, announced that it is now accepting applications for membership at www.keratoconusacademy.com and that the first year membership dues are complimentary.

IKA plans to promote the awareness and understanding of the most appropriate and effective treatment strategies for the management of these diseases. According to the organization, it will accomplish this by providing an array of educational initiatives that will include live events, web-based education, social media activities, and publications in the professional literature. It will also be dedicated to supporting ongoing clinical research.

The founding executive board includes S. Barry Eiden, OD, FAAO; Andrew Morgenstern, OD, FAAO; Timothy McMahon, OD, FAAO; Joseph Barr, OD, MS, FAAO; William Tullo, OD, FAAO; Clark Chang, OD, FAAO; Eric Donnenfeld, MD; and Yaron Rabinowitz, MD. An international physician’s advisory board of expert optometrists and ophthalmologists is being formed.

Alcon Names Merchea Head of Medical Affairs for Vision Care

Alcon, a division of Novartis, has appointed Mohinder (Mo) Merchea, OD, PhD, MBA, as head of Medical Affairs for Vision Care in the United States and Canada.

In his new role for Alcon, Dr. Merchea will develop strategic scientific plans for brands in the Vision Care franchise, with a focus on the needs of patients, the medical and scientific communities, and regulatory authorities. Dr. Merchea will lead regional strategy for Phase IIIb and Phase IV trials in the United States and Canada. In addition to contributing to medical communication, publication, and key conference plans, Dr. Merchea will oversee independent medical education programs for Alcon’s clinician partners.

Dr. Merchea brings more than 18 years of experience in eye health, clinical research, and medical device development. He previously had a 12-year career at Bausch + Lomb, a division of Valeant Pharmaceuticals Inc., as the head of Medical Affairs, Vision Care; and most recently at Lensar Inc., where he served as the vice president of Clinical & Regulatory Affairs.

Dr. Merchea is a cornea and contact lens specialist with experience designing and executing developmental and post-market clinical trials and laboratory studies. He has supported regulatory submissions, product safety monitoring, and quality assurance for contact lens and surgical devices. He is also experienced in supporting commercial organizations in competitive strategy and tactics, claims development for medical device marketing, key opinion leader strategy, and promotional review.

Dr. Merchea will be based in Fort Worth, Texas.

Naidoo Appointed CEO, BHVI

The board of the Brien Holden Vision Institute (BHVI) has announced the appointment of Professor Kovin Naidoo to the position of CEO. Professor Naidoo was appointed interim CEO following the passing of Professor Brien Holden in July 2015.

Chair of the board Professor Brian Layland, OAM, said the appointment vindicates the outstanding leadership that Professor Naidoo has brought to the role in an interim capacity and his long history of exemplary service to the Institute.

Professor Naidoo is supported by an executive group of Yvette Waddell (COO, BHVI) Dr. Paul Erickson (Head of Research and Development and CEO, Brien Holden Vision Pty Ltd), Amanda Davis (COO, BHVI Public Health), and Dr. Kah Ooi Tan (CEO, BHVI China).

Positive Results for Dry Eye Treatment

Auven Therapeutics announced results from its Phase 2b/3 clinical trial evaluating the safety and efficacy of Seciera (OTX-101). Seciera is a novel, investigational nanomicellar formulation of cyclosporine utilizing patent-protected proprietary technology to enhance penetration into target tissues of the eye. Unlike other ocular formulations of cyclosporine, Seciera is a clear, preservative-free, isotonic aqueous solution.

The 455-patient randomized, double-masked, vehicle-controlled, dose-ranging study (ClinicalTrials.gov Identifier: NCT02254265) was conducted at 28 U.S. investigational sites. In the study, both concentrations (0.05% and 0.09%) of Seciera demonstrated statistical superiority over placebo-vehicle for the co-primary efficacy endpoint of change from baseline at week 12 in total conjunctival lissamine green staining. The study also demonstrated superiority to placebo-vehicle in tear production and in corneal fluorescein staining (total and inferior) at week 12 for both concentrations. Additionally, the 0.09% dose of Seciera demonstrated superiority to placebo-vehicle in a responder analysis of tear production (≥ 10mm increase in Schirmer’s test) and in central and temporal corneal staining.

In accordance with guidance received from the U.S. Food and Drug Administration, a single additional Phase 3 trial will be conducted to confirm the significant, clinically meaningful increase in tear production seen in the Phase 2b/3 trial and the large reduction in signs of ocular surface inflammation compared to placebo-vehicle. A long-term safety study will be initiated concurrently. Enrollment for both studies is planned to begin in early 2016. If these studies are successful, the submission of a New Drug Application for Seciera for treatment of dry eye disease is anticipated in early 2017.