Glaucoma drug developer Aerie Pharmaceuticals Inc. hopes for Food and Drug Administration approval by next year for its two advanced-stage drug candidates. Daily eye drops Rophressa and Roclatan are designed to lower intraocular pressure in patients with wide-angle glaucoma and ocular hypertension.
Irvine-based Aerie went public in 2013, raising net proceeds of approximately $68 million. It trades at about $58 per share for a $2.1 billion market cap.
The company resubmitted a new-drug application to the FDA in February for Rophressa and is completing two phase three trials for Roclatan. It had to withdraw the initial submission filed last September due to a contract manufacturer failing to pass the FDA’s preapproval inspection.
Meanwhile, the company plans to also seek European approval, with the idea of filing for regulatory approval for Rophressa next year. It initiated a phase three trial for Roclatan this month.
“We believe our clinical plans for both Rophressa and Roclatan are already in place to satisfy European regulatory requirements,” it said in a company statement.
Aerie has added positions in sales and marketing in anticipation of commercialization. Last month, it named Deanne Melloy vice president of marketing, Norbert Lowe regional sales director for the west region, and Dr. Isabel Moredo eastern regional director of medical science liaisons.
Moredo previously held similar leadership positions at pharmaceutical companies Lundbeck US and Johnson & Johnson. Melloy most recently served as chief commercial officer at Egalet Corp., and Lowe was responsible for U.S. refractive sales at Carl Zeiss Meditec AG.
COO
Fountain Valley-based MemorialCare Health System named Ikenna Mmeje chief operating officer of Long Beach Memorial, replacing Tamara Kaplan. Kaplan, who was chief operating officer for both Long Beach Memorial and Miller Children’s & Women Hospital Long Beach over much of the past year, now serves as chief operating officer of Miller Children’s.
John Bishop, chief executive of Long Beach Memorial and Miller Children’s, said the appointments strengthen its footprint and presence. “We have been among a very small number of hospital campuses in the U.S. with both an adult and children’s hospital,” he said.
He said the health system plans to grow its pediatric arm, including adding specialty physicians, setting up satellite facilities and outpatient centers, and expanding Miller Children’s partnership with the University of California-Los Angeles Mattel Children’s Hospital.
Mmeje was most recently chief executive of Doctors Hospital of Manteca and chief operating officer of Sierra Vista Regional Medical Center in San Luis Obispo. Kaplan had served as chief executive of Long Beach Memorial for the past nine years.
Long Beach Memorial and Miller Children’s are next to each other on a 56-acre campus, with a combined 822 inpatient beds.
Development Donation
Johnson & Johnson Vision in Santa Ana, formerly Abbott Medical Optics Inc., continues to support the Blind Children’s Learning Center under its new parent company. It gave a $10,000 check to support the center’s in-home infant development program.
Santa Ana-based Blind Children’s provides therapeutic services to children who are blind, have visual impairments, or are deaf and blind. It provides on-site and in-home programs to over 120 children—54 in its center-based program from birth to 3 years old, and 72 in its center-based program from the age of six weeks to second grade. It also works with children in the school districts.
Collen Roach, president and executive director of the nonprofit, said children with visual impairments are at severe risk of delayed development in almost all aspects of life, which is why its program stresses the importance of early intervention.
The center pairs each child with a team of specialists, including licensed occupational therapists, speech and language pathologists, physical therapists and marriage and family therapists. Infant vision stimulation specialists introduce various methods and tools to maximize a child’s vision potential.
Dental Expansion
Western Dental in Orange acquired pediatric dental services provider Kids Dental Kare in Los Angeles. The purchase was comprised of 14 locations, including offices in Huntington Park, Hollywood, East L.A., Panorama City, Lynwood, El Monte, Paramount, Norwalk, Crenshaw, Baldwin Park, Burbank, Pasadena, Oxnard and Fresno.
Bits & Pieces
Nonprofit Alzheimer’s Orange County and the University of California-Irvine’s Institute of Memory Impairments and Neurological Disorders will host a conference on Alzheimer’s and dementia care at the Irvine Marriott Hotel on Sept. 22. … Orange County’s Credit Union in Santa Ana took a Walk in the Park with Children’s Hospital of Orange County on Aug. 27, raising over $30,000. The company has until the end of this month to reach its goal of $35,000. CHOC’s goal for this year’s walk is $2.5 million.
