hr Pharmaceutical, Inc.
OHRP, an ophthalmology research and development company, today
announced the company has submitted a Special Protocol Assessment (SPA)
request to the U.S. Food and Drug Administration (FDA or agency), as part of
the ongoing interaction with the FDA on the detailed design of the Phase 3
clinical development program of OHR-102 (Squalamine Lactate Ophthalmic
Solution, 0.2%) for the treatment of neovascular Age-Related Macular
Degeneration (wet AMD).
The SPA request includes a detailed protocol that was designed based on
previous guidance the company received from the agency, to address and
adequately provide the agency with a Phase 3 program that produces data that
would allow assessment of efficacy and safety of OHR-102 for the treatment
of patients with wet AMD. The FDA may take up to 45 calendar days to provide
comments to Ohr Pharmaceutical.
"We have submitted an SPA request to the FDA with the goal of solidifying
the development and regulatory pathway for OHR-102, and specifically, the
details of our planned Phase 3 clinical trials," said Jason Slakter, M.D.,
Chief Executive Officer of Ohr. "OHR-102 may offer wet AMD patients a
convenient, topical approach that produces clinically meaningful
improvements in vision beyond that achieved with anti-VEGF injections alone,
and we are excited to be moving the program into Phase 3 development."
The planned Phase 3 clinical trials are designed as well-controlled,
double-masked, placebo-controlled, multicenter, international studies of
OHR-102 administered twice a day in patients with newly diagnosed wet AMD,
in combination with Lucentis(R) injections. The company expects to initiate
the Phase 3 program in late 2015 and enroll the first patients by year-end
2015 or in the first calendar quarter of 2016.
Presentation at the Annual American Academy of Ophthalmology Meeting
The company will be presenting additional detailed data from the recently
completed Phase II IMPACT study during the retina subspecialty meeting at
the American Academy of Ophthalmology annual meeting, taking place from
November 13-17, 2015, in Las Vegas, NV. The podium presentation will be
given by Dr. David S. Boyer, retina specialist at Retina-Vitreous Associates
Medical Group, Beverly Hills, and investigator in the IMPACT study. Details
of the presentation are as follows:
Title: Squalamine Eye Drops in Retinal Vascular Diseases
Speaker: Dr. David S. Boyer
Location: Sands Expo/Venetian
Time: Friday, November 13, 2015, 3:43pm PST
About a Special Protocol Assessment (SPA)
A Special Protocol Assessment (SPA) from the FDA is a binding agreement that
the design and planned analysis of a study adequately address the objectives
necessary to support a regulatory submission. More information about the
FDA's Special Protocol Assessment process is available at
http://www.fda.gov/downloads/Drugs/.../Guidances/ucm080571.pdf.
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