This Day On The Street
Continue to site right-arrow
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here
Cramer's Action Alerts PLUS - See his portfolio and get alerts BEFORE every trade. Learn more NOW!

Ampio Announces Successful Pre-IND Meeting With The Ophthalmology Division Of The FDA On Optina™ For The Treatment Of Diabetic Macular Edema

GREENWOOD VILLAGE, Colo., Aug. 1, 2012 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (Nasdaq: AMPE), a clinical stage biopharmaceutical company developing drugs for the treatment of inflammation, eye disease, kidney disease, CNS disease, metabolic disease and male sexual dysfunction today announced that a pre-IND meeting with the FDA's ophthalmology division of the Center for Drug Evaluation and Research (CDER) took place on July 31 st 2012 seeking guidance for a clinical trial path for Optina .  A summary of the meeting is as follows:


  • The meeting followed a letter from the FDA providing guidance for the path of approval of Optina in the USA.
  • The FDA agreed to Ampio's proposed indication for Optina™ as a drug for the treatment of Diabetic Macular Edema (DME) in adults.
  • The FDA agreed that the approval process through the 505(b)2 pathway is acceptable.
  • The FDA raised no safety or CMC concerns.
  • The FDA agreed that no additional non-clinical studies are necessary and that guidance for the dose and inclusion/exclusion criteria for this larger trial may be drawn from the recently completed successful Canadian trial. 
  • The proposed study, agreed by the FDA to be conducted by Ampio, will be based on similar end points as the intraocular injectable drug, Lucentis™

Dr. Vaughan Clift, Ampio's Chief Regulatory Officer, noted: "We are now able to launch a larger study using visual acuity rather than Optical Coherence Tomography (OCT) as the measure of efficacy and we are able to adjust the dosage to body mass index (BMI) to achieve the optimal benefit.  We are pleased that the injectable drug Lucentis™ is likely to be approved and made available to the underserved DME patients.  We believe Optina may provide additional advantages to these patients, as Optina™ is administered orally and is based on a very low dose of a previously approved drug, danazol.  Extensive clinical experience with the drug has allowed the FDA to permit Ampio to use the 505(b)2 path for drug registration.  The 505(b)2 is a significantly shorter and less expensive path than those of new chemical entities. There is an obvious advantage to an oral drug vs. one that requires injection directly into the eye.  Complications such as eye infection, increased intra ocular pressure (IOP) and local eye irritation reported in the Lucentis™ studies are NOT a concern for Optina ."

Michael Macaluso, Ampio's CEO, reflected on the achievement of this latest milestone, "One year ago we selected three (3) drugs from our extensive pipeline and set as our goal the advancement of each drug through carefully managed clinical paths into late stage pivotal trials that are within our means to finance, are relatively short in duration and in full compliance with FDA guidance.  These preparatory clinical trials took place in Europe (Zertane ), Australia (Ampion ) and Canada (Optina ). With this latest meeting with the FDA, we have met our interim goal.  We now have two drugs poised for pivotal trials (Zertane™ and Ampion™) and Optina™ is approved for a 505 (b) 2 pathway in the USA."

About the Canadian Clinical TrialThe Optina™ trial, conducted at St Michael Hospital in Canada, was a phase II, placebo-controlled, double-masked study to evaluate the efficacy and safety of a 12-week treatment with oral Optina™ in adult patients with Diabetic Macular Edema (DME).  Three Optina™ doses were studied and administered orally twice daily. Patients were randomized into one of the three Optina™ arms, or placebo. The primary endpoint was change from baseline to week twelve of treatment in retinal thickness as measured by Optical Coherence Tomography (OCT). Secondary endpoints were 1) change from baseline to week twelve in retinal volume and 2) change from baseline to week twelve in Early Treatment. The study results indicate a clinically meaningful reduction in edema at the appropriate dosage and a parallel improvement in visual acuity. 

About Optina Ampio is developing Optina , an orally administered low dose of danazol, for the treatment of diabetic macular edema (DME).  Ampio's Chief Scientific Officer discovered an unexpected activity in his investigation of the mechanism of action of danazol: very low doses reversed inflammation induced increases in the permeability of blood vessels, thus reducing vascular leakage.  Dr. Bar-Or subsequently managed In Vitro studies that suggested this effect may reduce the vasogenic edema produced from multiple diseases, including diabetic macular edema which can impair vision and cause blindness (Diabetic Macula Edema, DME). The specific Optina dosages are proprietary and subject to multiple patent filings.

Danazol, a derivative of the synthetic steroid ethisterone, was approved by the FDA in the 1970s for endometriosis and, more recently, for other chronic indications, including hereditary angioedema.

1 of 2

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Try it NOW
Only $9.95
Try it NOW
14-Days Free
Try it NOW

Check Out Our Best Services for Investors

Dividend Stock Advisor

David Peltier identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Options Profits

Our options trading pros provide over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • Actionable options commentary and news
  • Real-time trading community
Try it NOW
Try it NOW
Try it NOW
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!


DOW 17,776.12 -200.19 -1.11%
S&P 500 2,067.89 -18.35 -0.88%
NASDAQ 4,900.8850 -46.5560 -0.94%

Partners Compare Online Brokers

Free Reports

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs