GREENWOOD VILLAGE, Colo. (TheStreet) -- Ampio Pharmaceuticals' (AMPE) "phase III" clinical trial of the low-dose steroid Optina in diabetic macular edema finally showed on the ClinicalTrials.gov registry maintained by the U.S. Food and Drug Administration, one month after the company announced treatment of the first patient.
Why the delay? Ampio blames the grinding gears of government for the late registration. The more likely reason, in my book, is that Ampio waited as long as possible before disclosing the glaring design flaws and unrealistic expectations for the Optina study.
Ampio is telling investors that positive results from the Optina study could lead to an approval filing for the drug as a new treatment for diabetic macular edema. That's total nonsense. The efficacy and safety data to be collected from this study falls far short of what FDA would require for approval. At best, Ampio is conducting a phase II study of Optina, to call it a phase III study or a pivotal, registration-quality study is totally misleading.
Diabetic macular edema is a swelling in the central portion of the retina caused by damaged or leaky blood vessels. If untreated, DME can lead to vision loss and blindness. The Ampio study intends to enroll 450 DME patients and randomize them to treatment with Optina (a low-dose reformulation of the generic oral steroid danazol) or a placebo for 12 weeks. The study's primary efficacy endpoint is improvement in vision, measured by the Best Corrected Visual Acuity (BCVA) test.The FDA has never approved a DME drug based on efficacy from a 12-week clinical trial. Roche's (RHHBY) eye drug Lucentis was approved as a treatment for DME in August 2012 based on two phase III studies that measured vision improvement using the BCVA test over two years. The studies included an additional year of patient follow up. Regeneron Pharmaceuticals (REGN) is seeking to expand the approval of its eye drug Eylea to allow for the treatment of DME patients. Phase III studies currently underway also measure vision improvement for two years. Alimera Sciences (ALIM) also ran two-year studies for its DME drug Iluvien, which like Optina, is a steroid.
Select the service that is right for you!COMPARE ALL SERVICES
Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Upgrade/downgrade alerts
Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.
- Real Money + Doug Kass + 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV