For years many eyeMDs were very suspicious of the effect of Azasite on improving dry eye symptoms and meibomian gland dysfunction primarily because the first studies were sponsored by the drug company and the drop was very expensive (ridiculously so).
A paper below #2, though, says it was not sponsored by the company which shows Azasite’s promise in helping with MGD and DED. I have had 4 patients note that it helped them. I also had a patient come in from another eyeMD who noted it made them much worse with pain and severe redness: mostly likely a severe allergy.
Paper #1 below about a similarly working drop called Solithromycin was evaluated by the same research group at Harvard and it was sponsored by the company.
So does it really work or not? Is it worth the money?
I do not see any studies on real patients not sponsored by the drug company to say it does work and it is worth the cost. The risks are low though.
What has been your experience with Azasite? Let me know. How much did it cost you?
Let me know.
Sandra Lora Cremers, MD, FACS
Paper 1:
Declaration of interests
This study was sponsored by Cempra Pharmaceuticals.
Paper 2:
Can Tetracycline Antibiotics Duplicate the Ability of Azithromycin to Stimulate Human Meibomian Gland Epithelial Cell Differentiation?
Liu, Yang MD; Kam, Wendy R. MS; Ding, Juan PhD; Sullivan, David A. PhD
Schepens Eye Research Institute, Massachusetts Eye and Ear Infirmary, and Harvard Medical School, Boston, MA.
Reprints: Yang Liu, MD, Schepens Eye Research Institute, 20 Staniford St, Boston, MA 02114 (e-mail:yang_liu@meei.harvard.edu).
Supported by NIH grant EY05612, the Margaret S. Sinon Scholar in Ocular Surface Research Fund, and the Guoxing Yao Research Fund.
The authors have no conflicts of interest to disclose.
Yang Liu had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analyses.
A provisional patent has been filed around this technology. Intellectual property for this application is owned by the Schepens Eye Research Institute/Massachusetts Eye and Ear.
Received September 12, 2014
Received in revised form October 09, 2014
Accepted November 14, 2014
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Meibomian gland dysfunction (MGD), the leading cause of dry eye disease throughout the world, afflicts hundreds of millions of people and has no cure.1,2 In the United States, antibiotics such as azithromycin and tetracyclines—especially doxycycline, minocycline, and tetracycline—are widely used off-label in the treatment of MGD.1 Therapeutic effects of these antibiotics were believed to be indirect, suppressing MGD-associated posterior blepharitis and bacterial lipase activity on the lid.2
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However, we recently discovered that azithromycin can act directly on human meibomian gland epithelial cells (HMGECs) to induce cholesterol, phospholipid, and lysosome accumulation, and ultimately a holocrine-like secretion.3,4 We hypothesize that this intracellular effect of azithromycin is due in large part to its cationic amphiphilic structure.5 If our hypothesis is correct, then azithromycin’s action on HMGECs is unique, and will not be duplicated by tetracyclines. To test this hypothesis, we compared the effects of azithromycin and tetracyclines on HMGEC differentiation and proliferation in defined conditions.6,7 We also determined the relative ability of these antibiotics to induce sterol regulatory element–binding protein 1 (SREBP-1) and cyclin B1, which are key regulators of lipogenesis and the cell cycle, respectively.8,9
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This study was sponsored by Cempra Pharmaceuticals.
Curr Eye Res. 2017 Dec 28:1-6. doi: 10.1080/02713683.2017.1418894. [Epub ahead of print]
The Effect of Solithromycin, a Cationic Amphiphilic Drug, on the Proliferation and Differentiation of Human Meibomian Gland Epithelial Cells.
Author information
- 1
- a Schepens Eye Research Institute, Massachusetts Eye and Ear, and Department of Ophthalmology , Harvard Medical School , Boston , MA , USA.
- 2
- b Cempra Pharmaceuticals , Chapel Hill , NC , USA.
Abstract
PURPOSE:
MATERIALS AND METHODS:
RESULTS:
CONCLUSIONS:
More info about the Company:
The pharmaceutical company received an FDA rejection of the worst kind.
IMAGE SOURCE: GETTY IMAGES.
What happened
Cempra (NASDAQ:CEMP) is down 56% at 12:17 p.m. EST Thursday after announcing that the Food and Drug Administration had issued a complete response letter — the agency’s euphemism for a rejection letter — for the biotech’s antibiotic solithromycin.
So what
The rejection wasn’t unexpected since Cempra had already disclosed that the FDA had discovered issues with the company’s contract manufacturer for the drug that needed to be resolved before the drug could be approved. Cempra had already put a backup plan in motion, working with another contract manufacturer in case its current one couldn’t resolve the issue quickly. There also appears to be an issue with Cempra’s manufacturer for the injectable version of the drug, although the FDA didn’t disclose the details.
More importantly, the rejection letter also noted that “additional clinical safety information” would be required before the agency would approve solithromycin. The FDA had previously disclosed that patients treated with the drug had signs of liver toxicity, so the problem was known, but investors were hoping that the FDA would overlook the issue given the need for new antibiotics to treat bacteria that have become resistant to older antibiotics. A committee of outside experts voted narrowly — 7 to 6 — recommending the drug should be approved because the risk of death from the infection trumped the risk of liver toxicity.
The FDA didn’t see it that way. Or more specifically, the agency decided it didn’t really know how bad the liver toxicity risk was since only 920 patients received the drug at the proposed dose in the clinical trials, so the reviewers couldn’t make an informed decision about the relative risks. To alleviate the worry, the FDA suggested Cempra run a trial with 9,000 patients treated with solithromycin, as well as a group of a to-be-determined number of patients treated with another antibiotic as a control to determine the rate of serious events of drug-induced liver injury.
Now what
Cempra needs to sit down with the FDA to work out the details of the new trial, so the exact timing — and even a decision about whether to run the trial — is still up in the air, but acting CEO David Zaccardelli noted on the call that the company doesn’t expect an approval prior to 2018.
Beyond an approval for solithromycin in the U.S., Cempra has a few other options. Solithromycin is under review by European regulators, who have sometimes not seen eye to eye with their U.S. counterparts, although most of their differences seem to be about efficacy, not safety issues. Cempra is also testing solithromycin as a treatment for gonorrhea, which has a different dosing regimen that might alleviate regulators’ fears about liver toxicity. And Cempra has another antibiotic, Taksta, which is set to read out results from a phase 3 trial in the first quarter of 2017.
Cempra looks cheap at this knocked-down price, but until management discloses more details about the cost and timing of the new safety trial for solithromycin and how the liver issues might affect the gonorrhea program, it’s hard to determine the biotech’s true value.