Spotlight

Building a better omega-3

PRN’s oral supplement is “re-esterified” to help treat DED

By Robert Stoneback, associate editor

Michael Gross, MD, FACOG, didn’t realize he’d created a dry eye treatment 10 years ago.

A physician with a background in obstetrics and clinical nutrition, he developed an omega-3 nutriceutical in 2006 called Flex Omega Benefits to improve joint health and act as an anti-inflammatory agent. Later that year, Frank Bucci, MD, of Wilkes-Barre, Pa.’s Bucci Laser Vision Institute, contacted him to say his nutriceutical was the best post-LASIK treatment for dry eye he had ever used. Dr. Gross had one question ­— what’s dry eye?

Dr. Gross doesn’t ask that question anymore. At Physician Recommended Nutriceuticals, he is its executive vice president and chief medical officer.

PRN has added several other products to its catalog over time, including Dry Eye Omega Benefits, designed in the years since Dr. Gross and Dr. Bucci had their conversation.

TESTED AND PROVEN

Dry Eye Omega Benefits, made from the omega-3s eicosapentaenoic acid and docosahexaenoic acid (EPA and DHA) and in a cleaned triglyceride form (rTG), has been the subject of a study in September’s Cornea. This study involved 105 subjects, and its researchers wanted to see if oral consumption of the re-esterified omega-3 fatty acids would achieve primary endpoints associated with DED. Over the 12-week test time, the 54 subjects who received PRN’s Dry Eye Omega Benefits experienced a statistically significant improvement in tear osmolarity, tear break-up time (TBUT) and ocular surface disease Index scores along with an increase in omega-3 index levels and reduction in MMP-9 positivity.

When measuring tear osmolarity, the mean mOsm in the experimental group was 326 at baseline and by week 12, it had dropped to 306, a 19.4 mOsm reduction. In contrast, the control group did not show a statistically significant reduction and remained abnormally high. (For additional data from the study, please see the table on page 68.)

The results of the study were impressive, says lead investigator Alice Epitropoulos, MD.

“No other dry eye option has ever collectively achieved these kind of benchmarks.”

THE RE-ESTERIFICATION PROCESS

Dr. Epitropoulos has seen many dry eye patients who were resistant to more traditional therapies but had their symptoms significantly improve after adding a quality omega-3 regimen to their diet. Dry Eye Omega Benefits falls into this category due to its “re-esterification process,” she says.

After fish oils are extracted, alcohol is typically added to detoxify them, but the alcohol changes the oil’s natural triglycerides into an ethyl ester compound. Humans have difficulty processing this artificial compound.

The re-esterification process, though, removes the alcohol after it’s used to clean the oil to return it “back to nature’s form,” says Dr. Gross. Re-esterification is one key to the effectiveness of Dry Eye Omega Benefits, he continues. Many other physician-recommended omega-3 products don’t go through this process, and therefore result in insufficient absorption, bioavailability and therapeutic value. “[Patients] could take car loads of those things and get no benefit.”

“There’s a big difference between ethyl ester and re-esterified [omega-3s],” adds Dr. Epitropoulos. With Dry Eye Omega Benefits, “Pretty much 100% [of the oil’s omega-3s] gets into the system,” compared to about one third of the omega-3 from ethyl ester fish oil pills.

NUTRICEUTICAL VS. SUPPLEMENT

Dr. Gross emphasizes that Dry Eye Omega Benefits is not a “supplement,” like many other omega-3 products recommended by physicians or available for retail purchase. As a nutriceutical, Dry Eye Omega Benefits has gone through much more rigorous testing and research than most fish oil supplements, he says, and re-esterification is one of these key differences.

PRN sells its products, including Dry Eye Omega Benefits, exclusively through doctors instead of on the retail market, in part because it doesn’t want to be confused or compared with supplements, says Dr. Gross.

Further proof of PRN’s high standards, continues Dr. Gross, are the two patents it has been awarded for Dry Eye Omega Benefits. A composition patent for the formula was issued in November 2015, and a method (mechanism of action) patent was released this past July. These patents provide a strong base of evidence for PRN’s treatment and are a source of pride for the company, says Dr. Gross.

“This is something that should be considered for every patient with dry eye disease,” continues Dr. Gross.

While it takes about two to three months for the average patient to achieve optimal results with Dry Eye Omega Benefits, it offers a long-term solution as it adds essential nutrients into the diet, Dr. Gross says.

Dr. Epitropoulos agrees.

“We’re quickly coming to realize that oral nutrition is a primary therapy for dry eye disease and MGD [meibomian gland disease].” OM

PRN’s Dry Eye Omega Benefits uses a re-esterification process to increase its effectiveness.

Alice Epitropoulos, MD, is a consultant and speaker for PRN.