Studies probe link between antioxidants, ocular health

Antioxidants may hold the key to reducing cases of cataracts, AMD.

By Robert Stoneback, associate editor

Studies have been amassing links between antioxidants and eye health. One example examines cataract development in twins, and two others concern the Mediterranean diet’s effects on cataracts and AMD. The common denominator among them all: the more antioxidants consumed, the lower the risk of the ocular disease or disorder.

For Stuart Richer, OD, PhD, FAAO and president of the Ocular Nutrition Society, this “is not surprising.” One of the most notable antioxidants is vitamin C, which “is actively accumulated in all of the individual tissues of the human eye, including the lens, for growth and repair.”

The Mediterranean diet

One study, presented at the 2016 AAO meeting, showed that an antioxidant-rich Mediterranean diet, which includes foods such as fruits, vegetables, olive oil and seafood, can reduce the risk of AMD by one-third.¹ Research was conducted in Portugal among 883 people age 55 and older. Findings included:

• Among the group that most closely followed the diet, only 39% had AMD; of the group that did not follow it closely 50% had AMD.
• Patients who consumed at least five ounces of fruit a day were 15% less likely to have AMD compared to those who did not eat that much fruit.
• Caffeine was protective against AMD; of those who consumed about 78 mg a day, or the equivalent of an espresso shot, 54.4% did not have AMD.

A 2013 study, conducted in Spain and published in BMC Ophthalmology, included 599 people over the age of 65, 433 of whom had cataracts or cataract extractions. Increased intake of fruits and vegetables high in antioxidant vitamins was associated with a decreased chance of cataracts, with the odds reduced even further with a higher intake. The greatest benefit was seen among those who ate between 143 mg and 408 mg of fruits and vegetables a day; they saw a 54% reduced chance of cataract formation.²

Twins, vitamin C and cataracts

In a study of 1,000 female British twins, published online last year in Ophthalmology, those who consumed a diet rich in vitamin C had a 33% risk reduction for cataract progression. In total, environmental factors such as diet accounted for 65% of the cataract risk reduction. Genetic factors accounted for the remaining 35%. Data were collected from patients who filled out a food questionnaire.

In the prospective arm of the study, cataracts were first measured when the patients were around age 60, with follow-up measurements taken 10 years later on 324 of the available twin pairs.

The researchers theorized that the eye’s aqueous humor, naturally high in vitamin C, helps prevent the oxidation that clouds the lens; therefore consuming more vitamin C may increase the amount found in the aqueous humor. A vitamin C rich diet may delay cataract onset and keep them from worsening, note the study authors.³

Another theory

Lisa B. Arbisser, MD, who serves as an adjunct professor of ophthalmology at the University of Utah Moran Eye Center, doesn’t dispute the value of a healthy diet. However, in addressing the twins study, which only found a benefit when patients ate antioxidant foods and not by taking supplements, “the bottom line may be that vitamin C deficiency is associated with cataract development. But a surplus — which is hard to achieve anyway as [vitamin C] is water soluble and not stored — has no proven effect even in the carefully studied AREDS 2 trial. Therefore, I haven’t recommended supplementation,” says Dr. Arbisser.

“Eating these vitamins C-rich foods like citrus must be a perennial routine,” she adds.

However, Dr. Richer says the twins study did not have sufficient power to determine if vitamin C supplements conferred the same benefits as foods.

Shop the rim

Plant food, the major source of vitamin C, is in short supply in the “standard American diet” that is high in calories and low in micronutrients, says Dr. Richer. “Food often supplies glutathione and precursor molecules, as well as vitamin E and polyphenols that support the desirable redox status of vitamin C. High-quality plant food helps repair and maintain lenticular tissue and protects against toxins found in cigarette smoke, excess sugar and free radicals induced by ultraviolet A radiation reaching the lens.”

Consumption of high-quality plant food is even more crucial in an aging population, when endogenous antioxidant production and cellular mitochondrial function begin to dwindle. OM

REFERENCES

1. Fruit-rich Mediterranean diet with antioxidants may cut AMD risk by more than a third. Amer Acad Ophthalmol. http://tinyurl.com/jh6gvwu . Accessed February 10, 2017.
2. Pastor-Valero M. Fruit and vegetable intake and vitamins C and E are associated with a reduced prevalence of cataract in a Spanish Mediterranean population. BMC Ophthalmol. 2013;13:52.
3. Eating foods high in vitamin C cuts risk of cataract progression by a third. Amer Acad Ophthalmol. http://tinyurl.com/gn3dd3g . Accessed February 10, 2017.

Ocular Therapeutix expects word in July on Dextenza

Studies show the insert offers improved pain treatment.

By Robert Stoneback, associate editor

This July, Ocular Therapeutix will know if the FDA has approved its intracanalicular insert to treat postsurgical eye pain. It received word in late February that the agency would review its new application.

The company resubmitted its New Drug Application (NDA) in January for Dextenza (dexamethasone insert) 0.4 mg. The Dextenza insert is placed through the lacrimal punctum after surgery, where it remains in the eye’s canaliculus. It releases dexamethasone to the ocular surface for up to 30 days after surgery; the patient avoids the need to administer eye drops. The insert does not need to be removed afterward, as it resorbs on its own.

If approved, Dextenza will be the first insert on the market to treat postsurgical pain. Other, non-insert pain medications are currently available from manufacturers such as Alcon and Bausch + Lomb.

In accepting the NDA, the FDA announced that Dextenza had been designated for a Class 2 review. Under the Prescription Drug User Free act, this allows the FDA to take up to six months to decide on the application.

“We are pleased the FDA has accepted our resubmission of the Dextenza NDA,” said Amar Sawhney, PhD, president, CEO and chairman of Ocular Therapeutix, via a press release.

“If approved, we believe Dextenza will be the first non-invasive therapy available to patients and ophthalmologists that can provide a full post-operative course of therapy with a single placement.”

Ocular Therapeutix conducted three clinical trials to test its product. All three hit endpoints for pain. During the second trial, Dextenza missed its endpoint for inflammation, but made that endpoint during the first and third trials.

Dextenza’s resubmission to the FDA did not include the data related to inflammation, as that would have delayed Dextenza’s market release by several months, according to Jonathan Talamo, MD, chief medical officer for Ocular Therapeutix.

“If the FDA approves us for post-operative pain, we plan to promptly file an NDA supplement for the inflammation indication” for Dextenza, says Dr. Talamo.

Ocular Therapeutix received a complete response letter (CRL) from the FDA in July 2016. There were no clinical issues identified with Dextenza, according to Dr. Talamo. Rather, the CRL had to do with manufacturing deficiencies noted following the FDA’s facility inspection.

According to Dr. Talamo, the deficiencies included the testing process for an inert gas used in manufacturing.

In November, Ocular Therapeutix announced results of a phase 3 clinical trial to evaluate Dextenza’s safety and efficacy in postoperative ocular inflammation and pain. The trial compared results in 438 cataract patients.

Patients were randomized into either a Dextenza group or a placebo group. Of the 216 patients who received the Dextenza insert, 79.6% reported absence of pain by day 8, compared to 61.3% of those with the placebo.

During the inflammation test for Dextenza’s third, phase 3 trial, 52.3% of the Dextenza patients showed an absence of inflammatory cells in the anterior chamber by day 14, compared to 31.1% in the placebo group.

The resubmission included a letter from the FDA’s local district office indicating that the company had satisfactorily addressed manufacturing deficiencies noted during a previous facility inspection.

In addition, the resubmission provided information pertaining to recently completed commercial manufacturing lots.

Once the FDA district office provided that letter, Ocular Therapeutix resubmitted the NDA. OM

Online group forms to enhance business of eye care

Resources provided include forums, leadership training and financing information.

Jennifer Kirby, PentaVision editor

Eye Care Leaders, now 2 years old, is a technology- and services-solution company designed to help the ophthalmic community with its business practices, whether it is getting the most out of an EHR or managing revenue cycles.

It recently started a new venture because, the company says, it has recognized a new need: eye-care professionals need a place to talk about the industry’s challenges, to learn from their thought leaders and to exchange ideas. Eye Care Visionaries (eyecarevisionaries.com ) welcomes ophthalmologists, optometrists and practice managers into the conversation.

“We encourage like-minded eye-care leaders seeking to grow personally and professionally to join this new industry initiative and peer network dedicated to furthering the eye-care profession through insights, tools and innovation,” explains Jennifer Godreau, CPC, Eye Care Leaders’ vice president for Programs.

Specifically, Eye Care Visionaries provides members with online forums, leadership training and development, software, consulting and capital financing information and operational templates, whitepapers and on-demand webinars on topics such as revenue cycle solutions, practice marketing and patient acquisition and retention, says the company. Further, the group affords insights from its Advisory Board Industry Leaders, which includes Michael X. Repka, MD, vice chair of Clinical Practice at the Wilmer Eye Institute at Johns Hopkins.

To become a member of Eye Care Visionaries, sign up on the website, free of charge. From there, the applicant is placed in one of two camps: Luminaries or Receptors. Those in the Luminaries group are seasoned professionals who are dedicated to furthering the eye-care industry, Eye Care Leaders says. Those in the Receptors group are highly motivated to achieving success via the implementation of new strategies, the company says.

Live events are exclusive benefits reserved for Luminaries, who may receive invitations to speak and contribute content. OM

EYE ON THE ODD
“Dr. Horus will see you now”

The civilization of the ancient Egyptians was ahead of its time in many ways, but its view on eye care was very different from what we know today. According to the paper “The eye and its diseases in Ancient Egypt,” by S. Ry Andersen and published by the Acta Ophthalmologica Scandinavica, the ancient Egyptians had records of many different eye diseases. Translations by more modern scholars have found references to hemorrhages in the eyes, inflammation and corneal scars or leukoma.

Eye drops were used rarely, with ointments being the most common topical treatment. A common ingredient in these ointments was honey, partly because it was believed to ward off demons. The Egyptians had 18 different “magical” ointments they believed helped protect against such beings. In addition, magic spells were regularly invoked during the topical treatment of eye diseases, which usually included a plea to the Egyptian god Horus. One such invocation: “Welcome, thou splendid eye of Horus, to combat the threat from a god or goddess … to the eyes of this man. Protection behind (me), protection, (here comes) protection!”

“The Egyptian art of medicine consisted in selecting the right drugs, preparing them in a magically correct way and speaking the appropriate words over them,” according to Mr. Andersen.

Amulets created to resemble Horus’ eye were often used as protective charms by Egyptians and were thought to ward off eye disease.

Maria Rosa, of the University of Buenos Aires, further examines Horus’ connection to eyesight in a paper for Acta Medico-Historica Adriatica. One of Horus’ eye was said to represent moonlight, which disperses the darkness of the night, and the other represented sunlight, which creates life. Blindness – the inability to perceive the world – was seen as a form of divine punishment.

While it is difficult to determine the actual medicinal effects for many of the ancient Egyptians’ cures, the psychological placebo effect may have been one of the greatest benefits, writes Mr. Andersen.