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New therapies target dry eye, conjunctivitis, redness, presbyopia
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WASHINGTON – Paul M. Karpecki, OD, FAAO, reported on new and up-and-coming ocular therapeutics at a continuing education session here at Optometry’s Meeting.
Allergan received FDA approval in April to market TrueTear intranasal tear neurostimulator.
“Meibomian glands make up for lacrimal gland function, but they overwork and burn out,” Karpecki said.
If you hit the nasal branch of the trigeminal nerve, you can stimulate the nerve and, in turn, stimulate the meibum and aqueous, he said.
TrueTear is “one more option to go with artificial tears,” Karpecki said.
“It doesn’t mean you still don’t have to treat the obstruction and inflammation,” he added.
“Neurostimulation is not that new,” Karpecki noted. “Pacemakers, epilepsy treatment, Parkinson’s’ treatment, seizure disorders are all related to neural stimulation. This one focuses on the trigeminal neve, which is in the middle of our world.”
Karpecki discussed a treatment under study for conjunctivitis.
Some practitioners use povidone-iodine with great success for adenoviral conjunctivitis, but the treatment is uncomfortable for patients, he said.
SHP640, PVP-iodine 0.6% and dexamethasone 0.1% from Shire, is in phase 3 clinical trials for treatment of adenoviral and bacterial conjunctivitis.
The trial will include four multicenter, double-masked, placebo-controlled studies: two for adenoviral conjunctivitis and two for bacterial conjunctivitis, according to a press release from Shire.
Bob Dempsey, Shire vice president and head of global ophthalmics, in a separate interview told Primary Care Optometry News that 40 sites are enrolling more than 2,700 patients for the study.
The AdenoPlus (Quidel) test is performed on the subjects, he explained. If the test is positive, the patient is placed in the adenoviral arm; if it is negative; they are placed in the bacterial arm. Then each of those arms has a treatment and a placebo group.
The drug is administered one drop in each eye four times a day for 7 days, according to clnicaltrials.gov. Outcome measures include hyperemia, ocular discharge and cell culture immunofluorescence assay results.
Dempsey said patient symptom endpoints are pain and discomfort.
He said the dexamethasone helps break down the integrity of the cell wall and allows the povidone iodine to penetrate.
Luminesse (brimonidine tartrate ophthalmic solution 0.025%), from Bausch + Lomb, has been studied in six clinical trials to evaluate its safety and efficacy in relieving ocular redness, including a study to demonstrate the absence of IOP-lowering potential of low-dose brimonidine, according to a press release from the company.
The company announced in May that the FDA accepted its New Drug Application and set a PDUFA action date of Dec. 27, 2017.
Karpecki said that the drop whitens 300% more than Visine (tetrahydrozoline HCl 0.05%, Johnson & Johnson Consumer), lasts 4 to 8 hours and has no rebound hyperemia.
He also discussed a topical treatment for presbyopia under study.
“Imagine putting a drop in at age 40 and never having to need any surgery,” Karpecki said.
EV06 ophthalmic solution (lipoic acid choline ester, 1.5%; Encore Vision/Novartis) is in phase 2 studies, he said, with four-times-a-day dosing.
“In the young eye, cytosol displacement allows accommodation,” Karpecki said. “In the aging eye, this doesn’t happen.
“EV06, lipoic acid choline ester, is like a super antioxidant,” he continued. “It breaks down bonds. Patients were able to regain elasticity. There were no adverse events, no patient complaints, no change in best corrected distance acuity. It happened fast. The average patient went from seeing 20/50 near to 20/20 and 20/25 up close in 3 months. It’s also been shown that this can reverse cataracts.” – by Nancy Hemphill, ELS, FAAO
Reference:
Karpecki P. In the pipeline: Thinking outside the box – What’s new in optometry, parts 1 and 2. Presented at Optometry’s Meeting; Washington; June 21-25, 2017.
Disclosure: Karpecki receives consulting fees from AcuFocus, Aerie Pharmaceuticals, Anthem, AMO, Alcon Labs, Allergan, Akorn, Bausch + Lomb/Valeant, BioTissue, Bruder Healthcare, Cambium Pharmaceuticals, Eyemaginations, Essilor, Eyes4Lives, Eye Solutions, Focus Laboratories, iCare USA, Johnson & Johnson Vision Care, OcuSoft, Freedom Meditech, Konan Medical, MacuLogix, Beaver-Visitech, Ocular Therapeutix, Reichert, Shire Pharmaceuticals, Regeneron, RySurg, ScienceBased Health, SightRisk, TearLab, TearScience, TLC Vision, Topcon and Vmax. He is on the speakers’ bureau for Glaukos and Oculus; has conducted research for Akorn, Allergan, Bausch + Lomb, Eleven Biotherapeutics, Fera Pharmaceuticals, Rigel Pharma and Shire; and has an ownership interest in Bruder HealthCare and TearLab.