62 GLAUCOMA TODAY | MAY/JUNE 2017

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ISARNA PRESENTS POSITIVE CLINICAL DATA FOR ISTH0036

FDA Accepts NDA Submission for Rhopressa

Aerie Pharmaceuticals received notification that the FDA has completed its initial 60-day review of the Rhopressa (netarsudil ophthalmic solution) 0.02% new drug application and determined that the application is sufficiently complete to permit a substantive review, according to a press release.

The Prescription Drug User Fee Act goal date for the completion of the FDA’s review is set for February 28, 2018. This date reflects a standard 12-month review period and is consistent with Aerie’s expectations.

The notification also indicated that the FDA has not identified any potential review issues and that it is currently planning to hold an advisory committee.

Rhopressa is a novel eye drop that, if approved, would become the only once-daily product available that specifi-cally targets the trabecular meshwork, according to Aerie.

Preclinical and clinical studies have also demonstrated that Rhopressa lowers episcleral venous pressure, and it may provide an additional mechanism that reduces fluid produc-tion in the eye and therefore lowers IOP.

Biochemically, the active ingredient in Rhopressa, netar-sudil, has been shown in Aerie studies to inhibit both Rho kinase and norepinephrine transporter.

Recent preclinical studies have also shown that Rhopressa may have disease-modifying properties, including an anti-fibrotic effect of netarsudil on trabecular meshwork cells and the potential to increase perfusion of the trabecular meshwork.

Isarna Therapeutics presented the phase 1 safety and efficacy data for ISTH0036, a locked nucleic acid-modified antisense oligonucleotide, in patients with advanced-stage glaucoma. Overall, the treatment was safe and well tolerated at all dose levels, and the post-operative IOP course provided preliminary evidence for a beneficial effect of ISTH0036 at the two highest dose levels, according to a press release.

Separately, Isarna provided positive preclinical results in a poster presentation demonstrating ISTH0036’s potential as novel therapeutic intervention in a murine model of choroidal neovascularization, supporting clin-ical exploration for indications such as wet age-related macular degeneration and diabetic macular edema.

The purpose of the first-in-human phase 1 trial, conducted at the ophthalmology departments of the University Hospitals of Mainz, Tuebingen, and Magdeburg, Germany, was to evaluate the safety, toler-ability, and preliminary clinical efficacy of intravitreal injections of ISTH0036 in patients with advanced primary open-angle glaucoma undergoing filtration surgery (trabeculectomy) with mitomycin C to address uncontrolled elevated IOP.

Glaucoma patients scheduled for filtration surgery received a single intravitreal injection of ISTH0036 at the end of trabeculectomy in escalating total doses of 6.75 μg, 22.5 μg, 67.5 μg, or 225 μg, resulting in

calculated intraocular ISTH0036 concentrations in the vitreous humor of 0.3 μM, 1 μM, 3 μM, or 10 μM, respectively, after injection. Administration of all dose levels was completed safely, and no treatment-emer-gent adverse events were considered to be related to ISTH0036 or the intravitreal injection.

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Massachusetts Considers Allowing Optometrists to Treat Glaucoma

A provision in the Massachusetts’ state budget would permit optometrists to treat glaucoma and prescribe oral medica-tions for eye infections, according to US News & World Report. Massachusetts is the only state that mandates that glaucoma patients must visit an ophthalmologist for these services. At press time, the budget had not yet been passed.

Glaukos Acquires IOP Sensor System From Dose Medical

Glaukos acquired the IOP sensor system assets and related liabilities from Dose Medical for $5.5 million in cash, plus performance-based consideration of up to $9.5 million upon achievement of certain development, clinical, and regulatory milestones, according to a press release.

The Dose Medical IOP sensor system features a micro-invasive ocular implant that is designed to capture and store a glaucoma patient’s short-interval IOP measurements over extended periods of time and transmit data to the patient’s physician in order to enhance treatment decisions. The wireless system, which is designed for ab interno insertion, incorporates a rechargeable battery that may allow the sensor to function for multiple years.

“Although still in an early development phase, the system offers future promise as a 24/7 tool for measuring the effects of glaucoma medical and surgical interventions, monitoring patient therapeutic compliance, and managing disease progres-sion,” Thomas Burns, Glaukos’ president and chief executive officer, said in a company news release.

Dose Medical was previously a wholly owned subsidiary of Glaukos. In 2010, it was spun out as a standalone entity separate from Glaukos’ go-forward business. In 2015, Glaukos acquired the iDose product line and related assets from Dose Medical. Two Glaukos directors also serve on the board of Dose Medical. The terms of the transaction were approved by a special committee consisting only of independent members of Glaukos’ board of directors.

In Remembrance: Prof. Peter WatsonProf. Peter Watson, a clinician-

scientist who was recognized internationally for his world-leading research, passed away in February. He and John Cairns, MD, revolu-tionized the practice of ophthal-mology with their invention of tra-beculectomy for the surgical treat-ment of glaucoma. Prof. Watson's

textbook on scleritis redefined the field and became the standard reference.

In remembrances, he was described as an excellent teacher, a great friend, a mentor, and one of the giants on whose shoul-ders ophthalmologists are standing.

Health Canada Approves Visco360 for Standalone MIGS

Health Canada approved the Visco360 Viscosurgical System (Sight Sciences) for the microcatheterization and transluminal viscodilation of Schlemm canal to reduce IOP in adult patients with open-angle glaucoma, according to a press release.

The Visco360 System is a fully integrated, single-handed, single-use device that offers a single-incision, 360° canal pro-cedure. The system combines a custom-access cannula; a soft and flexible microcatheter with an atraumatic tip; an internal infusion pump, gear mechanism, and viscoelastic reservoir; and a wheel that controls advancement and retraction of the microcatheter using a single finger.

Imprimis Launches Simple Drops Combination Glaucoma Drops

Imprimis Pharmaceuticals announced the launch of its new patent-pending Simple Drops preservative-free glaucoma drops. Simple Drops preservative-free drops conveniently pro-vide multiple glaucoma medications in a single bottle. n

Clearing the Record In its March/April 2017 edition, GT misidentified the manu-

facturer of the Xen Glaucoma Treatment System. The manu-facturer is Allergan.

MARCH/APRIL 2017 | GLAUCOMA TODAY 63

Stay up to date with thenews while it happens at

www.eyewiretoday.com and watch our weekly broadcast at eyewiretoday.com/tv.

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2017June 20 to July 1 Helsinki, Finland7th World Glaucoma Congresswww.worldglaucomacongress.org

September 25 to 26London19th International Conference on Glaucoma Surgerybit.ly/glaucomasurgery

November 11 to 14New OrleansAmerican Academy of Ophthalmology Annual Meetingwww.aao.org/annual-meeting

2018February 8 to 10 San FranciscoGlaucoma 360www.glaucoma.org

March 1 to 4 New YorkAmerican Glaucoma Society Annual Meetingwww.americanglaucomasociety.net

May 3 to 7San DiegoAmerican Society of Cataract and Refractive Surgery Congress & Symposiumwww.ascrs.org n

London