News

ALLERGAN ACQUIRES FORSIGHT VISION5

Allergan and ForSight VISION5 announced that they have entered into an agreement under which Allergan will acquire ForSight VISION5 for a $95 million upfront payment and a launch milestone payment related to ForSight’s lead development program, a periocular ring designed for extended drug delivery and reducing elevated intraocular pressure (IOP) in glaucoma patients.

The ring is a preservative-free, noninvasive periocular product that rests on the surface of the eye (under the eyelids). It is inserted by an ophthalmologist or optometrist and releases bimatoprost over multiple months to lower elevated IOP in glaucoma and ocular hypertensive patients.

In 2015, ForSight announced results of its first randomized, controlled phase 2 study comparing the investigational ring to twice-daily timolol eye drops. Data demonstrated that a single administration of the ring provided sustained reduction in IOP for 6 months with a reduction of 4-6 mm Hg at the study’s primary endpoint of 12 weeks. Approximately 90% of subjects retained inserts in both eyes for 6 months without clinician assistance.

“ForSight’s ring technology has been shown to provide long-term intraocular pressure reduction through a noninvasive, passive technology for glaucoma and ocular hypertensive patients. If approved, this technology could provide an important advance to address the significant challenges of patient compliance and adherence in glaucoma, a disease that is expected to impact more than 80 million people worldwide by 2020 and be a leading cause of blindness globally,” David Nicholson, Chief R&D Officer, Allergan, said in a company news release. “Importantly, this technology would also be highly complementary to our ongoing portfolio and development programs that are moving glaucoma treatment toward dropless therapies.”

“With its historic expertise in eye care innovation and commercialization, its strong collaboration with the eye care community and its commitment to being a leading provider of game-changing dropless treatments for glaucoma, Allergan was a natural choice and a compelling partner for us to maximize the potential of our ring technology,” said Andy Corley, executive chairman, ForSight VISION5. “The addition of the ring technology to Allergan’s world class eye care development and commercialization organization represents a great day for clinicians and patients seeking an innovative solution for the challenges of glaucoma treatment.”

“A safe and effective extraocular drug delivery therapeutic option is particularly suitable for the many patients with mild-to-moderate glaucomatous disease in whom more invasive modalities may not be ideal from a risk/benefit standpoint,” said Kuldev Singh, MD, professor of ophthalmology and director of the Glaucoma Service, Stanford University.

The transaction is subject to the satisfaction of customary closing conditions and is expected to be completed within 60 days.

 


 

Shire’s Lifitegrast Now Available

Shire announced that Xiidra (lifitegrast ophthalmic solution) 5%, a twice-daily prescription eye drop indicated for the treatment of the signs and symptoms of dry eye disease (DED), is now available by prescription in the United States. The US Food and Drug Administration approved Xiidra on July 11, 2016.

“Shire worked rapidly to bring Xiidra to market following the approval of this new treatment—a first-in-its-class medication and the first prescription treatment to be approved for both the signs and symptoms of DED,” Perry Sternberg, head, US commercial, said in a company news release. “We have a full range of modern, educational access programs to support the millions of patients across the US living with DED. This delivers on our commitment to showing up differently in ophthalmics.”

“As the number of people presenting with the signs and symptoms of dry eye disease increases, the availability of a new prescription treatment option for this condition is an exciting development,” Eric D. Donnenfeld, MD, FAAO, national medical director, TLC Laser Eye Centers, said in the news release. “We now have a new prescription eye drop that is specifically indicated for the signs and symptoms of dry eye disease, an often common eye condition that may be progressive.”

With the availability of Xiidra, Shire has patient-focused resources to share information about prescription coverage and savings (subject to eligibility):

• Ask iiris, a phone service offering live-person responses to questions regarding information about insurance coverage, benefits, copays and availability in pharmacies. To ask iiris, call 1-844-my-iiris.

• Xiidra iinsider, an optional program that patients can sign up for to receive information and special offers, either via text or email.

Shire also announced that it has partnered with Jennifer Aniston to raise awareness of DED via the eyelove Campaign.

According to a news release, Jennifer Aniston is one of the millions of Americans who experience symptoms consistent with chronic dry eye. In partnership with Shire, Ms. Aniston is encouraging people to make eye health a priority, and is raising awareness and understanding about chronic dry eye symptoms, like the ones she experiences. She hopes to educate and inspire people to chat with their eye doctor about what’s really going on with their eyes.

 


 

ReVision Optics Announces First US Commercial Cases of Raindrop Inlay

ReVision Optics announced the US commercial launch of the Raindrop Near Vision Inlay. The initial launch plan calls for the company’s direct field force to focus on sites that participated in the US investigational device exemption clinical trial, followed by a more broad-based expansion later in 2016.

“We are excited to kick-off our US launch with procedures performed by an outstanding group of ophthalmologists including Drs. Stephen Slade, Jeffery Whitman, Greg Parkhurst, and Ralph Chu who treated patients last month in Houston and San Antonio, Texas, and in Bloomington, Minnesota,” John Kilcoyne, ReVision Optics President and Chief Executive Officer, said in the news release. “All of these surgeons are driving forces behind commercialization of the Raindrop Near Vision Inlay, having served as investigators in our clinical study.”

The Raindrop Near Vision Inlay is a novel corneal inlay for the surgical correction of presbyopia, which is a natural part of the aging process that decreases the ability of the eye to focus on near objects. The Raindrop is a clear, biocompatible inlay that is placed in the nondominant eye in a 10-minute outpatient procedure. It is about the size of a pinhead and is less than half the thickness of a human hair. It mimics the natural cornea by changing the central curvature of the eye to improve near vision.

“It is highly gratifying to successfully perform the first US commercial case with the Raindrop Near Vision Inlay,” said Dr. Slade. “Over the years in my practice I’ve continually heard from patients with presbyopia looking for an alternative to reading glasses. The Raindrop Near Vision Inlay provides that solution and brings what we call the ‘wow’ factor to these patients with quickly enhanced near and intermediate vision, without impairing binocular distance vision.”

 


 

Bio-Tissue Collaborates With SightLife

Bio-Tissue has announced a strategic collaboration agreement with SightLife, a Seattle-based eye bank and the largest provider of corneal tissue for transplant. As part of the agreement, SightLife, which is the preferred supplier of corneal tissue for Kaiser Permanente, will provide Bio-Tissue’s cryopreserved amniotic membrane ocular wound healing products to hospitals and eye clinics in Kaiser Northern California, Southern California, and the Pacific Northwest.

“Our collaboration with SightLife will support our efforts to further expand use of our cryopreserved amniotic membrane products within Kaiser Permanente facilities,” Thomas G. Daniells, chief commercial officer, Bio-Tissue, said in a company news release. “SightLife’s expertise and experience working with Kaiser Permanente doctors and hospitals makes the organization an ideal partner to provide our products to Kaiser facilities for the treatment of ocular surface diseases and conditions.”

As part of the collaboration with Bio-Tissue, SightLife will provide Kaiser facilities with Bio-Tissue’s AmnioGraft biologic ocular transplantation graft, AmnioGuard biologic glaucoma shunt tube graft, and Prokera biologic corneal bandage devices, the only therapeutic devices cleared by the FDA that reduce inflammation and promote regenerative healing of the ocular surface, according to Bio-Tissue.

SightLife and its global partners provided nearly 24,600 corneas for transplant in 33 countries in 2015.

 


 

Haag-Streit Introduces the Fundus Module 300: Instant Fundus Imaging on the Slit Lamp

Haag-Streit has introduced the Fundus Module 300, which offers users of current Haag-Streit slit lamps access to instant documentation of the retina. The simplicity of the Fundus Module 300 allows integration of nonmydriatic retina imaging as part of the regular slit-lamp examination, the company stated. This can improve practice workflow and save both clinical and patient time, according to a company news release.

Taking the Fundus Module 300 from the cradle and putting it on the slit lamp reportedly takes only a few seconds. On the slit lamp it provides two states: a working position where it captures images of the fundus, and a stand-by position where it allows normal use of the slit lamp. The image quality of the Fundus Module 300 exceeds the conventional possibilities on slit lamps. It stands up to comparison with full-blown screening fundus cameras, according to Haag-Streit. n