EW Weekly, February 19, 2016

February 19, 2016
Volume 21 , Number 7

Alcon enters into agreement to acquire Transcend Medical

Alcon (Fort Worth, Texas) announced that it has entered into an agreement to acquire Transcend Medical (Menlo Park, Calif.), a company focused on developing minimally invasive surgical devices to treat glaucoma. Transcend Medical recently developed a micro-stent to treat mild to moderate glaucoma. The device currently has CE mark approval in Europe and is awaiting U.S. Food and Drug Administration approval.

Ocular Therapeutix announces phase 3 clinical development plan for OTX-TP

Ocular Therapeutix (Bedford, Mass.) announced plans for phase 3 clinical development of OTX-TP, a drug therapy for glaucoma and ocular hypertension. The company has plans for two phase 3 clinical trials, with the first set to begin in the third quarter of this year. The trials will use OTX-TP and placebo groups. It is expected that the primary efficacy endpoint for OTX-TP will be a statistically superior and clinically meaningful reduction of IOP. The company recently met with the FDA, and plans for the clinical trials moved forward after this interaction. Ocular Therapeutix expects to work further with the FDA as it moves into these clinical trials.

Aerie Pharmaceuticals reports successful 12-month safety results of Rocket 2

Aerie Pharmaceuticals (Irvine, Calif.), a glaucoma therapy company, announced successful 12-month interim safety results of Rocket 2, the company's second phase 3 registration trial for Rhopressa (netarsudil ophthalmic solution) 0.02%. Rhopressa is a once daily eye drop that Aerie is testing for its ability to lower IOP in patients with glaucoma or ocular hypertension. In previous results, Rocket 2 achieved its primary 90-day efficacy endpoint of demonstrating non-inferiority of IOP lowering for Rhopressa QD compared to timolol BID, according to the company's press release. Aerie Pharmaceuticals said it expects the Rocket 2 trial to be part of the NDA filing for Rhopressa, and the company expects to submit to the FDA in the third quarter of 2016.

IRIDEX Cyclo G6 laser system receives CE approval

The Cyclo G6 laser system (IRIDEX, Mountain View, Calif.) was recently given CE mark approval in Europe. This approval allows the company to commercialize across Europe, and IRIDEX said in a press release that the Cyclo G6 is the "first laser system in its class designed solely for use in treating glaucoma and its symptoms." This laser system treats patients diagnosed with varying degrees of glaucoma, and it uses the company's proprietary MicroPulse tissue-sparing technology and a family of single-use probes that connect to a laser console. The company said that the Cyclo G6 laser system will be sold with two disposable probes, the MicroPulse P3 probe for use with a broad range of glaucoma patients and the G-Probe for later stage patients. IRIDEX plans to introduce new probes in the coming year that allow for additional applications for glaucoma.

Ocular graft versus host disease and dry eye disease treatment addressed

Ocugen (Malvern, Pa., and Aurora, Colo.), a biopharmaceutical company, announced that it has licensed a clinical-stage asset from the University of Chicago (UIC) that will be developed for the treatment of ocular graft versus host disease (oGVHD) and other dry eye diseases. Additionally, the company has applied for a patent for OCU200, a preclinical asset in development to treat wet age-related macular degeneration and other neovascular diseases. According to a press release, "Ocugen executed an exclusive worldwide license agreement with UIC on OCU300, which will be developed as a re-purposed drug under the U.S. Food and Drug Administration's 505(b)(2) regulatory pathway." The company estimates from data from an exploratory observational study that about 90% of patients will benefit from this treatment. The company said it plans to conduct a dose-finding study for OCU300 in the coming months and anticipates initiating phase 3 clinical trials in 2017.

Partnership targets ending cataract blindness in India's largest state

A partnership between HelpMeSee and the Lions Health Foundation Alibag, India has been launched to try to end cataract blindness in India's largest state of Maharashtra. One of the main goals of the partnership is to focus on training in manual small incision cataract surgery (MSICS) and the use of surgical quality assurance systems, according to a press release. Another focus will be on the construction of a new hospital in Raigad District, the initial focus area for the joint campaign. According to a press release, "cataracts cause nearly two-thirds of all blindness in India, where over five million are estimated to be blind." HelpMeSee will bring two of its key technologies to the partnership in Raigad, including the HelpMeSee Reach App for population-based patient services, and a pre-sterilized, single-use, disposable surgical kit for MSICS.


  • Researchers concluded that autologous simple limbal epithelial transplantation (SLET) is an "effective, reliable and replicable technique" that can be used for long-lasting corneal regeneration and vision restoration in unilateral chronic ocular surface burns, based on long-term clinical outcomes. Sayan Basu, MBBS, MS, and colleagues conducted a single-center, prospective, interventional case series with 125 patients. Of these patients, there were 65 adults and 60 children who developed unilateral limbal stem cell deficiency (LSCD) after suffering from ocular surface burns. SLET was conducted between 2010 and 2014. With a median postop follow-up of 1.5 years, the researchers found that 95 of 125 eyes maintained a successful outcome, with 75.2% of the patients showing a two-line improvement in visual acuity. The primary outcome measure was "restoration of a completely epithelized, stable, and avascular corneal surface," with a secondary outcome of improvement in visual acuity. The study is published online in Ophthalmology.
  • A systematic review and meta-analysis of global myopia prevalence has estimated a significant increase in myopia worldwide when looking at myopia and high myopia from 2000 to 2050. Brien Holden, PhD, and colleagues conducted the review to estimate trends by including data from 145 studies covering 2.1 million participants. The researchers found about 1.406 billion people with myopia and 163 million with high myopia in 2000, and they predicted that by 2050, there will be 4.758 billion people with myopia and 938 million with high myopia worldwide. The review is published online in Ophthalmology.
  • Performing cataract surgery in nanophthalmic eyes can present its own unique set of challenges, according to José A. Lemos and colleagues. They conducted a retrospective review of 9 patient records who had cataract surgery between January 2011 and January 2015. Phacoemulsification seems to be safe in nanophthalmic eyes, they concluded, and although surgeons should be aware of challenges associated with these "high-risk" eyes, most cases can proceed without complication if careful preoperative evaluation and planning is taken into consideration. The study was published online in the European Journal of Ophthalmology and found that mean preoperative spherical equivalent was reduced at the time of the last follow-up visit and mean best corrected visual acuity improved, although complications did occur in 3 eyes.

EYEWORLD WEEK Online is edited by Stacy Majewicz and Michelle Dalton.

EyeWorld Week Online (ISSN 1089-0319), a digital publication of the American Society of Cataract and Refractive Surgery and the American Society of Ophthalmic Administrators, is published every Friday, distributed by email, and posted live on Friday.

Medical Editors: Eric Donnenfeld, MD, chief medical editor; Rosa Braga-Mele, MD, cataract editor; Clara Chan, MD, cornea editor; Nathan Radcliffe, MD, glaucoma editor; and Vance Thompson, MD, refractive editor.

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