kamra inlay receives fda approval

The FDA has approved the Kamra inlay (AcuFocus), which is indicated to improve near vision by extending depth of focus in presbyopic patients who have emmetropic refractions (+0.50 D to -0.75 D). The approval, announced on April 17, 2015, represents the first major advancement in the surgical correction of presbyopia in over a decade.

“Today is a momentous occasion, not only for AcuFocus but for the whole industry, because this is a first-of-its-kind therapy in the United States and really is trailblazing for other entities to attack presbyopia,” Jim Mazzo, chairman and CEO of AcuFocus, said in an interview with “Presbyopia affects a lot of people and what the Kamra inlay is going to be able to do is take care of near all the way through to distance [vision]. We are thrilled with this approval.”

The Kamra inlay approval was based on the results of 508 patients treated at 24 investigational sites worldwide. Patients in the clinical study experienced an average improvement in uncorrected near visual acuity of 3 lines between their preoperative exam and the 12-month follow-up visit. This improvement was maintained over the 5-year duration of the study. Mean preoperative uncorrected distance visual acuity in the inlay-implanted eye was maintained across all follow-up examinations, according to an AcuFocus news release.

“Near-vision loss from presbyopia can be a significant challenge in the everyday lives of patients, especially those who are emmetropic, which means they previously enjoyed normal vision without the need for glasses, contacts, or other correction,” Daniel S. Durrie, MD, founder of Durrie Vision, Overland Park, Kansas, said in the news release. “With the approval of the Kamra inlay, we now have a reliable solution for presbyopes who want to enjoy many daily activities without reading glasses.”

The Kamra inlay is an ultra-thin opaque ring that is implanted monocularly into the patient’s nondominant eye. The device utilizes the principle of small-aperture optics, or pinhole effect, to extend depth of focus for patients suffering from age-related near-vision loss. The inlay measures 3.8 mm in total diameter and has a 1.6-mm central aperture. As a result of this design, central focused light is allowed to reach the retina uninterrupted, resulting in functional vision from near to far without reading glasses, according to AcuFocus.

Dr. Durrie is a consultant to AcuFocus.

Rhopressa Phase 3 Trial (Rocket 1) Misses Primary Endpoint

Aerie Pharmaceuticals reported that their phase 3 registration trial (Rocket 1) did not meet its primary efficacy endpoint of demonstrating noninferiority of intraocular pressure (IOP) lowering for once-daily Rhopressa compared to twice-daily timolol, the most widely used comparator in registration trials for glaucoma, according to a company news release.

Rhopressa, a novel once-daily, triple-action eye drop is being tested for its ability to lower IOP in patients with glaucoma or ocular hypertension.

Rhopressa did demonstrate noninferiority compared to timolol for patients in the study with IOP below 26 mm Hg at all nine measured time points, and numerical superiority over timolol at the majority of measured time points, according to Aerie. Approximately 80% of glaucoma patients have an IOP of 26 mm Hg or less at the time of diagnosis.

Rhopressa did not meet its primary efficacy endpoint of demonstrating noninferiority of IOP lowering for Rhopressa compared to twice-daily timolol, based upon IOP measurements at the end of week 2, week 6, and day 90. The Rocket 1 study included 182 patients in the Rhopressa once-daily arm and 188 patients in the timolol twice-daily arm. The baseline IOPs tested in the study ranged from above 20 mm Hg to below 27 mm Hg. In addition, the results showed a slight loss of efficacy in the week-6 and day-90 measurements. Across the Rhopressa study of 182 patients, 36 patients or approximately 20% showed signs of loss of efficacy during the study. The primary adverse event was hyperemia, which was experienced by approximately 35% of the Rhopressa patients, of which 80% was reported as mild.

“We are obviously disappointed that we missed the primary endpoint for Rocket 1,” Vicente Anido, Jr, PhD, chairman and CEO of Aerie, said in the news release. “We expected Rhopressa to demonstrate better performance based on the results we saw in the previous phase 2b studies. However, if we had set the high end of the baseline range just 1 mm Hg less, we would have demonstrated noninferiority compared to timolol at all nine measured time points and numerical superiority at the majority of time points. We believe Rhopressa shows great promise at IOPs where the majority of patients are represented. Also, we believe the meaningful decrease in the number of patients that experienced efficacy loss at the lower baseline IOPs supports the potential benefit of the Rhopressa on episcleral venous pressure.”

Allegro Begins Phase 2 Trials of Luminate for Nonproliferative Diabetic Retinaopthy

Allegro Ophthalmics announced that it has begun enrolling patients in a Phase 2 clinical trial that will evaluate the safety and efficacy of the company’s first-in-class integrin peptide therapy candidate Luminate (ALG-1001) in inducing posterior vitreous detachment in patients with nonproliferative diabetic retinopathy.

“We have already seen good evidence that Luminate can induce [posterior vitreous detachment] in patients with diabetic macular edema,” said Baruch Kuppermann, MD, PhD, professor of ophthalmology and biomedical engineering, chief of the Retina Service, and vice-chair of academic affairs at the Gavin Herbert Eye Institute, University of California Irvine School of Medicine, and member of Allegro’s Scientific Advisory Board. “I am pleased to participate in this important study to broaden and confirm our understanding of this nonsurgical option for patients with mild to moderate nonproliferative diabetic retinopathy who may potentially proceed to vision threatening disease over time. In early phase clinical studies to date, Luminate has been shown to be effective as monotherapy treatment and to meaningfully reduce the burden of intravitreal injections in [diabetic macular edema] and wet [age-related macular degeneration],” he said in the news release.

This phase 2 study is a randomized, double-masked, placebo-controlled, multicenter dose-ranging trial to evaluate the safety and efficacy of intravitreal injections of Luminate in patients with nonproliferative diabetic retinopathy, the company stated. Patients will be randomized to one of four treatment groups that include three Luminate groups (1 mg, 2 mg, or 3 mg) and a placebo group. All study subjects will return for examinations every four weeks for three months. Total planned enrollment for the trial is 100 subjects.

Bausch + Lomb Reports Resistance Patterns for Key Ocular Pathogens: ARMOR Update

Bausch + Lomb announced the results from the sixth consecutive year of the ARMOR (Antibiotic Resistance Monitoring in Ocular MicrooRganisms) surveillance study in the United States as presented at the 2015 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting.1 Initiated in 2009, ARMOR is the only multi-center, national survey of antibiotic resistance patterns specific to eye care, according to a news release.

In the ARVO presentation, researchers reported year-over-year comparisons of susceptibility rates based on 2013 data on 496 bacterial isolates collected from 22 participating sites and preliminary 2014 data on 141 isolates collected from 7 participating sites. The survey included all of the organisms most frequently implicated in serious bacterial eye infections, including Streptococcus pneumoniae, Staphylococcus aureus, coagulase-negative staphylococci (CoNS), Pseudomonas aeruginosa, and Haemophilus influenzae.

Similar to previous years, high levels of resistance (full resistance and intermediate resistance) were observed. Approximately one in two S pneumoniae isolates were resistant to penicillin, and two in five were resistant to azithromycin. During this period, tobramycin resistance among CoNS increased, while resistance rates for azithromycin remained stable. All H influenzae isolates were susceptible to all drugs tested, with few exceptions. Methicillin resistance among staphylococci remains high with one in four S aureus and one in two CoNS (eg, S epidermidis) isolates resistant. Many methicillin-resistant staphylococci were multidrug resistant.

“As the ARMOR survey makes clear, antibiotic resistance by significant ocular pathogens is a moving target,” said Penny A. Asbell, MD, lead ARMOR study author, professor of ophthalmology at Icahn School of Medicine at Mount Sinai, and director of the Cornea Service and Refractive Surgery Center at Mount Sinai Hospital. “This ongoing surveillance effort is the only epidemiological data available to help eye care providers maintain the effectiveness of ocular infection control by tracking actual susceptibility rates for commonly used antibiotics. The ability to identify resistance trends over time is particularly useful for guiding treatment decisions for ocular infections,” she said in the news release.

1. Asbell PA, Sanfilippo CM, Sahm FD, et al. Antibiotic resistance among ocular pathogens–results from the ARMOR surveillance study 2013-present. Poster presented at: The Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting; May 3, 2015; Denver, CO.

Shire, Foundation Fighting Blindness Announce Research Agreement for Rare Childhood Disease

Shire and the Foundation Fighting Blindness announced a new agreement focused on furthering research for a novel treatment for autosomal dominant retinitis pigmentosa (adRP), a rare genetic disease that usually first occurs in late childhood or adolescence and is followed by the progressive loss of peripheral vision. There are no currently approved treatment options for adRP, according to a news release from Shire.

“This agreement is an example of the creative approaches in early-stage rare disease research and development that we’re taking at Shire,” said Albert Seymour, Shire senior vice president of Global Research and Nonclinical Development. “Both organizations have a strong, shared commitment to unearthing and developing innovative treatments in areas of significant, unmet medical need.”

As part of the agreement, the Foundation Fighting Blindness and its research partners will provide Shire with expert knowledge and scientific background regarding adRP, as well as pertinent clinical information that could be useful in the development of a drug to treat adRP. Backed by its scientific advisory board, the Foundation Fighting Blindness will also provide counsel as requested on the pre-clinical and/or clinical development of Shire compounds in development for the treatment of adRP, according to the company.

“Through our agreement with Shire, we are excited to drive research and development and extend our expertise to dedicated partners working to accelerate treatments for those living with retinal diseases,” said Patricia Zilliox, chief drug development officer, Foundation Fighting Blindness Clinical Research Institute.

FDA Approves AcrySof IQ Restor +2.5 D Multifocal IOL

Alcon received approval from the FDA for its AcrySof IQ Restor +2.5 Diopter IOL for the correction of near, intermediate, and distance vision. The Centers for Medicare and Medicaid Services added the AcrySof IQ Restor +2.5 D IOL to the list of its recognized presbyopia-correcting IOLs, confirming that AcrySof IQ Restor +2.5 D IOLs will be eligible for reimbursement as both a Medicare-covered service (treatment of cataract) and as a noncovered service (presbyopia correction). Alcon will commercialize the AcrySof IQ Restor +2.5 D IOL in the United States in the near future.

“With the addition of AcrySof IQ Restor +2.5 D IOL, surgeons now have a broader range of treatment options to meet the vision needs of cataract patients seeking presbyopia correction, based on various lifestyle requirements,” Lisa Cibik, MD, director of cataract services at Associates in Ophthalmology of Pittsburgh, said in the news release. “The Restor +2.5 D IOL helps surgeons meet the needs of cataract patients with active lifestyles.” n

Dr. Cinik is a consultant to and speaker for Alcon.