EW Weekly, April 22, 2016

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April 22, 2016
Volume 21 , Number 15

FDA approves crosslinking in the U.S.

The Food and Drug Administration granted regulatory approval for Photrexa Viscous, Photrexa and the KXL System for the treatment of progressive keratoconus, said developer Avedro (Waltham, Massachusetts) in a press release. Photrexa Viscous and Photrexa are photo enhancers indicated for use with the KXL System in corneal collagen crosslinking, and together represent a first-in-class therapeutic treatment. Approval was based on data from prospective, randomized, parallel-group, open-label, placebo-controlled, 12-month trials conducted in the United States to determine the safety and effectiveness of Photrexa Viscous and Photrexa. In each study (n=58 in Study 1, n=147 in Study 2), patients had 1 eye designated as the study eye and were randomized to receive 1 of 2 study treatments (CXL or sham) in their study eye. The crosslinked eyes showed increasing improvement in Kmax from month 3 through month 12. Progressive keratoconus patients had an average Kmax reduction of 1.4 D in Study 1 and 1.7 D in Study 2 at month 12 in the crosslinked eyes, while the untreated eyes had an average increase of 0.5 D in Study 1 and 0.6 D in Study 2 at month 12. In clinical studies, the most common ocular adverse reactions in any crosslinked eye were corneal opacity (haze), punctate keratitis, corneal striae, corneal epithelium defect, eye pain, reduced visual acuity, and blurred vision. Avedro also noted ulcerative keratitis can occur. Avedro plans to launch the system immediately, and will begin shipping the Photrexa products over the next few months, company executives said.

Nicox submits NDA for ocular itching drug

AC-170, a novel, proprietary, cetirizine eye drop formulation for the treatment of ocular itching associated with allergic conjunctivitis, has been submitted to the Food and Drug Administration, developer Nicox (Sophia Antipolis, France) noted in a press release. Based on clinical pediatric data generated with AC-170, Nicox requested a Priority Review, which means the FDA could make its decision before the end of the year. AC-170 is a novel topical formulation of cetirizine, a second generation antihistamine and mast cell stabilizer that binds competitively to histamine receptor sites to reduce swelling, itching, and vasodilation. Cetirizine, as an approved oral drug, has a well-characterized systemic safety and efficacy profile with worldwide exposure representing more than 300 million patient years, Nicox noted. Two phase 3 safety and efficacy trials have been completed using the conjunctival allergen challenge (CAC) model of allergic conjunctivitis. Both phase 3 clinical trials demonstrated statistically significant results for AC-170 compared to vehicle control (placebo) for the primary endpoint of ocular itching. Treatment emergent adverse events were similar in severity and frequency within the active and placebo groups.

First patient enrolled in squalamine study for AMD

The first patient has been enrolled in a phase 3 study on squalamine lactate ophthalmic solution, 0.2% (also known as OHR-102), for the treatment of neovascular age-related macular degeneration (wet AMD), developer Ohr Pharmaceutical (New York) said in a press release. The first of 2 randomized, double-masked, placebo-controlled trials will include approximately 165 centers in the United States and Canada with a target enrollment of 650 treatment-naïve subjects with wet AMD. In March 2016, Ohr reached an agreement on a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA). The comprehensive phase 3 clinical program will be comprised of double-masked, placebo-controlled, multicenter, international studies of squalamine lactate ophthalmic solution, 0.2%, administered twice a day in subjects with newly diagnosed wet AMD, in combination with ranibizumab injections. The primary endpoint will be a measurement of visual acuity gains at 9 months, with subjects followed to 2 years for safety.

Ab interno canaloplasty safe, effective for POAG

A 12-month case series review of 228 patients with primary open-angle glaucoma (POAG) has found that ab interno canaloplasty (ABiC) helps to reduce IOP and medication dependence with minimal complications, according to developer Ellex Medical Lasers (Adelaide, Australia). ABiC is a U.S.-approved evolution of "tried-and-tested" traditional ab externo canaloplasty, a bleb-free procedure that uses Ellex's proprietary iTrack 250-micron microcatheter to circumferentially viscodilate Schlemm's canal in order to restore natural aqueous outflow. ABiC differs from traditional canaloplasty only in that it does not require a tensioning suture to maintain the IOP reduction, and the procedure spares conjunctival manipulation for future procedures if required. Data for the entire patient cohort show that at 12 months post-ABiC, there was a total average decrease of 30% in IOP and a 50% reduction in medications from 19.0 mm Hg±6.5 SD on 2±1 medications to 13.3±2.0 mm Hg on 1±1 medications. In 127 patients who underwent ABiC combined with phacoemulsification, there was a mean decrease of 23.39% in IOP and 50% reduction in medications from 17.1 mm Hg±5.0 on 2 gtts±1.0 preoperatively to 13.1 mm Hg±2.1 on 1 gtts±1.0 at 12 months. Findings also showed that there was a total average decrease of 38.88% in IOP and 50% in medications in patients with uncontrolled glaucoma (IOP≥16 mm Hg, n=161) while patients with controlled glaucoma (IOP≤15 mm Hg, n=67) benefited from a 50% reduction in medication use. There were no complications or safety issues.

RESEARCH BRIEFS

  • The role of amniotic membrane in modulating wound healing after PRK remains speculative, even though the amniotic membrane graft was reasonably well tolerated with few significant adverse effects, according to a study published in the Journal of Cataract & Refractive Surgery. A. Vlasov and colleagues evaluated the effect of sutureless cryopreserved amniotic membrane (Prokera, Bio-Tissue, Doral, Florida) on corneal wound healing in 40 patients who underwent PRK for myopia with or without astigmatism. Postoperatively, patients were evaluated daily until complete corneal re-epithelialization occurred in both eyes and then at 2 weeks and 1, 3, 6, and 12 months. The amniotic membrane graft sped corneal re-epithelialization 1 day after PRK, but was not better than the bandage contact lens in hastening complete re-epithelialization of the cornea. Visual outcomes, corneal clarity, and optical quality of the cornea were comparable between the amniotic membrane graft eyes and bandage contact lens eyes.
  • The 25-gauge vitrectomy system allows sutureless surgery with excellent intraoperative control and minimal postoperative inflammation and astigmatism with clear visual axis by both the transcorneal and pars plana routes during pediatric cataract surgery, according to a new study from U.K. Raina and colleagues. Their prospective interventional study included 12 pediatric patients younger than 1 year with bilateral congenital cataract scheduled to undergo cataract surgery with posterior vitreorhexis and limited anterior vitrectomy using a 25-gauge vitrectomy system. All eyes were left aphakic, and rehabilitated with contact lenses or spectacles. The 25-gauge vitrectomy system allowed excellent intraoperative control in both groups. Postoperatively, there was minimal conjunctival congestion, corneal edema, and inflammatory reaction. No intraoperative or postoperative complications were noted in any eye. All eyes had a clear visual axis 12 months after surgery. Mean spherical equivalent was 15.50±2.28 D, and mean astigmatism was 0.25±0.45 D in the transcorneal group, whereas in the pars plana group it was 15.46±2.45 D and 0.16±0.39 D, respectively, at 12 months, the difference being statistically insignificant (P>.05). The study is published in the Journal of Pediatric Ophthalmology and Strabismus.
  • Pre-Descemet's endothelial keratoplasty (PDEK) tissue scrolls less than Descemet's membrane (DM), and pre-Descemet's layer (Dua's layer [PDL]) scrolls the least, according to H. Dua and colleagues. Fourteen human donor sclero-corneal discs where a type 1 big bubble was obtained by stromal injection of air were studied. The wall of the type 1 big bubble was excised and its grade of scrolling noted. The components of the wall (the DM and PDL) were then separated and the scrolling of each was individually graded. Mean donor age was 67 years. The mean grade of the scroll formed by PDEK tissue was 1.6 compared to 0.64 for PDL alone and 3.6 for DM alone. The difference was statistically significant. No correlation between donor age and degree of scrolling for any of the tissues tested was found. The study is published in the American Journal of Ophthalmology.

NEW PRODUCT BRIEFS

  • Beaver Visitec International (Waltham, Massachusetts) globally launched a multi-functional cannula, designed to improve surgical efficiency and optimize clinical outcomes during femto laser-assisted cataract surgery (FLACS). Because it is a single-use device supplied in a manufacturer-sealed sterile package, the Visitec FLACS Cannula eradicates the risk of cross-contamination associated with reusable instruments and eliminates the need for costly and time-consuming sterilization protocols, the company said.

Important Safety Information about PROLENSA®

  •  PROLENSA®contains sodium sulfite, a sulfite that may cause allergic type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non asthmatic people.
  • All topical nonsteroidal anti-inflammatory drugs (NSAIDs), including bromfenac, may slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems.
  • There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs, including bromfenac. Use with caution in patients who have previously exhibited sensitivities to these drugs.
  • There have been reports that ocularly applied NSAIDs may cause increased bleeding of ocular tissues (including hyphemas) in conjunction with ocular surgery. Use with caution in patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time.
  • Use of topical NSAIDs may result in keratitis. Patients with evidence of corneal epithelial breakdown should immediately discontinue use of topical NSAIDs, including bromfenac, and should be closely monitored for corneal health. Patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases (e.g., dry eye syndrome), rheumatoid arthritis, or repeat ocular surgeries within a short period of time may be at increased risk for corneal adverse events which may become sight threatening.
  • Topical NSAIDs should be used with caution in these patients. Post-marketing experience with topical NSAIDs suggests that use more than 24 hours prior to surgery or use beyond 14 days post-surgery may increase patient risk for the occurrence and severity of corneal adverse events.
  • PROLENSA®should not be instilled while wearing contact lenses. The preservative in PROLENSA®, benzalkonium chloride, may be absorbed by soft contact lenses. Lenses may be reinserted after 10 minutes following administration of PROLENSA®.
  • The most commonly reported adverse reactions in 3%-8% of patients were anteriorchamber inflammation, foreign body sensation, eye pain, photophobia, and blurred vision. 

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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