#########
Volume 17, Number 2
Monday, January 9, 2016
#########


JANUARY IS GLAUCOMA AWARENESS MONTH



In this issue: (click heading to view article)
#########
######### Bimatoprost Sustained-release Implants for Glaucoma Therapy
#########
######### Ranibizumab for Vascularized Pigment Epithelial Detachment
#########
######### 24-Hour IOP Rhythm in Untreated POAG & SLT Effects
#########
######### Responses to Intravitreal Bevacizumab, Ranibizumab & Aflibercept Injections for nAMD
#########
  Briefly

 



Bimatoprost Sustained-release Implants for Glaucoma Therapy

Researchers evaluated the safety and intraocular pressure-lowering effect of a biodegradable bimatoprost sustained-release implant (Bimatoprost SR), as part of a Phase I/II, prospective, 24-month, dose-ranging, paired-eye controlled clinical trial sponsored by Allergan.

At baseline following washout, researchers administered (n=75) Bimatoprost SR (6-μg, 10-μg, 15-μg or 20-μg) intracamerally to open-angle glaucoma subjects in the study eye; the fellow eye began topical bimatoprost 0.03% q.d. They allowed rescue topical IOP-lowering medication or a single repeat treatment with implant. The primary endpoint was IOP change from baseline, and the main safety measure was adverse events reported. Researchers reported results through month six.

Bimatoprost SR provided rapid, sustained IOP lowering. Overall mean IOP reduction from baseline through week 16 in study eyes included the following values with these implant dose strengths: 7.2 mmHg with 6 μg; 7.4 mmHg with 10 μg; 8.1 mmHg with 15 μg; and 9.5 with 20 μg vs. 8.4 mmHg in topical bimatoprost-treated pooled fellow eyes (data censored at rescue retreatment). Rescue retreatment was not required in 91 percent of study eyes up to week 16 and 71 percent of study eyes up to month six. Adverse events in study eyes usually occurred within two days after the injection procedure and were transient. Conjunctival hyperemia with onset later than two days after the injection procedure was more common with topical bimatoprost than Bimatoprost SR (17.3 percent vs. 6.7 percent of eyes).

Researchers concluded that bimatoprost SR demonstrated favorable efficacy and safety through six months. They reported that all dose strengths were comparable to topical bimatoprost in overall IOP reduction through week 16, and a single administration controlled IOP in the majority of individuals for up to six months.

SOURCE: Lewis RA, Christie WC, Day DG, et al. Bimatoprost sustained-release implants for glaucoma therapy: 6-month results from a phase I/II clinical trial. Am J Ophthalmol 2016; Dec. 22. [Epub ahead of print].





Ranibizumab for Vascularized Pigment Epithelial Detachment

Investigators assessed the anatomical and functional efficacy of ranibizumab on vascularized pigment epithelial detachment secondary to neovascular age-related macular degeneration.

They retrospectively selected 109 individuals (116 eyes) from the medical records of 2,097 individuals who received intravitreal injections between January 2011 and June 2013 in a tertiary-care, university-based ophthalmology department. Inclusion criteria were: nAMD; treatment-naive eyes; presence of V-PED higher than 250 μm; intravitreal ranibizumab with a loading phase, followed by a pro re nata regimen and one-year follow-up. Investigators analyzed baseline characteristics and type of choroidal neovascularization, and measured PED height, central macular thickness and best-corrected visual acuity measured at baseline, and months three, six and 12.

CNV was: type 1 in 91 eyes (78.4 percent); type 2 in seven eyes (6 percent); type 3 in six eyes (5.2 percent); and polypoidal choroidal vasculopathy in 12 eyes (10.3 percent). Mean CMT at baseline was 572.1 μm and decreased to 396.6 μm (p<0.0001) at 12 months. Mean height of PED was 458.2 μm at baseline and 306.8 μm (p<0.0001) at 12 months. Mean BCVA improved from 0.46 at baseline to 0.39 at 12 months (p=0.013).

Investigators determined that treatment with ranibizumab improved visual and anatomical outcome in nAMD patients with V-PED.

SOURCE: Chevreaud O, Oubraham H, Cohen SY, et al. Ranibizumab for vascularized pigment epithelial detachment: 1-year anatomic and functional results. Graefes Arch Clin Exp Ophthalmol 2016; Dec 3. [Epub ahead of print].



24-Hour IOP Rhythm in Untreated POAG & SLT Effects

Scientists analyzed the 24-hour nyctohemeral rhythm of intraocular pressure in individuals with untreated primary open-angle glaucoma using a contact lens sensor, and looked at the effect of selective laser trabeculoplasty on the 24-hour rhythm of IOP, as part of a prospective study conducted in a chronobiology center.

Fourteen individuals with POAG underwent three 24-hour IOP measurement sessions after a complete washout of the medical treatment before SLT, and one and six months after using the contact lens sensor Triggerfish (Sensimed). Scientists compared IOP and the main parameters of nyctohemeral rhythm (existence of a rhythm, acrophase, bathyphase, midline estimating statistic of rhythm, amplitude and range) before SLT with the same parameters measured one and six months later.

IOP increased from 16.3 ±3.7 to 22.1 ±8.4 mmHg (5.8 mmHg; CI, 2.41 to 12.71; p=0.009) after the washout procedure. After SLT, IOP significantly decreased by 3.4 mmHg (CI, 0.09 to 7.89; p=0.041) (14.9 percent) at one month and 1.9 mmHg (CI, 0.10-3.84; p=0.044) (8.1 percent) at six months. After medication washout, 100 percent of the subjects had a nyctohemeral IOP rhythm with nocturnal acrophase (01:57 ±3:32 a.m. at inclusion, 01:22 ±3:01 a.m. at one month and 03:17 ±2:12 a.m. at six months). SLT did not significantly change the characteristics of the 24-hour IOP pattern, notably the amplitude and the type of rhythm (persistence of nocturnal acrophase).

Scientists determined that individuals with OAG consistently had a significant 24-hour IOP rhythm with nocturnal acrophase after medical treatment washout. They found that SLT reduced the absolute IOP value but did not modify the nyctohemeral IOP rhythm.

SOURCE: Aptel F, Musson C, Zhou T, et al. 24-hour intraocular pressure rhythm in patients with untreated primary open angle glaucoma and effects of selective laser trabeculoplasty. J Glaucoma 2016; Dec 13. [Epub ahead of print].



Responses to Intravitreal Bevacizumab, Ranibizumab & Aflibercept Injections for nAMD

In a retrospective study, researchers examined 232 eyes of 232 individuals who received intravitreal anti-vascular endothelial growth factor injections due to treatment-naïve nAMD. All individuals, who were followed-up for at least one year, were treated with intravitreal injections monthly until three months, then as needed. Researchers evaluated the effects of intravitreal injections for treatment of nAMD using the central macular thickness, subretinal fluid, pigment epithelial detachment size and best-corrected visual acuity.

CMT, SRF, PED size and BCVA (LogMAR) significantly decreased after treatment with all three anti-VEGF agents. Overall, the bevacizumab, ranibizumab and aflibercept treatments showed no significant differences in responses. However, the aflibercept injections decreased PED size more quickly than bevacizumab injections (p=0.034).

Researchers concluded that bevacizumab, ranibizumab and aflibercept injections were effective for nAMD and had similar responses, although the number of injections of aflibercept was fewer than other anti-VEGF agents. They suggested that aflibercept injections may be a better choice than other anti-VEGF agents for cases of severe increases in PED height.

SOURCE: Park DH, Hae Sun HJ, Lee SJ, et al. A comparison of responses to intravitreal bevacizumab, ranibizumab, or aflibercept injections for neovascular age-related macular degeneration. Int Ophthalmol 2016; Nov 8. [Epub ahead of print].

 

 




  • Alcon Receives FDA Nod for AcrySof IQ Restor +3.0D Multifocal Toric IOL
    Now approved by the FDA, Alcon’s AcrySof IQ Restor +3.0D Multifocal Toric Intraocular Lens is designed to address presbyopia and preexisting corneal astigmatism at the time of cataract surgery in adult patients who desire good near, intermediate and distance vision with an increased potential for spectacle independence. The product is also commercially available in the European Union, Australia, Canada, and several countries in Central and South America, and Asia. Alcon plans to commercialize AcrySof IQ the IOL in the United States on a rolling basis starting in the first quarter of 2017. Read more.



  • Inotek Shares Drop 65 Percent After Glaucoma Treatment Trial Results
    Shares of biotech Inotek Pharmaceuticals Corp. recently dropped about 66 percent in premarket trade after the company said a Phase III trial of trabodenoson for the treatment of primary open-angle glaucoma did not meet its primary endpoint. The drug is the company's leading clinical candidate, but the trial found a placebo response that was greater than observed in the Phase II trial. "We are disappointed that the primary endpoint of superiority at all 12 time points was not achieved," Chief Executive David P. Southwell said. The company says it will see further data later this quarter and will determine its next steps at that time. Read more.



  • FDA Grants Orphan Drug Designation to Profounda
    Profounda received the U.S. Food and Drug Administration's Orphan Drug Designation for the treatment of Acanthamoeba keratitis with miltefosine. Profounda licensed miltefosine (Impavido) from Knight Therapeutics in September 2015. Read more.


  • FDA Approves Genentech’s Lucentis (Ranibizumab Injection) for mCNV
    Genentech announced that the U.S. Food and Drug Administration approved Lucentis (ranibizumab injection) 0.5 mg for the treatment of individuals with myopic choroidal neovascularization, making it the first FDA-approved anti-vascular endothelial growth factor therapy to treat mCNV in the United States. This approval is based on the results of the Phase III RADIANCE study, which demonstrated that treatment with Lucentis provided superior visual acuity gains in people with mCNV compared with verteporfin photodynamic therapy. At three months, average VA gains for individuals treated with Lucentis were more than 12 letters, compared with 1.4 letters for those treated with vPDT. RADIANCE is a Phase III, randomized, double-masked, active-controlled study comparing the efficacy and safety of Lucentis (0.5 mg) vs. vPDT in 276 patients with visual impairment due to mCNV. Subjects were randomized into three treatment groups. Two groups randomized to Lucentis received injections guided by pre-specified retreatment criteria and the third group received treatment with vPDT. At month three, the Lucentis groups I and II had a mean change in best-corrected visual acuity of +12.1 and +12.5 letters from baseline, respectively, demonstrating a statistically significant improvement over the vPDT group III, which had a mean BCVA change of +1.4 letters from baseline. The efficacy between groups I and II were comparable. Adverse events were similar to those seen in other Lucentis trials. This is the fifth FDA-approved indication for Lucentis since the medicine was launched in 2006. Read more.


  • Allegro Completes Enrollment in DEL MAR Phase IIb, Stage II Trial
    Allegro Ophthalmics completed enrollment in the second stage of its DEL MAR trial evaluating the safety and efficacy of Luminate in combination and as an adjunctive therapy with anti-VEGFs in individuals with diabetic macular edema. Topline results from the DEL MAR Stage I monotherapy trial in which Luminate met its primary and secondary endpoints, demonstrating equivalence to bevacizumab monotherapy with half the number of injections, were released in October. DEL MAR Stage II is a double- masked, placebo-controlled, randomized, multicenter, five-month Phase IIb trial designed to evaluate the safety and efficacy of intravitreal injections of Luminate 0.5 mg or 1 mg in combination with bevacizumab 1.25 mg and as an adjunctive therapy after treatment with a single treatment with bevacizumab 1.25 mg in patients with DME. Read more.


  • GenSight Reports Sustained VA Gain in Phase I/II Study
    GenSight Biologics reported additional promising results after 78 weeks of follow-up in its Phase I/II clinical trial. These results confirm the favorable safety and tolerability profile of GS010, while demonstrating sustainable visual acuity improvement in individuals with Leber hereditary optic neuropathy. Each cohort of three individuals was administered an increasing dose of GS010 through a single intravitreal injection in the eye most severely affected by the disease. Recruitment was completed in April 2015 and long-term follow-up is ongoing. Read more.


  • Novartis Bolsters Eye-care Pipeline Through Encore Vision Acquisition
    Novartis entered into a definitive agreement for the acquisition of Encore Vision, focused on the development of a novel treatment in presbyopia. The transaction is subject to customary closing conditions, including regulatory approval, and financial details of the transaction were not disclosed. Encore Vision's lead investigational product, EV06, is a topical treatment for presbyopia. In a phase I/II masked, placebo-controlled proof-of-concept study, 50 individuals were treated daily for 90 days with topical EV06 and 25 people with placebo. EV06 showed a statistically significant difference to placebo in distance-corrected near vision at all time points measured (from day eight). Read more.


  • Health Canada Approves Trab 360 Trabeculotomy System
    Sight Sciences received Health Canada approval for the Trab 360 Trabeculotomy System, indicated in Canada for the microcatheterization of Schlemm's canal and cutting of trabecular meshwork to lower intraocular pressure in patients with primary open-angle glaucoma. From a single clear corneal incision, surgeons can use the system to complete a 360-degree trabeculotomy. Read more.


  • Sun Pharma Announces Positive Topline Results of Phase III Trial
    Sun Pharma announced successful Phase III confirmatory clinical trial results for Seciera (cyclosporine A, 0.09% ophthalmic solution) for the treatment of dry-eye disease. The patented, novel, proprietary nanomicellar formulation of cyclosporine A 0.09% is a clear, preservative-free, aqueous solution developed by Ocular Technologies, recently acquired by Sun Pharma. In the 12-week, multicenter, randomized, double-masked, vehicle-controlled study, 744 dry-eye patients were treated either with Seciera or its vehicle. After 12 weeks of treatment, as compared to vehicle, Seciera showed statistically significant improvement in the primary end point, Schirmer's score (p<0.0001). Read more.



Review of Ophthalmology® Online is published by the Review Group, a Division of Jobson Medical Information LLC (JMI), 11 Campus Boulevard, Newtown Square, PA 19073.

To subscribe to other JMI newsletters or to manage your subscription, click here.

To change your email address, reply to this email. Write "change of address" in the subject line. Make sure to provide us with your old and new address.

To ensure delivery, please be sure to add reviewophth@jobsonmail.com to your address book or safe senders list.

Click here if you do not want to receive future emails from Review of Ophthalmology Online.

Advertising: For information on advertising in this e-mail newsletter or other creative advertising opportunities with Review of Ophthalmology, please contact sales managers James Henne or Michele Barrett.

News: To submit news or contact the editor, send an e-mail, or FAX your news to 610.492.1049