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Volume 15, Number 14
17 June 2010



Macugen 'significantly' improves vision in DME patients
A Phase III clinical study of age-related macular degeneration drug Macugen (pegaptanib, Pfizer, New York, NY, USA) found the drug "significantly improved vision in patients with diabetic macular edema (DME)", the company said in a press release.
The study is a multicenter, randomized, sham-controlled, double-masked, comparative Phase III trial over two years with an open-label year-three extension. The primary analysis included 260 patients with DME at 56 global sites. The primary objective of the study was to evaluate whether Macugen improved vision compared with sham injections in patients with DME and to assess the safety of Macugen in these patients.
In this fully masked study, patients received an injection of 0.3 mg Macugen or a sham procedure every six weeks for a total of nine injections in year one. In year two, subjects could receive injections as often as every six weeks based on pre-specified criteria, including visual acuity, clinical examination, optical coherence tomography (OCT), and the opinion of the investigator. In the study, 37% of patients treated with Macugen gained two lines, or 10 letters, of vision on the ETDRS eye chart at 54 weeks, compared with 20% of patients who received a sham procedure which consisted of anesthesia and a simulated injection in the eye (P=0.0047).
The Phase III study met its primary endpoint of the proportion of patients gaining greater than 10 letters vs. sham at one year. On average, patients treated with Macugen gained 5.2 letters of vision at year one compared with 1.2 letters for patients receiving sham (P<0.05). At the end of year two, patients receiving Macugen had gained on average 6.1 letters of vision compared with 1.3 letters for patients in the sham arm of the study (P<0.01).
Pfizer said it plans to submit to submit a variation of the European Marketing Authorization for Macugen that includes an indication for DME to the European Medicines Agency, although the company did not indicate a timeline for its filing.


B+L acquires herpetic keratitis drug
Bausch + Lomb (Rochester, NY, USA) has acquired the assets to acute herpetic keratitis drug Zirgan (ganciclovir ophthalmic gel 0.15%) from Sirion Therapeutics (Tampa, FL, USA). Zirgan was approved by the US Food and Drug Administration in 2009 as a topical anti-viral for the treatment of acute herpetic keratitis.
Ganciclovir—marketed as Virgan in Europe—is considered the standard of care for the treatment of corneal ulcers caused by the herpes virus, B+L said in a press release. Unlike older anti-viral pharmaceuticals that affect both healthy and infected cells, Zirgan selectively targets the replication of herpes simplex virus DNA, according to B+L. It has a low corneal toxicity profile to provide patients with comfort and relief. Sirion introduced Zirgan to the US market earlier this year, making it the first new anti-viral therapy to be introduced in the US in more than 30 years, B+L said. In the US, Zirgan has been designated an orphan drug.


Technolas granted two foundation patents
Technolas Perfect Vision GmbH (Munich, Germany) has been issued two foundation patents for its technique for treating presbyopia by using a minimally invasive intrastromal laser procedure (dubbed INTRACOR) to reshape the cornea of the eye. The procedure was developed by Technolas in conjunction with Luis Antonio Ruiz, MD, a refractive surgeon from Colombia.
The surgical technique is already approved in Europe and select regions of Asia for the treatment of presbyopic hyperopes. Patients receiving the treatment have seen a dramatic increase in spectacle independence for reading and other daily activities, according to Technolas, a joint venture between Bausch + Lomb (Rochester, NY, USA) and 20/10 Perfect Vision AG (Heidelberg, Germany), the German femtosecond laser developer.


RP study drug yields improvement in visual function
A Phase II clinical study of patients with retinitis pigmentosa (RP) showed UF-021, a prostaglandin-related drug, improved visual function dose-dependently in both visual field test and subjective findings, co-developer Sucampo Pharmaceuticals (Bethesda, MD, USA) said in a press release. The company noted its partner, R-Tech Ueno (Japan), analyzed data from its Phase II study in 112 mid- to late-stage retinitis pigmentosa patients.
In April 2009, Sucampo licensed the development and commercialization rights to UF-021 for the US and Canada, including all associated patents, improvements, and other intellectual property owned, controlled and developed by R-Tech Ueno from the Japanese company.
Other findings from a multicenter, randomized, double-masked, three parallel group, placebo-controlled study included no severe adverse effects, although there was irritation upon instillation. Details of the study results are being submitted to upcoming conferences for presentation, Sucampo said in the release.
UF-021 is also known as Rescula (unoprostone isopropyl), a drug approved for the treatment of glaucoma.


PBA to host 'Swing Fore Sight' golf tournament
Prevent Blindness America is planning the 3rd Annual Swing Fore Sight Golf Tournament to be held in conjunction with Vision Expo West on 6 Oct. 2010, at the Bali Hai Golf Club in Las Vegas, NV, USA. The goal of the event is to raise US$130,000 to support the sight-saving programs of the foundation, according to an announcement from the organization.
Individual golfers may sign up for US$625 or foursomes for US$2,500. The tournament is a four-person scramble with awards being given for the low gross team, longest drive, closest to the pin, hole-in-one, and more.
For more information on the Prevent Blindness America 3rd Annual Swing Fore Sight Golf Tournament, contact Colleen Robbins at 312-363-6023 or [email protected].


Zylet revises pediatric indications
Bausch + Lomb (Rochester, NY, USA) recently revised its labeling for Zylet (loteprednol etabonate and tobramycin ophthalmic suspension, 0.5%/0.3%), a sterile, multiple-dose topical anti-inflammatory corticosteroid and antibiotic combination for ophthalmic use.
Per the original approval in 2004, the US Food and Drug Administration required post-marketing studies in the pediatric population, which B+L reported on in 2009.
The new pediatric use terminology (per the product's label) is as follows:
Pediatric Use: In a trial to evaluate the safety and efficacy of Zylet in pediatric patients age zero to six years with lid inflammation, Zylet with warm compresses did not demonstrate efficacy compared to vehicle with warm compresses. Patients received warm compress lid treatment plus Zylet or vehicle for 14 days. The majority of patients in both treatment groups showed reduced lid inflammation. There were no differences in safety assessments between treatment groups.


RESEARCH BRIEFS:
  • Bepotastine besilate ophthalmic solutions 1.0% and 1.5% both substantially decreased conjunctival allergen challenge (CAC)-induced ocular itching for at least eight hours after dosing, an article in press in the American Journal of Ophthalmology found. Thomas T. Macejkoa and colleagues found reductions in conjunctival hyperemia after a CAC, although statistically significant outcomes for bepotastine besilate ophthalmic solutions 1.0% and 1.5% compared with placebo when assessed at 15 minutes after dosing were modest. The group enrolled 130 subjects with a clinical history of allergic conjunctivitis who were randomized to bepotastine besilate ophthalmic solution 1.0%, 1.5% or 0.0% (placebo) in the prospective, double-masked, randomized, placebo-controlled, Phase III study. One drop of test agent was instilled bilaterally before a CAC test evaluating responses at 15 minutes, eight hours, or 16 hours after test agent instillation. Primary efficacy outcomes were unit improvements relative to placebo in mean scores for ocular itching and conjunctival hyperemia, each graded on 0- to 4-unit scales. Reductions of 1.2 units or more in mean ocular itching scores at all time points for both bepotastine besilate ophthalmic solutions 1.0% and 1.5% were observed at onset-of-action and eight-hour duration-of-action CAC tests (P<0.0001). Statistically significant reductions in conjunctival hyperemia (P<0.0125) were observed for bepotastine besilate ophthalmic formulations only at the onset-of-action CAC test.
  • Symptomatic dry eye was associated with difficulty in performing vision-dependent tasks, independent of visual acuity and other factors, according to L. Tong and colleagues at the Singapore National Eye Centre. The group conducted a population-based survey of eye diseases in 3,280 (78.7% response rate) Malay persons aged 40 years who were randomly selected from designated areas in southwestern Singapore. Participants were administered a standardized dry eye questionnaire consisting of six questions on symptoms and a questionnaire on vision-related daily activities. They also underwent comprehensive systemic and ocular examination. Symptomatic dry eye was defined as one or more self-reported symptoms that were frequently present (ranked as often or all the time). In adults without visual impairment, symptomatic dry eye after adjusting for age, gender, and presenting visual acuity was significantly associated with difficulty in vision-related activities such as navigating stairs, recognizing friends, reading road signs, reading the newspaper, watching television, cooking, and driving at night. The study is published in Eye.


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