SUBSPECIALTY NEWS

‘Treat and Extend’ Program Reduces Injections and Costs

A Canadian Lucentis study shows major benefits.

■ A treat-and-extend protocol using injections of Lucentis (ranibizumab, Genentech, South San Francisco, CA) delivered significant benefits in terms of improved vision, fewer office visits and injections, and cost-effectiveness, according to findings presented at ARVO 2014 last month in Orlando, FL.

The investigators, led by Yufeng (Nancy) Chen, MD, of the Schulich School of Medicine and Dentistry in London, Ontario, conducted a retrospective, comprehensive review of a multicenter Canadian “Treat and Extend” program. They reviewed 332 treatment-naïve wet AMD patients who started Lucentis injections over 18 months ending in June 2012, including 78 patients already in the extension phase for more than nine months.

Patients on treat-and-extend (TER) were initially inducted with monthly injections until there was no evidence of active disease. They then moved to the phase when their treatment intervals were extended. Change in visual acuity and central retinal thickness (CRT) during induction and extension phases were recorded.

Patients on TER gained an average of 8.7 letters of vision during induction, and had a reduction on average of 86.4 µm of fluid on CRT. Researchers found that the worse the baseline vision, the greater the vision gained during induction. The average vision and CRT at baseline were 20/79 and 338 µm, respectively, while the average vision and CRT at first TER were 20/52 and 252 µm.

GAINS DURING THE ‘EXTEND’ PHASE

Both change in vision and in CRT were significant. During extension, patients on average gained an additional 2.3 letters (last TER vision 20/48), and had an additional decrease in CRT of 8.2 µm (last TER CRT 242 µm). While the gain in vision during extension was significant, the additional decrease in CRT was not.

Overall, on average, patients extended to 47.1 days between injections and received 8.2 injections per year. About 70.5% successfully maintained intervals greater than six weeks with on average 7.1 injections. Twenty-two percent successfully maintained intervals greater than eight weeks with an average 5.8 injections. The more injections the patients received prior to extension, the less likely they were to extend beyond six-weeks intervals.

Cost analysis estimated $20, 614 to treat one patient per year on monthly injections, while it would cost $14, 256 in TER year 1, with a projected cost of $13, 382 in TER year 2.

The researchers concluded that TER allows similar visual outcomes to monthly dosing, while reducing the total number of injections, visits, and overall cost. Patients not only maintained the outcomes they gained during monthly treatment, but gained vision when extended.

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Novartis Acquires International Rights to Fovista

Ophthotech licenses anti-PDGF drug now in phase 3.

■ Novartis, the Swiss company that already owns the international rights to the leading anti-VEGF drug Lucentis (ranibizumab, Genentech, South San Francisco, CA), has acquired the international rights to the anti-PDGF drug Fovista from Ophthotech (New York, NY). The licensing deal includes an up-front payment of $200 million to Ophthotech and future milestone and royalty payments that have the potential to exceed $1 billion. It also gives Ophthotech a major partner that can bring its expertise to advancing the development of combination therapies to treat retinal disease.

Fovista, an aptamer currently in three large-scale phase 3 trials, is designed to prevent platelet-derived growth factor (PDGF ) from binding to its natural receptor on pericytes, thus causing pericytes to be stripped from newly formed abnormal blood vessels. Left unprotected, the endothelial cells are highly vulnerable to the effects of anti-VEGF drugs.

Fovista is several years away from commercialization, but has delivered excellent results in its earlier trials. In a phase 2b study of 449 patients, a combination of Fovista and ranibizumab, each delivered by separate intravitreal injection, produced significantly greater vision gains at 24 weeks than ranibizumab monotherapy. The combination achieved a mean gain of 10.6 letters, while ranibizumab monotherapy demonstrated a mean increase of 6.5 letters. Novartis says it is developing a proprietary coformulation of Fovista and ranibizumab that can be delivered in a single injection. If Novartis can deliver on coformulating the two drugs, it would overcome a major hurdle that has constituted a challenge for Ophthotech.

Ophthotech will continue to lead the global Fovista phase 3 wet AMD pivotal clinical program, which is expected to have initial, topline data available in 2016

Treatment of Combat-related Retinal Detachment

Blast injuries made effective treatment difficult.

■ Doctors at Walter Reed National Military Medical Center, Washington, DC, conducted a retrospective study of 80 patients (82 eyes) who had traumatic retinal detachment in Iraq between 2002 and 2010 and were treated at Walter Reed. Interventions included pars plana vitrectomy, scleral buckle, observation, and additional surgical procedures as the clinical situation dictated.

The researchers, who presented their findings at ARVO 2014 last month in Orlando, FL, noted that the patients in the study tended to have perforating or penetrating (blast) trauma associated with the retinal detachment, unlike in the civilian sector where traumatic retinal detachment tends to be caused by blunt force.

Outcomes included 10% of eyes restored to 20/40 final visual acuity or better; 15% between 20/40 and 20/200; 11% between 19/200 and 1/200; 34% at hand motion or light perception; and 29% with final visual acuity of no light perception. Sixty-three percent of the study eyes had a perforating, penetrating or foreign-body injury. The final attachment rate was 67%, with 37% of eyes requiring a second surgery and 5% of eyes requiring three or more surgeries.

The researchers concluded that the nature of the injuries (open globe, loss of retinal tissue) and the lack of availability of specialized care in the combat theater were limitations that led to a lower final visual acuity and anatomic reattachment rate than typically reported in the civilian literature.

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