Novartis eye drug succeeds in Phase III trial
pharmafile | August 16, 2012 | News story | Sales and Marketing | FDA, Novartis, Ocriplasmin, Roche, VMA
Novartis has posted positive results for its investigational eye drug ocriplasmin.
The Phase III study found that ocriplasmin significantly resolved vitreomacular traction and closed macular holes compared to placebo, in patients with vitreomacular adhesion.
Vitreomacular adhesion (VMA), including vitreomacular traction (VMT) and macular holes, is an age-related progressive, debilitating eye disease that affects 300,000 patients in Europe – surgery is currently the only treatment option for the disease.
The two late-stage studies showed that after 28 days, following a single administration of ocriplasmin, resolution of VMA was observed in 26.5% of patients, compared to 10.1% in the placebo group.
This statistically significant difference was maintained through six months of observation, Novartis said.
By the end of the six months observation period, fewer patients required a vitrectomy [surgery in the affected area] in the ocriplasmin treated group, compared to placebo (17.7% versus 26.6 per cent).
“The data from these studies provide a basis for worldwide regulatory filings,” said Kevin Buehler, division head at Alcon.
“With Alcon’s extensive commercial capabilities, geographic footprint and strong relationships with retinal specialists and ophthalmologists, we are well positioned to bring this innovative treatment to patients outside the US, [if] it is approved.”
The firms expect to launch the drug in the US by the end of the year after a positive opinion by an FDA committee – the drug is currently under review by the EMA for approval in Europe.
Analysts Jeffries International forecast the drug could hit peak sales of $600 million – but this forecast doesn’t include additional indications for the drug currently being tested in diabetic retinopathy (DR), age-related macular degeneration (AMD) and stroke.
If approved this drug will build on Novartis’ ophthalmic offerings that include its blockbuster eye drug Lucentis (ranibizumab), which is licensed to treat wet AMD, retinal vein occlusion and diabetic macular oedema, and made $1.2 billion in sales last year.
Partnership
Novartis and partner ThromboGenics published the results in the New England Journal of Medicine this week. The Swiss firm signed a deal with ThromboGenics earlier this year through its ophthalmology unit Alcon.
The deal, worth $500 million, sees ThromboGenics retain rights to the drug in the US, whilst Novartis will sell the treatment in Europe, if approved.
ThromboGenics is also developing novel antibody therapeutics in collaboration with BioInvent International.
These include TB-402 (anti-Factor VIII), a long-acting anticoagulant in Phase II, and TB-403 (anti-PlGF) in Phase Ib/II for cancer in partnership with Roche.
Ben Adams
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