At $182 a pop with royalties near 10% Triesence could be...

At $182 a pop with royalties near 10% Triesence could be significant earner for AOS thus killing the Singapore deal. News on this shouldn't be too far away. Thats about A$20 per pack. The benchmark is Kenalog so lets review what its sales are to help give us an idea of Trisence's potential.

Kenalog Net Sales Revenue (US Only)
June Qtr, 2007 USD 26m
Sept Qtr, 2007 USD 20m

So lets say annual net sales of about USD 80m. Assuming Triesence captures 50% of the market then this could mean US sales of at least USD 50m per annum. That would mean cash flow from royalties of around USD 5m every year to AOS (and this estimate is conservative). This would be worth a lot more than what they are getting for the total business from Oculus in Singapore. The deal is by no means a done yet imo.


It would seem that this expert thinks Triesence will become the norm. Read below:


From Eyeworld Magazine
COVER FEATURE presbyopia
Pharmaceutical Corner
In the news … steroids


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By Matt Young EyeWorld Contributing Editor

The latest ophthalmic steroids are by no means traditional

They don’t always come out of a tube, or need to be swallowed or injected. They’re not always even used for therapeutic purposes. From Triesence (triamcinolone acetonide injectable suspension, Alcon, Fort Worth, Texas),which is used for visualization purposes, to Retisert, an implant developed by Bausch & Lomb (Rochester, N.Y.) to release steroid gradually, this drug class is changing the way it operates.

Better than Kenalog?

In November 2007, the Food and Drug Administration (FDA) approved Triesence, a preservative-free synthetic corticosteroid particularly useful for visualization during vitrectomy. It also was approved to treat sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids.
For years, Triesence’s active ingredient, triamcinolone acetonide, has been used to treat retinal disease, but now it has another ophthalmic indication.
“It’s like Kenalog, but it has been approved for staining of the vitreous,” said Mark Packer, M.D., clinical associate professor, Casey Eye Institute, Oregon Health & Science University, Portland. Commercially available Kenalog (Bristol-Myers Squibb, New York) is manufactured specifically for intrabursal and intramuscular use, not for intravitreal use.
Dr. Packer said vitreous visualization is useful “anytime I have a broken capsule or broken zonules.”
He added, “I think now that the FDA has approved a version that is preservative-free, that will be safer in terms of TASS [toxic anterior segment syndrome] or other problems. I would think it would become standard of care rather than to use something off-label. I will switch to using it.”
Dr. Packer mentioned there also could be some off-label uses for Triesence, including cystoid macular edema (CME) and diabetic macular edema. Ophthalmologists conceivably could use Triesence for these conditions rather than a formulation with a preservative, Dr. Packer said.
Although Triesence hasn’t made it to Dr. Packer’s clinic quite yet, he said it probably will come with single-use packaging, which will improve infection prophylaxis.
“I think Triesence is a nice product,” said Francis S. Mah, M.D., co-medical director, Charles T. Campbell Ophthalmic Microbiology Laboratory, University of Pittsburgh School of Medicine. “The issue before was that Kenalog products available had preservatives, and we had to go through a lot of maneuvers to get rid of the preservatives. You had to filter it several times from one syringe to another syringe. You had to do that for every case, and correctly. Otherwise you would be injecting preservative into the eye.”
If ophthalmologists didn’t get rid of the preservatives, TASS or CME was certainly a potential repercussion, Dr. Mah said. He warned that glaucoma could still be an issue with Triesence use, as it could cause IOP spikes, Dr. Mah said.
Indeed, Dr. Packer said some ophthalmologists have suggested leaving steroids in the eye at the end of cataract surgery rather than using topical steroids post-op. That could lead to an elevated pressure situation, he said.
Other steroids
T-Pred, meanwhile, is ISTA Pharmaceuticals’ (Irvine, Calif.) fixed-combination medication in the pipeline. It combines the steroid prednisolone with tobramycin.
“ISTA took it one step further by putting these into an eye drop that mimics the composition of tears in an inflamed eye,” according to the company’s Fourth Quarter 2007 report. The company filed an NDA for T-Pred in June 2006 seeking approval “as a treatment for steroid-responsive inflammatory ocular conditions where risk of bacterial infection exists.
Although in May 2007, the FDA found that T-Pred was not approvable, ISTA has been in discussions with the administration to come to agreement on what must be done to receive approval. If eventually approved, T-Pred would compete with other combination drugs already in the market.
Dr. Mah said ISTA is also looking to develop a “strong steroid, multiple times stronger than prednisolone acetate.” The ISTA report acknowledged the development of a “strong steroid for ocular inflammation.”
“ISTA has completed a pilot study for its strong steroid eye drop and is continuing animal studies,” the report said. “Assuming timely completion and positive results, ISTA anticipates initiating Phase II studies in [the first half of 2008].”
Bausch & Lomb’s Retisert has been available for some time, FDA-approved in April 2005 to treat posterior uveitis. Anterior uveitis frequently can easily be treated with drops, but quelling posterior uveitis with drops, or other means, is much more difficult. The implant can deliver anti-inflammatory medication to the back of the eye for about 2.5 to 3 years.
“And after that period of time, the hope is that the eye inflammation will abate and the disease will burn itself out,” said Glenn Jaffe, M.D., Duke Eye Center, Durham, N.C. in a report by the center issued in 2005. Another implant can be used if the inflammation recurs.
Allergan is also pursuing an implant, called Posurdex, which releases corticosteroids to treat macular edema. It has shown promising results. “It was better than placebo,”
Despite hopes for approval for macular degeneration treatment, Retaane (Alcon) may have other significant uses, Dr. Mah noted. “I believe some research is being done because it seems to [impact incidence of] glaucoma,” Dr. Mah said. “One of the side effects or benefits is lower IOP. In clinical trials researchers found there was a pressure drop.” Dr. Mah said researchers now are looking at optimal dosage, frequency and mechanism of usage with the drug for lowering IOP.

Editors’ note: Dr. Packer has no financial interests related to his comments. Dr. Mah has financial interests with Alcon (Fort Worth, Texas), Allergan (Irvine, Calif.), and ISTA (Irvine, Calif.).