At Press Time

Alcon, OPKO Focus on Dry Eye

Both Companies License Investigational Drugs.

By Jerry Helzner, Senior Editor

■ With an estimated 30 to 40 million Americans experiencing at least some symptoms of dry eye and only one approved drug for this condition, both eyecare giant Alcon and aggressive newcomer OPKO Health are planning to enter this large market with recently licensed investigational dry eye drugs.

Alcon recently signed a licensing agreement with Lantibio, Inc. and TRB Chemedica for the U.S. development, marketing and manufacture of a product for the treatment of dry eye. The product is a patented formulation containing sodium hyaluronate and is currently being studied in the United States in an ongoing multicenter phase 3 pivotal study.

Lantibio will conduct the development program and filing of the NDA, while Alcon will assume responsibility for subsequent marketing, sales and manufacturing for the U.S. market.

Meanwhile, OPKO Health, Inc. has acquired exclusive worldwide rights from Winston Labs for ophthalmic use of a topical clinical stage compound with potential utility in the treatment of dry eye.

"There is only one approved prescription product currently available for dry eye (Restasis, Allergan), and we look forward to moving quickly to develop this product as a new and potentially better treatment option that can easily be administered as a nasal spray," says Sam Reich, Ph.D., executive vice president of ophthalmologics at OPKO.

The compound, civamide, a proprietary TRPV-1 receptor modulator and neuronal calcium channel blocker, is in phase 3 clinical trials in an intranasal formulation to treat various types of pain, including migraine headache. Increased tear production was observed in more than 50% of the patients receiving civamide and no systemic side effects were noted. Preliminary evidence suggests that civamide's effects on tear production result from its ability to modify signal transduction pathways present in the human lacrimal gland.

"Acquiring rights to this late-stage drug candidate reflects our strategy of proactively seeking new products and businesses to help fuel growth at OPKO," said Phillip Frost, M.D., chairman and CEO of OPKO Health. "This late stage, topically administered compound with demonstrated safety has the potential to reach the market relatively quickly. It addresses a significant unmet need which creates a sizeable opportunity."

OPKO Health was formed this year by Dr. Frost, a Miami billionaire known as the founder of two major drug companies, Key Pharmaceutical and IVAX. OPKO now encompasses the former Acuity Pharmaceuticals, which developed a wet AMD therapy based on Small Interfering RNA (SIRNA) molecules. This drug, bevasiranib sodium, is in a phase 3 clinical trial and is designed to be used to maintain vision after initial treatment with an anti-VEGF therapy.

OPKO is also involved in ophthalmic imaging with a new optical coherence tomography product. In addition, the company recently acquired a wound-sealing device to prevent endophthalmitis associated with retinal procedures.

IN THE NEWS
■ Glaucoma drug approved. Allergan, Inc. announced that the FDA has approved Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%, an alpha adrenergic receptor agonist with a beta adrenergic receptor inhibitor, for the reduction of elevated IOP in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP. ■ Once-a-day Xibrom. ISTA Pharmaceuticals, Inc. presented positive results from the company's two phase 3 clinical trials of Xibrom (bromfenac sodium ophthalmic solution) QD formulation, a new once-daily formulation of ISTA's ocular NSAID. The studies evaluated the new formulation vs. placebo in over 500 patients who underwent cataract surgery. The statistically significant findings demonstrated Xibrom QD was superior to placebo in achieving both the primary efficacy endpoint of absence of ocular inflammation 15 days following surgery and the secondary efficacy endpoint of elimination of ocular pain at day 1. In addition, compared to placebo, bromfenac produced a lower overall incidence of ocular adverse events. ■ Advance in patient consent. Patient consent for ophthalmic procedures goes in a new direction with the introduction of 3D-Eye Consent by Eyemaginations. Designed specifically for ophthalmologists and their patients, 3D-Eye Consent advances the informed consent process with software featuring Eyemaginations' animation. 3D-Eye Consent is built around an individual session in which the patient watches a series of animated videos that explain the condition, the recommended procedure, alternatives to the procedure, possible complications and other information critical to their consent. Each session is customized for the patient's specific visual condition and recommended treatment. At the conclusion of the session, the patient is required to answer questions about what they watched during the session to demonstrate their understanding. The final step requires their signature of consent. All information during the session is recorded in a database, which is accessible at any time. Currently, modules available for 3D-Eye Consent include LASIK, PRK and cataract surgery. Other modules will be introduced in the coming months. ■ New anti-infective. Vistakon Pharmaceuticals, LLC, has announced the introduction of Iquix (levofloxacin ophthalmic solution) 1.5% ocular anti-infective medication. Iquix is currently the only next-generation fluoroquinolone approved by the FDA for the treatment of corneal ulcers. Vistakon says Iquix rapidly penetrates corneal tissue and provides broad coverage of the most sight-threatening gram-negative and most prevalent gram-positive pathogens. "The introduction of Iquix marks a milestone in the treatment of corneal ulcers," says Penny A. Asbell, M.D., professor of ophthalmology, director of Cornea Services, External Disease and Refractive Surgery, Mount Sinai School of Medicine in New York. "Compared to existing ophthalmic fluoroquinolones, Iquix offers a higher sustained concentration option. This, paired with its dual mechanism of action, provides a new and important option for doctors' corneal ulcer treatment." ■ AAO calls for glaucoma policy. The American Academy of Ophthalmology (AAO) has called on the federal government to develop a unified standard for glaucoma screening and detection to help ensure patient access to appropriate and effective care. The AAO points out that in 2005 the U.S. Preventive Services Task Force (USPTF) concluded that there was insufficient scientific evidence to support the continued practice of screening for glaucoma. The finding is at odds with current medical practice and with current public policy, including those of multiple federal agencies, such as the National Institutes of Health, the Centers for Disease Control and Prevention, and the Centers for Medicare and Medicaid Services. "The inconsistency between the USPTF finding and current practice has the potential to threaten the access of patients with private insurance to detection of and treatment for glaucoma," said C.P. Wilkinson, M.D., president of the Academy. "It is critical that we revisit the scientific issues in order to resolve the contradiction in policies and protect the vision of patients." ■ Genentech limits Avastin sales. Genentech has agreed to continue sales of Avastin to compounding pharmacies until the end of this year. Earlier, Genentech had created deep concerns in the retina community by announcing that it would end all Avastin sales to compounding pharmacies as of Nov. 30. Many retina specialists have been using the cancer drug Avastin instead of Genentech's FDA-approved Lucentis to treat wet AMD, especially for patients who are not on Medicare or who do not have health insurance. Avastin, an anti-VEGF agent that is closely related to Lucentis, becomes a relatively inexpensive therapy (approximately $50 to $100 an injection) when repackaged by a compounding pharmacy in the small amounts required for ophthalmic use. Genentech said the FDA has expressed concerns about the repackaging of Avastin for ophthalmic use, noting that repackaging an already sterile drug is not consistent with the role of compounding pharmacies. An FDA inspection also led Genentech to destroy 350,000 vials of Avastin that were deemed unsuitable for ophthalmic use but suitable for the drug's FDA-approved cancer indication. Genentech said it would reinstate sales to compounders if the FDA gave it "legal and regulatory authorization" to do so, a hint that the FDA is the key to resolving the Avastin issue. OM

IN THE NEWS

■ Glaucoma drug approved.
Allergan, Inc. announced that the FDA has approved Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%, an alpha adrenergic receptor agonist with a beta adrenergic receptor inhibitor, for the reduction of elevated IOP in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP.
■ Once-a-day Xibrom. ISTA Pharmaceuticals, Inc. presented positive results from the company's two phase 3 clinical trials of Xibrom (bromfenac sodium ophthalmic solution) QD formulation, a new once-daily formulation of ISTA's ocular NSAID. The studies evaluated the new formulation vs. placebo in over 500 patients who underwent cataract surgery. The statistically significant findings demonstrated Xibrom QD was superior to placebo in achieving both the primary efficacy endpoint of absence of ocular inflammation 15 days following surgery and the secondary efficacy endpoint of elimination of ocular pain at day 1. In addition, compared to placebo, bromfenac produced a lower overall incidence of ocular adverse events.
■ Advance in patient consent. Patient consent for ophthalmic procedures goes in a new direction with the introduction of 3D-Eye Consent by Eyemaginations. Designed specifically for ophthalmologists and their patients, 3D-Eye Consent advances the informed consent process with software featuring Eyemaginations' animation.
3D-Eye Consent is built around an individual session in which the patient watches a series of animated videos that explain the condition, the recommended procedure, alternatives to the procedure, possible complications and other information critical to their consent. Each session is customized for the patient's specific visual condition and recommended treatment. At the conclusion of the session, the patient is required to answer questions about what they watched during the session to demonstrate their understanding. The final step requires their signature of consent. All information during the session is recorded in a database, which is accessible at any time.
Currently, modules available for 3D-Eye Consent include LASIK, PRK and cataract surgery. Other modules will be introduced in the coming months.
■ New anti-infective. Vistakon Pharmaceuticals, LLC, has announced the introduction of Iquix (levofloxacin ophthalmic solution) 1.5% ocular anti-infective medication. Iquix is currently the only next-generation fluoroquinolone approved by the FDA for the treatment of corneal ulcers. Vistakon says Iquix rapidly penetrates corneal tissue and provides broad coverage of the most sight-threatening gram-negative and most prevalent gram-positive pathogens.
"The introduction of Iquix marks a milestone in the treatment of corneal ulcers," says Penny A. Asbell, M.D., professor of ophthalmology, director of Cornea Services, External Disease and Refractive Surgery, Mount Sinai School of Medicine in New York. "Compared to existing ophthalmic fluoroquinolones, Iquix offers a higher sustained concentration option. This, paired with its dual mechanism of action, provides a new and important option for doctors' corneal ulcer treatment."
■ AAO calls for glaucoma policy. The American Academy of Ophthalmology (AAO) has called on the federal government to develop a unified standard for glaucoma screening and detection to help ensure patient access to appropriate and effective care.
The AAO points out that in 2005 the U.S. Preventive Services Task Force (USPTF) concluded that there was insufficient scientific evidence to support the continued practice of screening for glaucoma. The finding is at odds with current medical practice and with current public policy, including those of multiple federal agencies, such as the National Institutes of Health, the Centers for Disease Control and Prevention, and the Centers for Medicare and Medicaid Services.
"The inconsistency between the USPTF finding and current practice has the potential to threaten the access of patients with private insurance to detection of and treatment for glaucoma," said C.P. Wilkinson, M.D., president of the Academy. "It is critical that we revisit the scientific issues in order to resolve the contradiction in policies and protect the vision of patients."
■ Genentech limits Avastin sales.
Genentech has agreed to continue sales of Avastin to compounding pharmacies until the end of this year. Earlier, Genentech had created deep concerns in the retina community by announcing that it would end all Avastin sales to compounding pharmacies as of Nov. 30. Many retina specialists have been using the cancer drug Avastin instead of Genentech's FDA-approved Lucentis to treat wet AMD, especially for patients who are not on Medicare or who do not have health insurance.
Avastin, an anti-VEGF agent that is closely related to Lucentis, becomes a relatively inexpensive therapy (approximately $50 to $100 an injection) when repackaged by a compounding pharmacy in the small amounts required for ophthalmic use.
Genentech said the FDA has expressed concerns about the repackaging of Avastin for ophthalmic use, noting that repackaging an already sterile drug is not consistent with the role of compounding pharmacies.
An FDA inspection also led Genentech to destroy 350,000 vials of Avastin that were deemed unsuitable for ophthalmic use but suitable for the drug's FDA-approved cancer indication.
Genentech said it would reinstate sales to compounders if the FDA gave it "legal and regulatory authorization" to do so, a hint that the FDA is the key to resolving the Avastin issue. OM

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At Press Time

Alcon, OPKO Focus on Dry Eye

Both Companies License Investigational Drugs.

By Jerry Helzner, Senior Editor

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Alcon, OPKO Focus on Dry Eye

Both Companies License Investigational Drugs.

By Jerry Helzner, Senior Editor

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