Survival through the Food and Drug Administration (FDA) approval process is tedious, costly and time consuming. Ophthalmic device and drug manufacturers make every effort to reach the market first with innovative, groundbreaking products in hopes of gaining a competitive edge of market share. They are challenged with producing quality evidence to substantiate that their product is like no other on the market and serves purpose to an ailing community.
The following brief descriptions highlight promising drugs and devices under study. These products are continuing through the regulatory processes necessary to achieve FDA market approval.
Agouron Pharmaceuticals Inc.s (La Jolla, Calif.) anti-angiogenesis drug AG3340 is in phase 2 clinical trials to evaluate the drugs safety and efficacy in patients with age-related macular degeneration (AMD). AG3340 is an orally active, synthetic molecule designed to inactivate specific enzymes called the matrix metalloproteases.
The safety trial includes approximately 100 patients aged 50 years and older who are affected by the neovascular form of AMD. The trial will determine the safety of the drug as well as the optimal dose and regimen to use in subsequent phase 3 trials. The effects of AG3340 on visual function and on neovascular lesions will be evaluated.
Implantable Contact Lens
STAAR Surgical Co.s (Monrovia, Calif.) Implantable Contact Lens (ICL) is in phase 3 clinical trials for myopia. Last fall, STAAR received approval from the FDA to expand its trials for hyperopia. With the expansion for hyperopia and the approval to start phase 3 trials for myopia, STAAR can enroll a total of 350 patients and include patients with refractive errors from 3 D to 20 D in each study.
The refractive procedure with the ICL leaves the cornea intact. A lens made of biocompatible material is implanted on the natural lens of the eye under the iris. The patients crystalline lens is left unchanged. The surgery can be performed on an outpatient basis, with quick correction of vision problems. According to STAAR Surgical, the method is virtually painless and the procedure is reversible.
Allergan Inc.s (Irvine, Calif.) Restasis (cyclosporine) is in phase 3 for the treatment of dry eye. Cyclosporine is a potent immunomodulator, used systemically to prevent organ transplant rejection. According to researchers, there are no approved indications for use of cyclosporine in the human eye as yet, but some physicians have used it because of its anti-inflammatory effect on ocular surface disease demonstrated in clinical trials. Additionally, cyclosporine has been used by some for treating ocular allergies. Researchers say that the agents approved use for treating dry eye in dogs is what prompted the human studies.
Oculex Pharmaceuticals Inc.s (Sunnyvale, Calif.) Surodex (dexamethasone) is in phase 3 clinical trials for the treatment of inflammation after cataract surgery. Surodex is made of biodegradable polymers containing dexamethasone. It is placed in the anterior chamber following cataract surgery to provide controlled release of dexamethasone at therapeutic, nonfluctuating levels into the interior of the eye. The agent can reduce postsurgical inflammation within days, rather than the weeks it takes eye drops. In clinical trials, patients experienced a significant reduction in inflammation by the fourth day after surgery.
Chemically named verteporfin, Visudyne (verteporfin) therapy is a potential treatment for severe forms of wet AMD. Verteporfin, a photosensitive compound, is injected intravenously and activated by the nonthermal laser as part of an up-and-coming technology termed photodynamic therapy. The outpatient process takes about 20 minutes and is rather painless. The abnormal blood vessels of wet AMD quickly absorb verteporfin. The nonthermal laser light is directed on the eye for about 90 seconds. When the laser light penetrates the treatment area, verteporfin produces an active form of oxygen that destroys the abnormal blood vessels and stops leakage.
QLT PhotoTherapeutics Inc. (Vancouver, British Columbia) and Ciba Vision Corp. (Duluth, Ga.), partners in developing Visudyne therapy, initiated the Treatment of Age-related macular degeneration with Photodynamic therapy study (TAP), which is made up of two international phase 3 clinical trials using Visudyne therapy as a potential treatment for wet AMD. The study remains ongoing to determine longer-term efficacy and safety. The two randomized, double-masked, placebo-controlled trials involve 609 patients at 22 centers in North America and Europe.
Results of the TAP investigation showed that patients treated with Visudyne therapy were more likely to have stable vision (defined as a loss of less than three lines of vision on a standard eye chart) or improved vision compared to placebo-treated patients at 12-month follow-up. These results were found to be statistically significant for each of the two studies, as well as for the combined data (p=.0002). Based on these results, both companies expect to file for approval in the United States, Canada and Europe this year. The companies anticipate that the therapy may be available sometime in 2000, pending regulatory approvals.
Vitrase is an injectable drug designed to induce the clearing of vitreous hemorrhage in less time than is normally required for clearing to occur on its own so the surgeon can treat the underlying problem. The drug has entered two phase 3 randomized, double-masked studies that will enroll 500 patients in three study groups in the United States and the same number and study groups in Europe. The three groups will each receive one of three different doses of Vitrase: 7.5 IU, 55 IU and 75 IU administered in single 50-µL intravitreal injections. A third study will be carried out comparing the 75-IU dose and an observational group to assess the natural clearing rate vs. Vitrase-treated eyes.
According to Advanced Corneal Systems Inc. (Irvine, Calif.), the developer of Vitrase, results from two phase 2 studies showed a significant improvement in the incidence of vitreous hemorrhage clearance occurring in the 75-IU dose compared with the 7.5-IU dose. All of the dose levels were well tolerated and there were no serious treatment-related adverse events reported.
For Your Information:
- Agouron Pharmaceuticals Inc. can be reached at 10350 N. Torrey Pines Road, Ste. 100, La Jolla, CA 92037-1020; (619) 622-3000; fax: (619) 622-3298.
- STAAR Surgical Co. can be reached at 1911 Walker Ave., Monrovia, CA 91016; (626) 303-7902; fax: (626) 303-2962.
- Allergan Inc. can be reached at 2525 Dupont Drive, P.O. Box 19534, Irvine, CA 92623-9534; (714) 246-4500; fax: (714) 246-4162.
- Oculex Pharmaceuticals Inc. can be reached at 639 N. Pastoria Ave., Sunnyvale, CA 94086; (408) 481-0424; fax: (408) 481-0662.
- QLT Photo Therapeutics Inc. can be reached at 520 W. Sixth Ave., Vancouver, British Columbia V5H 4H5; (604) 872-7881; fax: (604) 875-0001.
- Ciba Vision Corp. can be reached at 11460 Johns Creek Park way, Duluth, GA 30097-1556; (770) 418-4208; fax: (770) 418-4256.
- Advanced Corneal Systems Inc. can be reached at 15279 Alton Parkway, Ste. 100, Irvine, CA 92618; (949) 788-6000; fax: (949) 788-6010.
- Bausch & Lomb Surgical can be reached at 555 W. Arrow Highway, Claremont, CA 91711; (800) 423-1871; fax: (909) 399-1524.
- KeraVision Inc. can be reached at 48630 Milmont Drive, Fre mont, CA 94538-7353; (510) 353-3000; fax: (510) 353-3030.
- Ophthalmic Innovations International can be reached at 550 N. Claremont Blvd., Clare mont, CA 91711; (909) 626-4558; fax: (909) 626-7338.
- Sunrise Tech nologies International Inc. can be reached at 47265 Fremont Blvd., Fremont, CA 94538; (510) 623-9001; fax: (510) 623-9008.
- British Biotech Plc. can be reached at Watlington Road, Oxford, England OX4 5LY; (44) 186-5748747; fax: (44) 186-5781047.
- InSite Vision Inc. can be reached at 965 Atlantic Ave., Alameda, CA 94501; (510) 865-8800; fax: (510) 865-5700.
- Entre Med Inc. can be reached at 9610 Medical Center Drive, Ste. 200, Rockville, MD 20850; (301) 217-9858; fax: (301) 217-9594.
- Orphan Medical Inc. can be reached at 13911 Ridgedale Drive, Ste. 475, Minetonka, MN 55305; (612) 513-6900; fax: (612) 541-9209.
- Ophtec USA Inc. can be reached at 10304 Islander Drive, Boca Raton, FL 33498; (561) 989-8767; fax: (561) 989-9744.
- Paradigm Medical Industries Inc. can be reached at 1772 W. 2300 South, Salt Lake City, UT 84119; (810) 977-8970; fax: (810) 977-8973.
- Akorn Inc. can be reached at 100 Tri-State Drive, Building 100, Ste. 100, Lincolnshire, IL 60069-4404; (800) 535-7155; fax: (800) 943-3694.
- LaserSight Tech nol ogies Inc. can be reached at 12249 Science Drive, Ste. 160, Orlando, FL 32826; (407) 382-2700; fax: (312) 576-1073.
- Ligand Pharmaceuticals Inc. can be reached at 10275 Science Center Drive, San Diego, CA 92121; (619) 550-7500; fax: (619) 550-7506.
- Medarex Inc. can be reached at 1541 Route 22 East, Annadale, NJ 08801; (908) 713-6001; fax: (908) 713-6002.
- Miravant Medical Technologies can be reached at 7408 Hollister Ave., Santa Bar bara, CA 93117; (805) 685-9880; fax: (805) 685-2959.
- Pharmacia & Upjohn Co. can be reached at 95 Corporate Drive, Bridgewater, NJ 08807; (908) 306-4400; fax: (908) 306-4433.