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IVERIC Hits New 52-Week High, Stock Up 690% In 2 Months

ivericbio dec23 lt

Shares of IVERIC bio Inc. (ISEE), formerly Ophthotech Corp., have climbed more than 690% in just two months, thanks to the encouraging Zimura clinical trial results in geographic atrophy secondary to dry age-related macular degeneration.

Zimura, a complement 5 (C5) inhibitor, is also being developed for the treatment of Stargardt disease, an inherited form of juvenile macular dystrophy that causes sight loss.

Complement factor C5 is believed to be involved in the development of age-related macular degeneration and Stargardt disease.

Zimura is designed to target and inhibit the cleavage of complement protein C5 and the formation of the terminal fragments, C5a and C5b. By inhibiting the formation of complement system terminal fragments, Zimura may decrease the activation of inflammasomes and decrease the formation of MAC (membrane attack complex), thereby potentially avoiding or slowing the degeneration of RPE (retinal pigment epithelial) cells and providing the rationale as a potential therapy for both geographic atrophy and Stargardt disease, according to the Company.

On October 28, 2019, the Company reported positive results from a pivotal phase 2b trial of Zimura demonstrating a reduction in the rate of geographic atrophy growth in patients with dry age-related macular degeneration. The trial met the primary endpoint wherein the reduction in the mean rate of geographic atrophy growth over a period of over 12 months was about 27% with the intravitreal injections of Zimura 2mg and Zimura 4mg dose.

Age-related macular degeneration, or AMD, is a leading cause of vision loss in people over the age of 50 and older. There are two types of AMD - dry and wet.

Dry AMD is reported to account for 85% to 90% of all AMD cases. While there are various anti-VEGF treatment options available for wet AMD, which represents approximately 10% to 15% of AMD cases, there are currently no FDA or European Medicines Agency approved treatment options for patients with dry AMD or geographic atrophy, which is the advanced stage of dry AMD.

The second pivotal trial of Zimura for the treatment of geographic atrophy secondary to dry age-related macular degeneration is expected to be initiated in the first quarter of 2020.

As mentioned above, Zimura's potential is also being explored in treating Stargardt disease, and a phase IIb trial in this indication is underway. Top-line (18 month) data from this study is anticipated in the second half of next year.

The Company also has the following gene therapy candidates, all of which are preclinal testing or early stage of research…

-- IC-100, which is expected to enter phase I/II clinical trial in patients with Rhodopsin-Mediated Autosomal Dominant Retinitis Pigmentosa (RHO-adRP) in the second half of 2020.
-- IC-200, which is expected to enter a phase I/II clinical trial in patients with BEST1 related retinal diseases during the first half of 2021.
-- miniCEP290 for Leber Congenital Amaurosis Type 10 (LCA10), miniABCA4 Program for Stargardt Disease, miniUSH2A for the treatment of USH2A-related inherited retinal diseases, which are in early stage of research.

As of September 30, 2019, the Company had $94.9 million in cash and cash equivalents, and the year-end 2019 cash and cash equivalents are estimated to range between $80 million and $85 million.

IVERIC bio, which has a diversified, retina-focused portfolio, including both a late-stage clinical program for a large market retinal disease and early-stage gene therapy programs in inherited retinal diseases, has caught the attention of investors, as can be seen from the Company's stock performance.

ISEE has traded in a range of $0.91 to $8.18 in the last 1 year. The new high of $8.18 was recorded in intraday trading on Friday (Dec.20) before closing at $7.52, up 6.36%.

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