ISEE IVERIC bio Inc.

5.1
-0.06  -1%
Previous Close 5.16
Open 5.25
52 Week Low 0.9059
52 Week High 8.97
Market Cap $451,286,607
Shares 88,487,570
Float 77,777,832
Enterprise Value $348,568,861
Volume 768,442
Av. Daily Volume 1,207,300
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Upcoming Catalysts

Drug Stage Catalyst Date
Zimura
Autosomal Recessive Stargardt Disease
Phase 2b
Phase 2b
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Drug Pipeline

Drug Stage Notes
Zimura - GATHER2
Geographic atrophy
Phase 3
Phase 3
Phase 3 trial met primary endpoint. Initiation of second trial announced June 30, 2020.
IC-200
BEST1 related retinal diseases
Phase 1/2
Phase 1/2
Phase 1/2 trial to be initiated 1H 2021.
IC-100
Rhodopsin-mediated autosomal dominant retinitis pigmentosa (RHO-adRP)
Phase 1/2
Phase 1/2
Phase 1/2 trial to be initiated 1H 2021.
Zimura
Wet age-related macular degeneration (Wet-AMD)
Phase 2a
Phase 2a
Phase 2a top-line data released November 12, 2018 noted that treatment was generally well tolerated.
Fovista
Wet age-related macular degeneration (Wet-AMD)
Phase 3
Phase 3
Phase 3 data released December 12, 2016 - primary endpoint not met. Data from third trial released August 14, 2017- primary endpoint not met.

Latest News

  1. IVERIC bio, Inc. (NASDAQ:ISEE) today announced the first patient has been dosed in GATHER2, also known as ISEE2008, the second Phase 3 clinical trial for Zimura® (avacincaptad pegol), a novel complement C5 inhibitor, in development for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The Company announced previously that Zimura met its pre-specified primary efficacy endpoint and reached statistical significance in GATHER1, also known as OPH2003, the first Phase 3 clinical trial for Zimura for the treatment of GA secondary to AMD. There are no U.S. Food and Drug Administration or European Medicines Agency approved treatments available for patients with GA secondary to AMD.

    "The absence of treatment…

    IVERIC bio, Inc. (NASDAQ:ISEE) today announced the first patient has been dosed in GATHER2, also known as ISEE2008, the second Phase 3 clinical trial for Zimura® (avacincaptad pegol), a novel complement C5 inhibitor, in development for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The Company announced previously that Zimura met its pre-specified primary efficacy endpoint and reached statistical significance in GATHER1, also known as OPH2003, the first Phase 3 clinical trial for Zimura for the treatment of GA secondary to AMD. There are no U.S. Food and Drug Administration or European Medicines Agency approved treatments available for patients with GA secondary to AMD.

    "The absence of treatment options for geographic atrophy represents an area of urgent unmet medical need and a major public health concern for the expanding aging population," stated Glenn P. Sblendorio, Chief Executive Officer and President of IVERIC bio. "The initiation of enrollment in GATHER2, brings us another step closer to potentially delivering a clinically meaningful therapy to patients with GA. The GATHER2 clinical trial, if positive, marks the second Phase 3 clinical trial needed to seek regulatory approval for Zimura."

    "We believe GATHER1 is currently the only Phase 3 clinical trial showing early suppression of GA growth which continued for 18 months with continuous treatment," stated Kourous A. Rezaei, M.D., Chief Medical Officer of IVERIC bio. "We have experienced impressive enthusiasm by our investigators to initiate the second Phase 3 trial, GATHER2, based on the robustness of efficacy, the strength of the statistical evidence, and the favorable safety profile of Zimura in the GATHER1 Phase 3 trial. We believe that these robust data increase comfort and confidence in our investigators to expedite recruitment and retain patients in our GATHER2 clinical trial."

    In the GATHER2 clinical trial, approximately 400 patients will be randomized to receive either monthly administration of Zimura 2 mg or sham during the first 12 months of the trial, at which time the primary efficacy analysis of the mean rate of change of GA growth at 12 months will be performed. If the 12 month results are positive, the Company plans to file an application with the U.S. Food and Drug Administration and the European Medicines Agency for marketing approval of Zimura for GA following receipt of that data. At month 12, the Company plans to re-randomize patients in the Zimura 2 mg arm to receive either monthly or every other month administration of Zimura 2 mg. The final evaluation will take place at month 24.

    Geographic Atrophy

    Age-related macular degeneration (AMD) is the major cause of moderate and severe loss of central vision in aging adults, affecting both eyes in the majority of patients. The macula is a small area in the central portion of the retina responsible for central vision. As AMD progresses, the loss of retinal cells and the underlying blood vessels in the macula results in marked thinning and/or atrophy of retinal tissue. Geographic atrophy, the advanced stage of AMD, leads to further irreversible loss of vision in these patients. There are currently no U.S. Food and Drug Administration (FDA) or European Medicines Agency (EMA) approved treatment options available for patients with geographic atrophy.

    Zimura

    Complement factor C5 is a central component of the complement cascade and is believed to be involved in the development and progression of AMD. Zimura is designed to inhibit complement factor C5 cleavage into C5a and C5b. By inhibiting the formation of complement C5 terminal fragments, Zimura may decrease the activation of inflammasomes and the formation of membrane attack complex (MAC). This mechanism of action could potentially prevent or slow down the degeneration of retinal pigment epithelial (RPE) cells and slow down the progression of GA.

    IVERIC bio

    IVERIC bio is a science-driven biopharmaceutical company focused on the discovery and development of novel treatment options for retinal diseases with significant unmet medical needs. The Company is currently developing both therapeutic product candidates for age-related retinal diseases and gene therapy product candidates for orphan inherited retinal diseases. Vision is Our Mission. For more information on the Company, please visit www.ivericbio.com.

    Forward-looking Statements

    Any statements in this press release about the Company's future expectations, plans and prospects constitute forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Forward-looking statements include any statements about the Company's strategy, future operations and future expectations and plans and prospects for the Company, and any other statements containing the words "anticipate," "believe," "estimate," "expect," "intend", "goal," "may", "might," "plan," "predict," "project," "seek," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions. In this press release, the Company's forward looking statements include statements about the impact of the COVID-19 pandemic on the Company's research and development programs, operations and financial position, its expectations to initiate enrollment in its second Phase 3 trial (GATHER2) of Zimura in geographic atrophy secondary to AMD and to use its previously announced clinical trial of Zimura for the treatment of geographic atrophy (GATHER1) as a Phase 3 trial, its development and regulatory strategy for Zimura, the potential clinical meaningfulness of the results of clinical trials, the Company's hypotheses regarding complement inhibition as a mechanism of action for the treatment of geographic atrophy, the implementation of its business plan, the timing, progress and results of clinical trials and other research and development activities and the potential utility of its product candidates. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company's development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, those related to the progression and duration of the COVID-19 pandemic and responsive measures thereto and related effects on the Company's research and development programs, operations and financial position, the initiation and the progress of research and development programs and clinical trials, availability of data from these programs, reliance on collaborators and other third parties, establishment of manufacturing capabilities, expectations for regulatory matters and need for additional financing and other factors discussed in the "Risk Factors" section contained in the quarterly and annual reports that the Company files with the Securities and Exchange Commission. Any forward-looking statements represent the Company's views only as of the date of this press release. The Company anticipates that subsequent events and developments will cause its views to change. While the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so except as required by law.

    ISEE-G

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  2. IVERIC bio, Inc. (NASDAQ:ISEE) (the "Company"), today announced the closing of its underwritten public offering of 28,503,220 shares of its common stock at a price to the public of $4.100 per share and, to certain investors in lieu of common stock, pre-funded warrants to purchase 1,914,280 shares of its common stock at a price to the public of $4.099 per pre-funded warrant, in each case, before underwriting discounts and commissions. The shares of common stock issued and sold in the public offering at the closing include 3,967,500 shares issued upon the exercise in full by the underwriters of their option to purchase additional shares at the public offering price, less the underwriting discount. All of the shares and warrants in the public…

    IVERIC bio, Inc. (NASDAQ:ISEE) (the "Company"), today announced the closing of its underwritten public offering of 28,503,220 shares of its common stock at a price to the public of $4.100 per share and, to certain investors in lieu of common stock, pre-funded warrants to purchase 1,914,280 shares of its common stock at a price to the public of $4.099 per pre-funded warrant, in each case, before underwriting discounts and commissions. The shares of common stock issued and sold in the public offering at the closing include 3,967,500 shares issued upon the exercise in full by the underwriters of their option to purchase additional shares at the public offering price, less the underwriting discount. All of the shares and warrants in the public offering were sold by the Company.

    In addition, the Company announced the closing of its concurrent private placement exempt from the registration requirements of the Securities Act of 1933, as amended (the "Securities Act"), of 8,649,453 shares of its common stock to affiliates of Vivo Capital, LLC and Samsara BioCapital, LP, at a sale price equal to the price to the public in the public offering.

    The Company received net proceeds of approximately $116.9 million from the public offering, after deducting underwriting discounts and commissions and estimated offering expenses, and approximately $33.1 million from the concurrent private placement, after deducting placement agent fees and estimated offering expenses.

    Cowen and Credit Suisse acted as book-running managers for the public offering and as the placement agents for the concurrent private placement. Wedbush PacGrow acted as lead manager for the public offering.

    The public offering was made only by means of a prospectus supplement and accompanying prospectus that form a part of an effective registration statement. A final prospectus supplement related to the public offering was filed with the Securities and Exchange Commission (the "SEC") and is available on the SEC's website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the public offering may also be obtained by contacting: Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, Attn: Prospectus Department, or by emailing , or by telephone: (833) 297-2926; or Credit Suisse Securities (USA) LLC, Attn: Prospectus Department, 6933 Louis Stephens Drive, Morrisville, North Carolina 27560, or by telephone: (800) 221-1037, or by emailing .

    The securities sold in the concurrent private placement have not been registered under the Securities Act, or any state or other applicable jurisdiction's securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions' securities laws.

    This press release does not constitute an offer to sell, or a solicitation of an offer to buy these securities, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    IVERIC bio

    IVERIC bio is a science-driven biopharmaceutical company focused on the discovery and development of novel treatment options for retinal diseases with significant unmet medical needs. The Company is currently developing both therapeutic product candidates for age-related retinal diseases and gene therapy product candidates for orphan inherited retinal diseases. Vision is Our Mission.

    ISEE-G

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  3. IVERIC bio, Inc. (NASDAQ:ISEE) (the "Company"), today announced the pricing of an upsized underwritten public offering of 24,535,720 shares of its common stock at a price to the public of $4.100 per share and, to certain investors in lieu of common stock, pre-funded warrants to purchase 1,914,280 shares of its common stock at a price to the public of $4.099 per pre-funded warrant, in each case less underwriting discounts and commissions. The purchase price of each pre-funded warrant represents the per share public offering price for the common stock, minus the $0.001 per share exercise price of such pre-funded warrant. In addition, in connection with the public offering, the Company has granted the underwriters an option for a period of 30…

    IVERIC bio, Inc. (NASDAQ:ISEE) (the "Company"), today announced the pricing of an upsized underwritten public offering of 24,535,720 shares of its common stock at a price to the public of $4.100 per share and, to certain investors in lieu of common stock, pre-funded warrants to purchase 1,914,280 shares of its common stock at a price to the public of $4.099 per pre-funded warrant, in each case less underwriting discounts and commissions. The purchase price of each pre-funded warrant represents the per share public offering price for the common stock, minus the $0.001 per share exercise price of such pre-funded warrant. In addition, in connection with the public offering, the Company has granted the underwriters an option for a period of 30 days to purchase up to an additional 3,967,500 shares of common stock at the public offering price, less underwriting discounts and commissions. All of the securities are being offered by the Company.

    Concurrent with the public offering, the Company has agreed to sell, subject to the consummation of the public offering and other customary conditions, in a private placement exempt from the registration requirements of the Securities Act of 1933, as amended (the "Securities Act"), 8,649,453 additional shares of its common stock to affiliates of Vivo Capital, LLC and Samsara BioCapital, LP, at a sale price equal to the price to the public in the public offering.

    The aggregate gross proceeds from the public offering and the concurrent private placement are expected to be approximately $143.9 million, before underwriting discounts and commissions, placement agent fees and offering expenses payable by the Company, and without giving effect to any exercise by the underwriters of their option to purchase additional shares.

    Cowen and Credit Suisse are acting as the book-running managers for the public offering and as placement agents for the concurrent private placement. Wedbush PacGrow is acting as lead manager for the public offering. The public offering and the concurrent private placement are expected to close on or about June 22, 2020, subject to customary closing conditions.

    The public offering is being made only by means of a prospectus supplement and accompanying prospectus that form a part of an effective registration statement. A final prospectus supplement related to the public offering will be filed with the Securities and Exchange Commission (the "SEC") and will be available on the SEC's website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the public offering may also be obtained, when available, by contacting: Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, Attn: Prospectus Department, or by emailing , or by telephone: (833) 297-2926; or Credit Suisse Securities (USA) LLC, Attn: Prospectus Department, 6933 Louis Stephens Drive, Morrisville, North Carolina 27560, or by telephone: (800) 221-1037, or by emailing .

    The securities to be sold in the concurrent private placement have not been registered under the Securities Act, or any state or other applicable jurisdiction's securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions' securities laws.

    This press release does not constitute an offer to sell, or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    IVERIC bio

    IVERIC bio is a science-driven biopharmaceutical company focused on the discovery and development of novel treatment options for retinal diseases with significant unmet medical needs. The Company is currently developing both therapeutic product candidates for age-related retinal diseases and gene therapy product candidates for orphan inherited retinal diseases. Vision is Our Mission.

    Forward-Looking Statements

    Any statements in this press release about the Company's future expectations, plans and prospects, including statements regarding the public offering and the concurrent private placement, constitute forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Forward-looking statements include any statements about the Company's strategy, future operations and future expectations and plans and prospects for the Company, and any other statements containing the words "anticipate," "believe," "estimate," "expect," "intend", "goal," "may", "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company's development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, those related to satisfaction of customary closing conditions related to the public offering and the concurrent private placement, the progression and duration of the novel coronavirus (COVID-19) pandemic and responsive measures thereto and related effects on the financial markets and the Company's research and development programs, operations and financial position, the initiation and the progress of research and development programs and clinical trials, availability of data from these programs, reliance on university collaborators and other third parties, establishment of manufacturing capabilities, expectations for regulatory matters, need for additional financing and negotiation and consummation of business development transactions, whether the Company's cash resources will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements on its expected timelines, and other factors discussed in the "Risk Factors" section contained in the preliminary prospectus supplement and the reports that the Company files with the SEC. Any forward-looking statements represent the Company's views only as of the date of this press release. The Company anticipates that subsequent events and developments will cause its views to change. While the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so except as required by law.

    ISEE-G

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  4. IVERIC bio, Inc. (NASDAQ:ISEE) (the "Company"), today announced that it is commencing an underwritten public offering of $50.0 million of shares of its common stock (or pre-funded warrants to purchase its common stock in lieu thereof). In addition, the Company intends to grant the underwriters an option for a period of 30 days to purchase up to an additional 15 percent of the number of shares of its common stock plus the shares of common stock underlying pre-funded warrants sold in connection with the public offering. The public offering is subject to market and other conditions, and there can be no assurance as to whether or when the public offering may be completed or as to the actual size or terms of the public offering. All of the shares…

    IVERIC bio, Inc. (NASDAQ:ISEE) (the "Company"), today announced that it is commencing an underwritten public offering of $50.0 million of shares of its common stock (or pre-funded warrants to purchase its common stock in lieu thereof). In addition, the Company intends to grant the underwriters an option for a period of 30 days to purchase up to an additional 15 percent of the number of shares of its common stock plus the shares of common stock underlying pre-funded warrants sold in connection with the public offering. The public offering is subject to market and other conditions, and there can be no assurance as to whether or when the public offering may be completed or as to the actual size or terms of the public offering. All of the shares are to be offered by the Company.

    Concurrent with the public offering, the Company has agreed to sell, subject to the consummation of the public offering and other customary conditions, in a private placement exempt from the registration requirements of the Securities Act of 1933, as amended (the "Securities Act"), $35 million of its common stock to affiliates of Vivo Capital, LLC and Samsara BioCapital, LP at a sale price equal to the price of the common stock sold to the public in the public offering. The consummation of the public offering is not contingent on the consummation of the concurrent private placement.

    Cowen and Credit Suisse are acting as the book-running managers for the public offering and as placement agents for the concurrent private placement. Wedbush PacGrow is acting as lead manager for the public offering.

    A shelf registration statement on Form S-3 (File No. 333-226497) relating to the shares of common stock to be offered in the public offering was filed with the Securities and Exchange Commission (the "SEC") and was declared effective on August 15, 2018. The public offering will be made only by means of a prospectus supplement and accompanying prospectus that form a part of the registration statement. A preliminary prospectus supplement related to the public offering is being filed with the SEC and will be available on the SEC's website at www.sec.gov. Copies of the preliminary prospectus supplement and accompanying prospectus relating to the public offering may also be obtained by contacting: Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, Attn: Prospectus Department, or by emailing , or by telephone: (833) 297-2926; or Credit Suisse Securities (USA) LLC, Attn: Prospectus Department, 6933 Louis Stephens Drive, Morrisville, North Carolina 27560, or by telephone: (800) 221-1037, or by emailing .

    The securities to be sold in the concurrent private placement have not been registered under the Securities Act, or any state or other applicable jurisdiction's securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions' securities laws.

    This press release does not constitute an offer to sell, or a solicitation of an offer to buy these securities, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    IVERIC bio

    IVERIC bio is a science-driven biopharmaceutical company focused on the discovery and development of novel treatment options for retinal diseases with significant unmet medical needs. The Company is currently developing both therapeutic product candidates for age-related retinal diseases and gene therapy product candidates for orphan inherited retinal diseases. Vision is Our Mission.

    Forward-Looking Statements

    Any statements in this press release about the Company's future expectations, plans and prospects, including statements regarding the proposed public offering and the concurrent private placement, constitute forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Forward-looking statements include any statements about the Company's strategy, future operations and future expectations and plans and prospects for the Company, and any other statements containing the words "anticipate," "believe," "estimate," "expect," "intend", "goal," "may", "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company's development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, those related to market and other financial conditions, the potential completion of the proposed public offering and the concurrent private placement or the size or terms thereof, satisfaction of customary closing conditions related to the proposed public offering and the concurrent private placement, the progression and duration of the novel coronavirus (COVID-19) pandemic and responsive measures thereto and related effects on the financial markets and the Company's research and development programs, operations and financial position, the initiation and the progress of research and development programs and clinical trials, availability of data from these programs, reliance on university collaborators and other third parties, establishment of manufacturing capabilities, expectations for regulatory matters, need for additional financing and negotiation and consummation of business development transactions, whether the Company's cash resources will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital requirements on its expected timelines, and other factors discussed in the "Risk Factors" section contained in the preliminary prospectus supplement and the reports that the Company files with the SEC. Any forward-looking statements represent the Company's views only as of the date of this press release. The Company anticipates that subsequent events and developments will cause its views to change. While the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so except as required by law.

    ISEE-G

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  5. NEW YORK, June 15, 2020 /PRNewswire/ -- IVERIC bio, Inc. (NASDAQ:ISEE) today announced positive 18 month results from the Company's first Phase 3 clinical trial (OPH2003) for Zimura® (avacincaptad pegol), a novel complement C5 inhibitor, for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The 18 month data supports the previously announced 12 month data from this trial, at which time point Zimura met the pre-specified primary efficacy endpoint with statistical significance. The reduction in the mean rate of GA growth over 18 months was 28.11% for the Zimura 2 mg group as compared to the corresponding sham control group and 29.97% for the Zimura 4 mg group as compared to the corresponding sham control…

    NEW YORK, June 15, 2020 /PRNewswire/ -- IVERIC bio, Inc. (NASDAQ:ISEE) today announced positive 18 month results from the Company's first Phase 3 clinical trial (OPH2003) for Zimura® (avacincaptad pegol), a novel complement C5 inhibitor, for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The 18 month data supports the previously announced 12 month data from this trial, at which time point Zimura met the pre-specified primary efficacy endpoint with statistical significance. The reduction in the mean rate of GA growth over 18 months was 28.11% for the Zimura 2 mg group as compared to the corresponding sham control group and 29.97% for the Zimura 4 mg group as compared to the corresponding sham control group. The pre-specified efficacy analysis for the primary endpoint was performed at month 12 using all of the power in the trial to detect a statistically significant difference. Therefore, the p-values for the 18 month statistical analyses are descriptive in nature. The descriptive p-values for the treatment effects at month 18 were p=0.0014 for the Zimura 2 mg group and p=0.0021 for the Zimura 4 mg group.



    In this trial, the treatment effect was observed as early as 6 months, with an increase in the absolute difference of the mean change in GA growth for treatment with either Zimura 2 mg or Zimura 4 mg, as compared to sham, at each subsequent time point, suggesting the progressive benefit of continuous treatment with Zimura. Zimura maintained its favorable safety profile at 18 months with no reported Zimura related adverse events, no cases of endophthalmitis and a lower rate of choroidal neovascularization (CNV) than reported for C3 inhibition. The overall 18 month data may suggest a dose response relationship. 



    "We are extremely excited by the new 18 month data from this Phase 3 clinical trial, both with respect to efficacy and safety," stated Glenn P. Sblendorio, Chief Executive Officer and President of IVERIC bio. "In the OPH2003 clinical trial, the 18 month results indicated continuous Zimura treatment benefit with a favorable safety profile in patients with GA secondary to AMD. This is an impressive achievement since we believe OPH2003 is currently the only Phase 3 clinical trial showing suppression of GA growth with continuous treatment for 18 months."



    "We are one step closer to potentially bringing a clinically meaningful therapy to patients with GA who currently do not have any FDA or EMA approved treatments available to them," stated Kourous A. Rezaei, MD, Chief Medical Officer of IVERIC bio. "We believe the robust 18 month efficacy data further validates the potential role of complement C5 inhibition in GA secondary to AMD and has the potential to differentiate Zimura from other product candidates in development. We are poised to initiate our second pivotal trial, ISEE2008, comparing Zimura 2 mg with sham later this month. We want to thank our patients, our clinical trial investigators and their staffs for their support and participation in this trial."



    The Company previously announced that in the OPH2003 clinical trial, Zimura met its pre-specified primary efficacy endpoint at 12 months and reached statistical significance in the international, multicenter, randomized, double masked, sham controlled clinical trial in GA secondary to AMD. The reduction in the mean rate of GA growth over 12 months was 27.38% (p-value = 0.0072) for the Zimura 2 mg group as compared to the corresponding sham control group and 27.81% (p-value = 0.0051) for the Zimura 4 mg group as compared to the corresponding sham control group. The data for both dose groups were statistically significant. 



    "I am excited about the efficacy and favorable safety profile observed in the 12 month Zimura Phase 3 data, and now the long term 18 month efficacy and safety data further confirm my belief in the role of complement C5 inhibition in the treatment of GA," stated Peter K. Kaiser, MD, Chaney Family Endowed Chair in Ophthalmology Research, Cole Eye Institute and Professor of Ophthalmology at the Cleveland Clinic Lerner College of Medicine. "The delta between the Zimura 2 mg and Zimura 4 mg treatment groups and the corresponding sham control groups occurred early in the study and continued over 18 months which means my patients may benefit after only a few injections and maintain this with additional treatments. Moreover, the safety profile remained favorable after 18 months of treatment."



    "We are excited by these 18 month results," stated Pravin U. Dugel, MD, Executive Vice President and Chief Strategy and Business Officer of IVERIC bio. "In the challenging COVID-19 pandemic era, we believe that we are in an advantageous position as the OPH2003 data is the only positive Phase 3 clinical data in GA secondary to AMD that we are aware of that has been reported to date. We believe that these robust data should increase investigator enthusiasm and confidence for patient recruitment and retention in our ISEE2008 clinical trial."



    OPH2003 18 Month Data



    A total of 286 patients were enrolled in this trial.



    Mean rate of change in GA growth over 18 months, was measured by fundus autofluorescence (FAF) based on readings at four time points (baseline, month 6, month 12 and month 18) and was calculated using the square root transformation of the GA area. The FAF images were assessed by an independent masked reading center. The prespecified statistical analysis plan used a model of repeated measures (MRM) to compare data for the Zimura 2 mg and Zimura 4 mg groups to the corresponding sham groups. Detailed data are shown below:

    Mean Rate of Change in Geographic Atrophy (GA) Area from Baseline to Month 18

    (Square Root Transformation)



    Cohort

    Zimura 2 mg

    (N = 67)

    Sham

    (N = 110)

    Difference

    % Difference

    P-Value

    (Descriptive)

    Mean Change in GAa (mm)

    0.430

    0.599

    0.168

    28.11%

    0.0014













    Cohort

    Zimura 4 mg

    (N = 83)

    Sham

    (N = 84)

    Difference

    % Difference

    P-Value

    (Descriptive)

    Mean Change in GAb (mm)

    0.391

    0.559

    0.167

    29.97%

    0.0021



    a Based on least squares means from MRM model, these least square means are from the MRM model, drawing on all available data at the month 18 time point, including data from groups with different randomization ratios in Part 1 and Part 2, and should not be interpreted as directly observed data.

    b These least squares means are estimates of the MRM model, drawing on all available data, at the month 18 time point.

    The graphs below illustrate the observed difference in mean rate of GA growth between each of the Zimura 2 mg and Zimura 4 mg treatment groups and their corresponding sham control groups based on the MRM analysis at both 12 months (which was previously reported) and 18 months. 

    ITT Population; Based on the least squares means from MRM Model drawing on all available data at the respective 12 month and 18 month analysis time points, including data from groups with different randomization ratios in Part 1 and Part 2, and should not be interpreted as directly observed data; Hochberg procedure used for significance testing for 12 month data. *Previously reported (PRNewsfoto/IVERIC bio, Inc.)

     

    ITT Population; Based on the least squares means from the MRM Model drawing on all available data at the respective 12 month and 18 month analysis time points; Hochberg procedure used for significance testing for 12 months data. *Previously reported (PRNewsfoto/IVERIC bio, Inc.)

    Zimura was generally well tolerated after 18 months of administration. There was no Zimura-related inflammation, no Zimura-related discontinuations from the trial, no cases of endophthalmitis and no Zimura-related adverse events. Through month 18, the reported incidence of CNV in the untreated fellow eye was 11 patients (3.8%), and in the study eye was 3 patients (2.7%) in the sham control group, 8 patients (11.9%) in the Zimura 2 mg group, and 13 patients (15.7%) in the Zimura 4 mg group. The most frequently reported ocular adverse events were related to the injection procedure. 

    The Company plans to make additional supportive information regarding the 18 month results available in its public filings with the Securities and Exchange Commission.

    Geographic Atrophy

    Age-related macular degeneration (AMD) is the major cause of moderate and severe loss of central vision in aging adults, affecting both eyes in the majority of patients. The macula is a small area in the central portion of the retina responsible for central vision. As AMD progresses, the loss of retinal cells and the underlying blood vessels in the macula results in marked thinning and/or atrophy of retinal tissue. Geographic atrophy, the advanced stage of AMD, leads to further irreversible loss of vision in these patients. There are currently no U.S. Food and Drug Administration (FDA) or European Medicines Agency (EMA) approved treatment options available for patients with geographic atrophy.

    Zimura

    Complement factor C5 is a central component of the complement cascade and is believed to be involved in the development and progression of AMD. Zimura is designed to inhibit complement factor C5 cleavage into C5a and C5b. By inhibiting the formation of complement C5 terminal fragments, Zimura may decrease the activation of inflammasomes and the formation of membrane attack complex (MAC). This mechanism of action could potentially prevent or slow down the degeneration of retinal pigment epithelial (RPE) cells and slow down the progression of GA.

    Conference Call/Web Cast Information

    IVERIC bio's management team will host a conference call/webcast today at 8:00 a.m. Eastern Time to discuss the positive 18 month Zimura data. To participate in the conference call, dial 800-367-2403 (USA) or 334-777-6978 (International), passcode 7075082. A live, listen-only audio webcast of the conference call can be accessed on the Investors section of the IVERIC bio website at www.ivericbio.com. A replay will be available approximately two hours following the live call for two weeks. The replay number is 888-203-1112 (USA Toll Free), passcode 7075082.

    IVERIC bio

    IVERIC bio is a science-driven biopharmaceutical company focused on the discovery and development of novel treatment options for retinal diseases with significant unmet medical needs. The Company is currently developing both therapeutic product candidates for age-related retinal diseases and gene therapy product candidates for orphan inherited retinal diseases. Vision is Our Mission. For more information on the Company, please visit www.ivericbio.com.

    Forward-looking Statements

    Any statements in this press release about the Company's future expectations, plans and prospects constitute forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Forward-looking statements include any statements about the Company's strategy, future operations and future expectations and plans and prospects for the Company, and any other statements containing the words "anticipate," "believe," "estimate," "expect," "intend", "goal," "may", "might," "plan," "predict," "project," "seek," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions. In this press release, the Company's forward looking statements include statements about the impact of the COVID-19 pandemic on the Company's research and development programs, operations and financial position, its expectations to initiate enrollment in its second Phase 3 trial (ISEE2008) of Zimura in geographic atrophy secondary to AMD and to use its previously announced clinical trial of Zimura for the treatment of geographic atrophy (OPH2003) as a Phase 3 trial, its development and regulatory strategy for Zimura, the potential clinical meaningfulness of the results of clinical trials, the implementation of its business plan, the projected use of cash and cash balances, the timing, progress and results of clinical trials and other research and development activities, the potential utility of its product candidates, and the potential for its business development strategy. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company's development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, those related to the progression and duration of the COVID-19 pandemic and responsive measures thereto and related effects on the Company's research and development programs, operations and financial position, the initiation and the progress of research and development programs and clinical trials, availability of data from these programs, reliance on university collaborators and other third parties, establishment of manufacturing capabilities, expectations for regulatory matters, need for additional financing and negotiation and consummation of business development transactions and other factors discussed in the "Risk Factors" section contained in the quarterly and annual reports that the Company files with the Securities and Exchange Commission. Any forward-looking statements represent the Company's views only as of the date of this press release. The Company anticipates that subsequent events and developments will cause its views to change. While the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so except as required by law.

    ISEE-G

    (PRNewsfoto/IVERIC bio, Inc.)

     

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    SOURCE IVERIC bio, Inc.

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